Links to 803 Entry-Level Biotechnology & Life Science Jobs

This position will support system validation and product release processes, ensuring compliance with industry standards and regulatory requirements. You will play a key role in contributing to the development and improvement of validation procedures and driving overall product excellence. This is an entry-level, remote position. Successful candidates have a bachelor’s degree within an engineering discipline, a passion for technology, and exposure to system/software testing in the life science industry.

This position is responsible for conducting routine microbiological testing, documentation, and data analysis, of utilities, raw materials, facilities and equipment. Additionally, the microbiology technician will be responsible for upkeep of the laboratory, laboratory supplies, and other various routine laboratory tasks.

This position is responsible for completing project tasks; and serving as the Quality Control contact on one or more projects by carrying out laboratory experiments, completing assignments that are varied in nature, contributing to report writing and representing SurModics at meetings with customers.

We're looking for a Molecular Lab Technician (MLT) to help with day-to-day screening procedures for our molecular testing laboratory. We’re seeking a highly driven, motivated, and experienced Lab Technician that understands the PCR process, its importance, and work through each complex step with the upmost efficiency. The ideal Lab Technician will have patience, empathy, time management, and professionalism with patients, co-workers, and providers.

Roche Support Network is dedicated to providing exceptional support to customers. As a Field Engineering Specialist you will: Showcase your expertise in technical repair and installation for Roche assigned product lines. Offer valuable service to laboratory customers in your assigned territory. Provide routine technical support, on-site service, repair, and installation of Roche products. Serve as a customer contact for technical and service-related issues and perform preventative maintenance. Diagnose and resolve mechanical, hardware, software, and system failures. Document all activities, contribute to quality improvement, and focus on maximizing customer satisfaction.

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.

This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives.

The Pathologist Associate is responsible for supporting and assisting the Pathology and Pathology Operations departments in their daily operations. This position will perform tasks needed to be completed in the day-to-day operation. This position also includes performing the tasks of Macrodissection and Microdissection.

A Quality Assurance Technologist is responsible for a multitude of different tasks within the clinical molecular laboratory including the quality control testing of all molecular reagents prior to use on clinical samples, assisting the product development team with the validation of new assays and training current employees on new assays as well as new employees on established assays. This position is required to be well versed in various molecular techniques that include, formalin-fixed paraffin-embedded tissue macro-dissection, RNA/DNA extractions, PCR, RFLP, DNA methylation analysis, Next Generation sequencing and automated liquid handlers. Quality Assurance Technologists are expected to contribute technically and intellectually to enhance efficiency within the lab while ensuring that the quality of reagents and training program is maintained to the highest standard. This position works under the direction of the Director and follows standard laboratory procedures and policies.

Are you an experienced Clinical Lab Professional? If so, Labcorp wants to speak with you about exciting opportunities to join our team as a Technologist at the Sunshine Lab in Phoenix, AZ. In this position you will work in a fast paced, customer focused, and challenging environment, and will be a part of our overall mission at Labcorp: “Improving Health, Improving Lives”.

This position works supports the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Process Engineer performs analyses to develop design specifications and performance requirements. Provides technical information concerning manufacturing or processing techniques, materials, properties and process (advantages/limitations) engineering planning. Selects techniques to solve problems and make sound design recommendations.

The mission of the Manufacturing Engineering group is to provide manufacturing technology and robust solutions that commercialize new products and that support continuous improvement in production. Project opportunities are designed to develop professional work knowledge and abilities and to support the efforts and projects that have global importance to the success of the business. Area of work involves manufacturing and business processes with interaction between production, cross-departmental engineering groups, and other cross-functional teams (such as Regulatory, Quality, R&D, Supply Chain, IT, etc.) in executing and coordinating business operations systems projects and activities. Essential job functions include creating and executing an integrated cross-functional project plan.

The primary duties of this position are to assist other Automation Team members in assay automation development, as well as support the Clinical Laboratory by aiding in recovery and troubleshooting validated laboratory instruments. This position also plays a role in designing, optimizing, validating, maintaining, and troubleshooting automation tools for our clinical diagnostic assays.

Are you passionate about pushing the limits of technology to advance our understanding of the life sciences? So are we! We’re looking for a highly motivated and experienced Mechanical Engineer to join a fast-paced start-up developing tools that will transform functional cell biology research. The ideal candidate will have strong engineering and problem-solving skills, a solid grasp of mechanical design fundamentals and some exposure to optical systems, microscopy and bio-engineering or biology. As Mechanical Engineer, you will be part of a small team designing, developing, specifying and testing Bifrost’s hardware products. Additionally, you will play a role in product definition, development and verification testing.

We are seeking an MEMS Engineer or Senior MEMS Engineer to join the team full time to accelerate the development of Hydropore in our Berkeley office. Indee Labs is headquartered in Berkeley, CA and accommodates remote work. This position will be located in Berkeley, CA and occasional work travel may be required.

We are seeking a Bioengineer or Senior Bioengineer, Immunology to join the team full time to accelerate the biological development of Hydropore at our Berkeley office. Indee Labs is headquartered in Berkeley, CA and accommodates remote work. This position will be located in Berkeley, CA and occasional work travel may be required.

At Meissner, we provide B2B technical solutions, that are deployed to improve the human condition. Our customers use our products and technologies to develop new therapeutics and many familiar products that support our modern lifestyle. At the core of these products, are in-house technologies that are developed and maintained by highly talented and self-driven engineers and scientists. Projects are typically heavily weighted towards chemical processes and materials science at an R&D/prototype scale to pilot and production scales. The R&D Scientist will undertake independent research projects and/or investigations or be responsible with specific parts of larger projects, with a higher degree of independence.

Test Engineer is responsible for designing, developing, and testing mechanical systems and components. The engineer is responsible for producing and implementing designs and test procedures analyzing and troubleshooting mechanical systems and components and developing and testing prototypes. The engineer will participate in daily technical meetings to review project progression, performance of team members and recourse management. This position will serve as great transition from education to junior level for a young professional to further engineering skills in an array of projects.

As we continue to grow as QuidelOrtho, we are seeking a Quality Engineer. This position is responsible for owning and coordinating all Quality Engineering functions and activities for the defined processes. This individual is also responsible for supporting the Production, Quality Control, Engineering and Quality Assurance departments and the associated activities, which include receiving inspection, in-process inspection, and finished goods inspection in achieving and exceeding company goals and objectives. In addition, this individual is responsible for supporting the administration, implementation, and continuous improvement of the quality systems associated with non-conforming materials, inspection control plans, and corrective/preventive action. This individual also supports corporate strategic goals and objectives through internal audits, support of manufacturing operations, quality support for manufacturing processes for new product development/ product improvement projects, and support of manufacturing process improvement projects.

Reviews/ approves Design Control documentation (e.g. Design Verification, Process, or component validation), Leads Test Method validation activities associated with Design Verification activities, Represents Quality in New Product Development (NPD) project team meetings & Design Reviews, Prepares and releases Inspection Plans and Quality Control Inspection Criteria (QCICs) that supports qualification of purchased components, Audits Design & Development activities to ensure compliance with procedures and standards, Supports Risk Management activities for new or legacy products. This includes Risk Management Planning (RMP), Risk Analysis including post-market risk assessments, create Risk Management Reports, Leads complaint investigations and trend reporting for InHealth Technologies (IHT) products, Analyze internal and external quality product performance trends and address non-conformities, Represent Quality engineering in Engineering Change Order process for IHT products, Participates in both Internal and/or External audits, Participates in any product recalls or field actions

Responsible for clinical trials administration to ensure the most effective and efficient conduct of clinical research studies.

The Senior Manufacturing Associate will actively contribute to the manufacturing and technology transfer projects at the Bionova Scientific Fremont location. As part of the Purification/Manufacturing group, you will have opportunities to work on a wide-ranging set of projects for troubleshooting and investigations, system and workflow implementation, and tech transfers of processes into the GMP manufacturing facility. The role will provide hands-on execution of complex experiments in a team setting. The role will support GMP readiness and manufacturing activities. The scope of responsibilities may include but are not limited to Document writing (SOPs, Equipment URSs, etc.), equipment validation execution support and single-use assembly design.

Our Product Engineer plays a strategically important role in ensuring the company’s business success. The primary responsibilities include, but are not limited to, supporting Field Service Engineers (FSEs) and Field Application Scientists (FASs) groups with technical support, authoring and reviewing Best Known Practices (BKPs) for field deployment, and coordinating the rollout and implementation of Engineering Change Orders (ECOs) in the field. In this Product Engineer (PE) position, you will train FSE’s on best practices and be the point of contact for field escalations. PEs are system experts and sometimes work side by side with R&D to gain a deep understanding of the system. PEs will help define problem statements, develop mitigations, and are a key contributor to Corrective Action Preventative Action (CAPA) plans.

Responsible for exercising independent judgment in conducting research on in vitro ADME screening (ADME: Absorption, Distribution, Metabolism, and Elimination): plan experimental approaches; design and carry out bioanalytical tests of various compounds for the potential development of human therapeutics; analyze and interpret experimental data and prepare reports of findings. Design and perform procedures in ADME assay projects by operating lab equipment, including integrated hardware, software, optical and fluidic subsystems. Conduct sample bioanalysis and develop bioanalytical methods for the quantitative analysis by using mass spectrometry. Document information on procedures, modifications, and methods; maintain records of experiments and results in the accessible format.

PBL has immediate openings for a Research Assistant I/II/III in the In Vitro Services Department. The Research Assistant reports to the Director, In Vitro Services. The In Vitro Research Assistant is a laboratory level job focusing on the development, optimization, and execution of a variety in vitro (i.e., cell-based and noncell-based) test methods. Successful candidates will be familiar with laboratory procedures including the use of analytical balances, calculating, and preparing dilutions, pipetting, measuring pH, documenting study activities, and analyzing/interpreting data. The In Vitro Research Assistant is expected to perform under minimal supervision. Research Assistants may also contribute to general laboratory operations including equipment maintenance and maintaining a clean and organized laboratory environment.

The Neurotoxin Research Group at AbbVie is seeking a highly motivated and innovative candidate for the role of Associate Scientist II, In vivo pharmacology. The successful candidate for this position will contribute to projects aimed at the pharmacological characterization of protein-based therapeutics. Under supervision by senior personnel, he/she will be required to work on a variety of in vivo animal pharmacology models to help characterize and evaluate biological compounds. This individual will need to organize, analyze, interpret, and present results to senior personnel or in team meetings. A good understanding of animal models, neurology, and pharmacology is required. Experience in handling and injecting rodents by different routes is required. Working knowledge of neuroscience and in vivo motor pharmacology is an advantage. The successful candidate will be collaborating extensively with other Research Associates and Scientists, while taking personal responsibility for the success of assigned tasks and projects.

This fast-paced position will be responsible for the support and continuously improve current manufacturing process, through technical and process innovation for the manufacture of neurovascular medical devices that save patient lives.

The Clinical Research Associate is responsible for clinical studies, site management and compliance monitoring of assigned clinical projects undertaken in support of a given product line or marketing initiative. This position must ensure that all activities will be conducted in accordance with Government Regulations (FDA, MDD and International), Good Clinical Practices (GCP) and Department Operating Procedures (DOP).

The Laboratory Assistant or Technician will follow the guidelines set by CLIA and the CA Business and Professional Code of Regulations (BPC: 1212 and 1269) for unlicensed laboratory personnel.

Reporting to the Director, Engineering & Operations, the Operations Engineer will have responsibility for key aspects of ABS’ product manufacturing and operational processes. Assuming the dual roles of that of a Manufacturing Engineer and Facilities Engineer, the Operations Engineer will work on simple-to complex, high visibility/value projects with a focus on supporting production. The Operations Engineer will also support the Facilities function in a multitude of ways – compliance, procedure development, equipment maintenance, organization and much more.

Maintains demonstrated proficiency with all applicable Standard Operating Procedures. Performs semen evaluations to screen, process, and preserve for future clinical use. Execute an array of laboratory procedures including but not limited to: Daily setup of all laboratory equipment and daily QC. Intrauterine (IUI) and intracervical (ICI) insemination semen preparation. Sample Qualification- post-thaw sample analysis with both manual and automated analysis. Preparation of bodily fluid including blood, urine, and semen packing for specimen transport to reference laboratories. Cryogenic procedures including routine liquid nitrogen storage-tank verifications, internal vial transfers between tanks, vial quality control checks, preparing samples and shipping containers for vial movement. Conducts and accurately records all required daily, monthly and yearly quality control checks; responds with corrective action when needed. Communicates any errors, accidents or incidents to Management and records in associated tracking and record logs. Performs routine cleaning of laboratory equipment. Complies with all regulatory, quality assurance, quality control, standard operating, and safety procedures to audit-ready standards. Completes Bi-annual and annual proficiency and competency assessments. Participates in the review of standard operating procedures. Responsible for aliquoting and maintaining necessary aliquot-inventory levels for all media to maintain production. Responsible for lab supply maintenance. Performs all necessary opening and closing duties. Provides coverage for donor related tasks such as identification and qualification as needed. Always while ensuring privacy and maintaining the utmost professionalism. May perform phlebotomy if licensed. Other duties and projects as required.

PacBio is seeking a driven, self-starter for the position of Reagent Quality Control (QC) Scientist. In this role, the QC Scientist is required to complete high quality work through QC assay execution from analytical assays (e.g., HPLC, fluorescent assays, etc.) to Use Test assays involving PacBio’s sequencing platforms. In addition, the individual will complete QC assay validation and transfer activities, execute stability studies, trend and interpret data, troubleshoot QC failures, and complete sustaining QC process improvements in the Reagent Manufacturing Organization. In this multi-faceted role, the ideal candidate is organized, independent, detailed oriented, process driven, quality driven, and skilled at problem solving.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These individuals build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices. Execute microbiological and/or analytical methods to facilitate in-process testing under applicable cGMP guidelines, as well as contribute to the prompt reporting of results to meet the required timetables of internal customers. Perform environmental monitoring sampling and testing of facilities, equipment, and utilities. Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports. Perform and collaborate with co-workers to appropriately share general housekeeping activity assignments, and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness. Assist with monitoring and the control of laboratory supply and critical reagent inventories. Perform growth promotion of media and microbial identification testing. Qualify as trainer for specified methods, provide training to less experienced staff. Provide on call coverage to support oversight of QC laboratory equipment functionality. Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, perform initiation of investigation records within required timeframes. Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols. Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization. Perform other responsibilities as deemed necessary.

The GMP Manufacturing Technician position is responsible for performing manufacturing activities in compliance with company procedures and external regulatory requirements at the Petaluma and Novato ISO 13485 sites and as directed by the GMP Manufacturing Management. This role will be on our Synthesis team in Novato Lab.

The GMP Manufacturing Technician position is responsible for performing manufacturing activities in compliance with company procedures and external regulatory requirements at the Petaluma and Novato ISO 13485 sites and as directed by the GMP Manufacturing Management. This will be in our Kit Lab in Novato. Techs do final dry down (lyophilizatoin), column packing for purification, aliquoting and kitting of product.

We are looking for a Laboratory Technician to join our R&D team in Palo Alto. The role is part of a small group that divides their focus between innovative new projects and product development. The ideal candidate will be extremely organized, familiar with basic laboratory techniques, and excited to learn and grow within the team. Technicians will divide their time between hands-on laboratory work, data analysis, and lab organization and maintenance. Candidates with knowledge and experience of PCR, library preparation, NGS sequencing or RNA seq will be given preference.

The Oligonucleotide Production Technician I - Purification will perform tasks associated with the purification of oligonucleotides in a high throughput, time sensitive manufacturing environment.

A CLA performs laboratory duties under the supervision of a licensed CLS. This position is for assisting the CLS and for sample processing, equipment operation and maintenance, and documents.

The Clinical Laboratory Associate (CLA) II is responsible for supporting the daily operations of the Clinical Laboratory and assisting the Clinical Laboratory Scientist (CLS) during patient testing. In addition to the primary role of CLA, there will be a need to provide back-up support to the other groups (Reporting, Biospecimen Management, QC, etc.). The CLA II may serve as a lead to the CLA team to coordinate tasks, divide workload, manage equipment usage schedule and documents reviewing/filing process as assigned. The CLA II has demonstrated the skills and competency to assist the CLSs in automated sample processing and in all other support functions.

The Clinical Laboratory Associate II (CLA II) is responsible for supporting the daily operations of the Clinical Laboratory and assisting the Clinical Laboratory Scientist (CLS) during patient testing. In addition to the primary role of CLA, there will be a need to provide back-up support to the other groups (Reporting, Biospecimen Management, QC, etc.). The CLA II may serve as a lead to the CLA team to coordinate tasks, divide workload, manage equipment usage schedule and documents reviewing/filing process as assigned. The CLA II has demonstrated the skills and competency to assist the CLSs in automated sample processing and in all other support functions.

The Technology Development Department is responsible for developing, validating, and implementing the tests used by Guardant Health for cancer detection. This role will be within the Product Development wing of Technology Development. The Product Development group is primarily responsible for late-stage assay development, including interfacing with early-stage assay development to finalize the assay, verifying and validating the product, and supporting transfer of the product to the Guardant health clinical laboratory and subsequent launch. The current focus of the role will be supporting regulatory submissions to both FDA and ex-US regulatory agencies as subject matter experts in analytical and clinical validation studies. However, the full scope additionally includes LDT and RUO product development and validation utilizing standard design control processes.

Juvena Therapeutics is seeking a highly motivated Vivarium Research Technician to join our dynamic research team in Redwood City, CA. This role will contribute to the growth of our research portfolio by supporting vivarium operations to advance the development of novel rejuvenating therapies. This position is ideal for a talented, highly motivated and results driven individual who will thrive in a fast-paced, innovative, start-up environment. The individual will report to Senior Scientist/Director in vivo Pharmacology.

As a Clinical Trial Assistant II in Clinical Operations, initially reporting to the Director Clinical Operations, you will be responsible for acting as a central contact for the clinical study teams and assist with the clinical execution and management to support RevMed clinical trials.

The Field Service Engineer position at HighRes Biosolutions is the primary role responsible for installation, maintenance, troubleshooting and repair of systems and devices at customer sites. This position specializes in the hardware aspect of the products, coordinating with the Automation Support Engineer role in Customer Support and collaborating with the manufacturing and commissioning department (software and configuration-focused) for full coverage support of the products. Levels I and Junior are roles for carrying out Field Service Engineer responsibilities in either learning or assisted modes, with oversight and assistance from a team lead, supervisor, manager, or skilled technical Customer Service colleague(s).

ALSTEM is looking for a highly organized and energetic Research Associate with a B.S or M.S. degree to join its scientific team. The candidate will be responsible to work as a team at all levels which will include but will not be limited to product testing and QC, and custom service projects following SOPs and protocols to support customer workflows.

Perform biochemical and cell-based assays, assay development, protein production and characterization, ELISA, western, biomarker studies and use various molecular biology tools. Work with a team of scientists towards establishing various protocols with high quality, generate reproducible SOPs compatible with cGMP process for technology/knowledge transfer for clinical grade production. Develop and optimize protocols for various cell and molecular biology studies, such as RNA preparation and RT-PCR. Protein production, purification, characterization and analysis by ELISA, SDS-PAGE, western, other biochemical techniques. Generate data for Company newsletter, website, social media, printed journals etc. Analyse data and prepare reports. Prepare SOPs for various experimental procedures. Prepare data for internal and external presentations, communications and publications. Participate in team meetings and scientific discussions

We are currently seeking a Drug Product Manufacturing Associate I who is responsible for executing GMP production of injectable pharmaceuticals by following all applicable SOP's. Manufacturing associates are responsible for preparing equipment and materials for GMP aseptic production and operating equipment such from glasswashers, autoclaves, depyrogenation ovens and automated filling machines.

AlivaMab Biologics is seeking an outstanding individual to join our Antibody Engineering Team to support molecular cloning for the generation of expression constructs. As part of an interdisciplinary research team, the selected individual will be a key contributor to the progression of exciting antibody discovery and engineering efforts and contribute to technological development in the Molecular Biology group. This position will report to the Senior Scientist, Antibody Engineering, and work closely with scientists in the Protein Sciences and Antibody Discovery teams.

We are looking for a dedicated and detail-oriented Training Specialist to join our team and drive excellence in our GMP manufacturing operations. In this position, you will play a critical role in designing, implementing, and continuously improving training programs for our Cell Therapy Manufacturing Team. You will help ensure that all personnel maintain a high standard of skill, knowledge, and compliance with GMP and regulatory requirements, ultimately supporting the safe and efficient production of our innovative therapies.

The Process Development Associate will play a key role in advancing Capricor’s biomanufacturing efforts by evaluating, improving, and scaling processes for therapeutic production. This position focuses on optimizing product yield, reducing costs, and ensuring scalability—from small experimental batches to large-scale manufacturing—while maintaining quality and efficiency. Reporting to the Process Development Director or Associate Scientist, the associate will collaborate with cross-functional teams to support the production of cell -based therapeutics, troubleshoot challenges, and implement innovative solutions. This role is ideal for a hands-on, detail-oriented professional eager to contribute to cutting-edge biotech advancements.

The purpose of the In Vivo Research Associate I position is to provide support on In vivo studies within the In Vivo Pharmacology group meeting Company's goals, objectives and quality standards.

We are on the lookout for a top-tier Process Development Engineer 2 who brings a “can do” attitude and a desire for deep technical expertise in equipment, test design, statistics, and data analysis. As an integral part of our Engineering team, you will be instrumental in developing and fine-tuning manufacturing processes for medical devices, ensuring they are robust, efficient, and fully compliant with regulatory standards. Join us and make a significant impact on the future of medical technology!

We are seeking an experienced Senior Manufacturing Technician who will play a pivotal role in supporting the manufacturing and QC of reagent consumables for Element Biosciences. This will include synthesis, purification, and analysis of key intermediates. This is an incredible opportunity for someone who is passionate about making a difference and looking to further their career in the biotech industry. This role will report to our Associate Director, Consumables Manufacturingand will be a San Diego based (on-site)role.

The Manufacturing Associate I or II, Tissue and Cell Therapy is responsible for performing well regulated GMP aseptic cell culture activities including media preparation, cell thaws, cell expansion, cell harvesting, and cryopreservation using standard cell culture technologies in a cleanroom environment. The Associate will be responsible for following Batch Production Records, Standard Operating Procedures, and work instructions in manufacturing spaces. The Associate will be responsible for participating in the maintenance of critical supplies, equipment, product testing, product storage and product distribution.

Research Associate 2 is responsible for designing and performing experiments while collaborating and communicating effectively.

Assist with in vivo pharmacology experiments for preclinical contract research. Perform histology and immunohistochemistry work and other special stains, when needed. Schedule studies, review protocols, data and reports. Establishes scientific standards and new initiatives. Write and review SOPs. Enter data in study management software. Participates in drafting quotations. Develop, implement, optimize, and validate animal models in different disease areas. Effectively communicate with internal colleagues and external clients to promote a world-class service.

Biotheranostics, Inc., a Hologic company, is looking for an experienced research associate to join our oncology research and development team to strengthen our efforts in oncology diagnostic product development and research. Biotheranostics is a leader in the development of evidence-based biomarkers to address unmet medical needs and is experiencing dynamic and rapid growth. Its leading products are the Breast Cancer Index® (BCI) and CancerTYPE ID® (CTID). The company is based in San Diego, CA and offers testing services through its CLIA-certified, CAP-accredited laboratory.

The Facilities Engineer 1 will be responsible for developing and executing validation protocols as related to new or upgraded facilities and utilities as used for medical device manufacturing. This person will work cross-functionally to assist with the development of requirements based on their expertise in clean rooms, water systems, HVAC and other systems used to support a regulated manufacturing environment. This person will also be responsible for report writing.

Modulo Bio is seeking a Stem Cell Scientist to develop and scale an induced-pluripotent stem cell (iPSC)-based in vitro model of the neuroimmune system. Modulo Bio is building a proprietary immune cell modeling platform, which incorporates human genetics, functional genomics, molecular biology, cellular and tissue profiling, disease model engineering, and advanced computational models. The successful candidate will build a complex cell model platform with the goal of improving our understanding of human biology and therapeutic interventions to inform early and late stage pipeline efforts. Candidates with an eagerness to work within a highly leveraged, team-driven, dynamic research environment will be prioritized. The candidate will work in close collaboration with our internal Computational Biology group which is focused on next-generation sequencing (NGS), functional genomics, cell or tissue profiling, and bioinformatics analyses of cutting-edge large-scale genetic screening or single-cell technologies to enhance our analytic capabilities and to reveal the underlying mechanisms of human disease.

Checks reactor system for proper operation in accordance with SOP and/or operation manual. Under general supervision and direction, measures and mixes ingredients according to the BPR (Batch Production Record). Dispensing of raw materials from Pharmastore for Synthesis. During processing, monitors chemical reactions (color and completeness of chemical reactions) and under general direction of supervision and/or senior Production Chemist personnel responds with appropriate actions to ensure proper processing. Using established procedures (safety and process) and under general supervision, performs intermediate chemical processing steps. Prepares solutions for purification and samples. Under general supervision, purifies crude peptide by using HPLC’s. Conducts lyophilization process according to established guidelines. Performs drying processes in accordance with established processes and procedures. Reports any problems or issues regarding equipment used in processing to supervision and/or senior Production Chemist personnel. Performs in-process checking of the fractions by using analytical HPLC and reports results to supervision and/or Sr. Production Chemist personnel. Is responsible for maintaining high safety, housekeeping and cleanliness standards. Performs any and all additional duties as required for this position.

Join our dynamic Molecular Cellular Immunology (MCI) team as a Recombinant Manufacturing Associate, where you’ll play a pivotal role in creating groundbreaking recombinant protein research products. In this hands-on position, you'll be involved in every step of the production process, from recombinant protein expression to purification. Your expertise will be key in tasks like preparing buffer solutions and cell culture media, performing bacterial cultures, and using cutting-edge techniques to affinity purify recombinant proteins. You'll also be responsible for DNA isolation in accordance with established protocols. This role offers exciting opportunities to expand your skill set, with potential additional responsibilities including transferring products to other teams for testing, preparing detailed product and project documentation, and managing inventory and records for recombinant protein products.

At BioLegend (a division of Revvity, Inc.) we develop novel, cutting edge products and offer custom services to help with scientific innovation and discovery. We are currently looking for a talented, detail oriented person to join our growing Product Development team. The potential candidate will assist with development of new products for cell analysis such as antibodies, multi-color panels, and reagents for analysis of cell metabolism and cell imaging. The successful candidate must be a self-motivated, team player, able to communicate effectively with a multi-disciplinary team and must possess excellent organization skills.

The Entry Level Lab Technician I will be responsible for the processing and testing of various blood samples. Sample processing will include, but is not limited to: PBMC, T, B, & NK cell isolations. Other assigned duties may include cell counting, aliquot preparation, accessioning, reagent creation, proper storage, flow cytometry lab services. Initial samples will be from both Leukopaks and blood samples or its derivatives. This role will also require experience with LIMS systems and commercial laboratory operations, including the internal communication of project details with Sanguine personnel as well as the ability to work as a team.

We’re seeking an RA or SRA to join our dynamic induced pluripotent stem cell (iPSC) research and manufacturing program. The successful candidate will manage iPSC lines and their differentiation to different cell types, like cardiomyocytes, microglia, neurons, and astrocytes. These differentiated iPSC lines will be used for internal R&D projects, commercial research contracts, and manufacture for sale. You will evaluate and validate differentiated cell lines with biomarker detection methods like ICC or flow cytometry, and investigate and characterize cellular function using Vala’s live-cell fluorescent imaging technology. You will work in a close-knit, fast-paced team environment and adapt readily to changing needs as projects and technologies evolve.

Veracyte is seeking an exceptional candidate for a full-time Research Associate in the Product Development team at our San Diego location. The Product Development team at Veracyte is tasked with developing high impact diagnostic assays to address unmet clinical need and improve patient outcomes. This on-site role will be primarily working in the San Diego laboratory supporting the Product Development team in achieving both short- and long-term goals and is a fantastic opportunity to gain hands-on, applied skills within an R&D team at an industry-leading diagnostics company.

We are seeking a talented and highly motivated Senior Research Associate to support our diverse antibody therapeutics pipeline. This position will offer exposure to drug development, from early research through development/manufacturing, with ample opportunity to learn new methods, design experiments, and present your work.

Engineers who are in an early career stage as an individual contributor and are developing their general knowledge and skills. This a contract position.

Provide engineering support for introduction of new products and alternate repair activities. Function as Project Coordinator on more complicated projects as defined by the Manager by providing technical information to other project participants recommending cost effective procedures tracking and maintaining implementation dates and documenting completed projects. Provide support to Associate Engineer on his/her assigned projects.

This non-licensed position is accountable for assisting with general support for the laboratory, following all applicable policies and procedures.

The Quality Engineer I supports the ongoing quality of Orchid's legacy products & processes and works cross-functionally to sustain the business.

The Biologics Drug Product Development group within AbbVie is a global organization responsible for developing and characterizing drug product formulations and manufacturing processes for biologic therapeutics (antibodies, antibody-drug conjugates (ADCs), neurotoxins, and novel biologic formats) from preclinical development through clinical proof of concept. We have an exciting opportunity available for an Associate Scientist I/II to join our team at our Bay Area site in South San Francisco, CA. This position requires an onsite presence and involves lab-based functions. Successful candidates will thrive in a collaborative lab environment.

Neurona Therapeutics is a clinical stage biotechnology company based in South San Francisco, CA that was created to develop cell-based therapies for neurological disease. We have an opening for a Preclinical Research Associate who will contribute to ongoing programs and build new animal models to study modulation of neural circuits and support translational development of cellular therapeutics.

This position supports the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. This individual will work with supervisors, engineers, technicians, and operators to address problems and opportunities identified on manufacturing lines. He or she will be accountable for quality, safety, product output and yield initiatives, as well as providing line support on a daily basis.

The Associate Remote Care Product Engineer is responsible for understanding the integrated set of standards, sub-standards, and assemblies needed to provide remote care support for Abbott CRMD devices. Applies an interdisciplinary, collaborative approach to plan, design, develop and verify a life-cycle balanced system of systems and system/subsystems solution(s) which satisfies customer/operational needs and public/regulatory acceptability. Troubleshooting complex systems and interactions with the full line of remote care capable Abbott devices and supporting hardware will be the primary focus.

The Associate TPM Project Engineer is an engineering professional who applies scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete assignments related to a specific technical field or discipline.

The Quality Analyst will be responsible performing the daily quality operations for Quality Lab Services within the Quality organization. You will manage stability management, basic investigation activities, coordinating external lab testing, managing analytical instrument preventive maintenance, inventory management, compiling critical quality attributes data for the Product Quality review and Yearly Biologic Product Report, initiating deviations, and participating in quality process improvements for the QC labs. You will report to the AQC Manager.

The Manufacturing Associate Support provides support for: Production Operations and multiple aspects of cGMP contract cell culture manufacturing in strict compliance with cGMP, under Standard Operating Procedures in a multi-product manufacturing facility, including, but not limited to production, documentation, writing reports, requesting and purchasing materials, and scheduling equipment services and calibrations. The Manufacturing Associate will play an integral role in ensuring the production and on-time release of quality products. The Manufacturing Associate will conduct themselves in a manner representing the core values (Integrity, Adaptability, Innovation, Teamwork, and Passion) of the company with the common purpose of improving patients’ lives by consistently delivering high-quality biopharmaceutical products.

The Research Associate, Process Development Downstream will provide laboratory support for Process Development by assisting in the downstream process and/or method development. The Research Associate may be assigned various tasks within the department and outside the department as needed.

As an Associate Specialist, Quality Assurance, you will be a critical part of ensuring top-notch quality for our products and services. You will be responsible for various administrative tasks associated with Avid's electronic document management and training systems, issuing, and reconciling equipment logbooks and laboratory notebooks, and providing both formal and informal training to coworkers on relevant processes such as quality systems, training, and GMPs.

In this role, you will support QC GMP operation and key assays for release, in-process, and stability testing; Other activities include but not limited to data trending, archiving, lab/equipment maintenance, reagent preparation/supplies ordering, supporting EM and microbiology testing. Final job title will be determined based on candidate experience level.

The Clinical Data Assistant 2 is responsible for activities including data entry, primary and secondary quality control (QC), and release of RQCQ and EAF requisitions across accessioning platforms. Responsibilities also include managing RITM ticket requests, overseeing secondary passes for special studies, and ensuring team tasks are completed daily. Additional duties may involve the receipt, storage, and shipment of clinical specimens, routine troubleshooting, and guiding entry-level staff on basic department procedures.

The Chemist function is to work in a cGMP regulated environment manufacturing active pharmaceutical products (APIs) as well as performing related activities at Bachem.

The Manufacturing Technician I performs fundamental tasks within a GMP environment in support of more complex manufacturing operations. The Tasks include, but are not limited to, cleaning and maintaining the work place so that it meets the standards for controlling bioburden levels; cleaning operating equipment per applicable procedures so that it meets the standards established to prevent product contamination and maintaining records/logs neatly and accurately and in accordance with current standard procedures. The technician performs job tasks in a safe manner while following specific department safety rules.

The Quality Control Associate I - Microbiology will focus on performing microbial and environmental monitoring assays, facility qualification, and testing of purified water and cleaning samples. This position may also review data, execute validation studies, and support commissioning of laboratory instruments. The ideal candidate will be highly motivated, organized, and have the ability to work independently. Experience in a GMP Microbiology laboratory is preferred.

The Manufacturing Chemist position performs a wide variety of technical duties to support small scale manufacturing operations.

Performs all technician tasks accurately and efficiently without supervision. Initiates expert technical advice to customers and completes all tasks in the Technician Training manual. Maintains a high level of housekeeping and attention to detail.

The Process Development Associate supports and executes laboratory studies within the KBI Process Development organization at KBI under general supervision. The Process Development Associate is able to execute lab work, with documentation and reporting that is consistent with Process Development compliance and Quality standards. The Process Development Associate is able to author basic operational documents for routine unit operations within the laboratory organization. The Process Development Associate is capable of executing lab studies from written documents and applies standard scientific approaches to solving technical problems. The Process Development Associate may serve as the point of contact for a specific laboratory project. The Process Development Associate works under the general supervision of laboratory management with work reviewed for soundness and accuracy.

Analyst position in a growing team that supports a variety of testing in support of the manufacturing of biopharmaceutical products in a contract development and manufacturing space.

Novo Nordisk Global Nucleic Acid Therapies (GNAT) is seeking highly motivated scientists to join its CMC Chemical Development team in Boulder, Colorado. The candidate will be expected to be a key technical resource developing innovative solutions for scalable syntheses, work-up, purifications, and isolations of oligonucleotides, establishing improvements in purity, yield, reproducibility, throughput and environmental impact. The successful candidate will ideally have a strong organic chemistry understanding with exposure to principles of process development, optimization, scale up and tech transfer into a manufacturing setting. This position will support therapeutic programs in multiple disease areas and will contribute to the development of scalable processes supporting Novo Nordisk oligonucleotide programs. Qualified candidates will be expected to work well in a collaborative team environment and be able to independently execute research across a wide range of oligonucleotide and organic chemistry projects.

Prepares and organizes samples for testing, for example, sample racking, aliquoting and tube preparation. Responsible for labeling, handling, processing or preparation, and transportation and storage of specimens. Identifies sample problems and assists in resolving appropriately. Demonstrates problem solving ability on service and production issues. Prepares testing equipment and assists with preventive maintenance. Notifies appropriate technical staff of equipment problems. Assists licensed personnel (CA only) or delegated supervisor (non-CA) in the pre-analytic and post-analytic testing activities, other than trainees, in a licensed clinical laboratory. Prepares pre-analytical reagents and controls using automated or fixed volume measuring devices. Submits documentation to appropriate staff for approval to use. Prepares and maintains complete and accurate records of reagents or media using established procedures, formulas, stock solutions and fixed volume measuring devices. Maintains inventory of consumable items including reagents and supplies. Orders, unpacks, logs, dates and stores reagents/supplies upon receipt and properly rotates stock for use. Performs inventory of laboratory items including restocking the benches and equipment inventory. Sorting and accessioning incoming specimens into appropriate LIS, then delivering to designated testing platform/department. Performs data entry or transcribes data from previously recorded results to computer for data reduction and prepares for licensed personnel's review. Tallies workload data and prepares reports as requested. Assists in the performance of quality control procedures. Prepares protocols/logs or other appropriate documents. Identifies specimen problems and demonstrates ability to appropriately resolve or elevate to licensed personnel (CA only) or delegated supervisor (non-CA). Assists a licensed person (e.g.: CLS) with performance of validation verifications and other Research and Development (R&D) activities, as applicable. Trains other Lab Associates. Supports Training Programs, where applicable. Takes initiative in making suggestions to improve efficiency and productivity and provides consistent feedback. Is a resource for process improvement. Demonstrates leadership through accountability and collaboration in daily activities. Answers phones, transfers, or takes accurate messages. Maintains the confidentiality of client information. Helps to ensure the laboratory areas are neat, clean, and o

The Associate Product Sustaining Engineer works with direction from senior Engineering staff on projects that focus on legacy product systems and design and development of medical devices.

Revvity has an exciting opportunity for an enthusiastic Associate Scientist for molecular biology/viral production. The Associate Scientist position will perform primary tasks in an ISO 9001:2015 biology manufacturing laboratory in Lafayette, CO. Key responsibilities for this position include a wide array of duties related to the processing and preparation RNAi and Gene Editing products including molecular biology bench work, cloning, viral production, nucleic acid purification, collection replication, inventory control, and order packaging. The position will require the ability to learn and to troubleshoot various aspects of molecular biology and microbiology.

The Associate Scientist, Manufacturing will work within a team to perform kilogram scale organic synthesis of pharmaceutical drug substance. The Associate Scientist will operate chemical manufacturing equipment and execute detailed written instructions from a batch record under Good Manufacturing Practice (cGMP) conditions. In addition, the Associate Scientist is responsible for maintaining the manufacturing suites for activities by properly setting up, breaking down, operating, and cleaning production equipment for both GMP and non-GMP drug substance manufacturing operations. An Associate Scientist in manufacturing will operate under and develop subject matter expertise in cGMP practices and Good Documentation practices (GDP) within the Quality Management System.

Under general supervision, provides office and laboratory support to the Technical Services group in the MS&T department, which includes a variety of technical documentation activities, administrative activities, product investigation activities, and related tasks.

Gain an overall understanding of drug development and maintenance of the full chain of sample custody for regulatory compliance. Support implementation of Laboratory Information management System (Watson LIMS) for sample management and storage. Sample management and reconciliation, kit preparation and verification, and document preparation related to biological sample collection, storage, and shipment for clinical trials. Streamline inventory management, consumable ordering, and other documentation requests for Quality Assurance Unit. Help maintain ultra-low temperature (ULT) freezers and refrigerators and associated electronic logs and records. Learn bioanalytical techniques for the analysis of drug and biomarkers in biological matrices. Follow appropriate safety and study requirements by reading, understanding, and following Standard Operating Procedures (SOP), Good Laboratory Practices (GLP) requirements, and Sponsor Study protocols. Support business development and marketing activities, foster client relationships, and help onboard new sponsors

The Image Analyst I performs analysis and quality control (QC) on imaging data and metadata. Image Analyst I personnel are responsible for quantitative results generated in an imaging study. Analysts will be trained on all assigned analysis pipelines. Following demonstration of proficiency, analysts will contribute toward QC and troubleshooting of complicated analysis cases. Image Analyst I staff are assigned to multiple projects where they will work under the supervision of the project’s lead analyst. Analysts may also be asked to contribute to other analysis-related duties (creation and editing of SOPs, ad-hoc efforts, etc.).

Responsible for assisting chemists in performing various purifications of target compounds using various methods, including, but not limited to preparative high performance liquid chromatography (prep HPLC), normal phase and reverse phase chromatography, and recrystallization.

Agilent Technologies is seeking a Production Chemist for its manufacturing facility in Newport, Delaware. The Newport site is part of Agilent’s growing Consumables and Supplies Division (CSD), with a focus on liquid chromatography products. Agilent’s product quality and technological innovation lead the market. As a leader, we are entering new phases of product transformation with increased emphasis on new product and process innovation, process standardization and production efficiency.

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We have an exciting opportunity available for a Laboratory Technician - Automation in Boca Raton, FL! The Laboratory Technician - Automation performs automated laboratory testing to support hyperimmune products for ADMA Biologics. This position is responsible for the receipt, testing and on-time delivery of donor testing and maintaining a cGMP compliant laboratory. Maintaining communication with group leader or department manager to support cross-function relationships with plasma centers and ADMA plasma operations.

Performs a variety of quality control tests on products at various stages of the production process to ensure compliance with quality and reliability standards. Records statistical data. Analyzes data and writes summaries to validate or show deviations from existing standards. Recommends modifications to existing or suggests new, standards, methods and procedures.

Execute tests, document & analyze test data, write protocols, procedures, equipment work instructions, test instructions.

The QC Analyst I - is an entry-level role in the analytical Quality Control responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, to clearly document activities performed during testing and to calculate and report results on applicable specification documents.

The Quality Assurance Specialist I will be responsible for the oversight of the Quality Assurance program and the Quality Management System at the site level.

The Quality Assurance Engineer develops, applies, revises, and maintains quality metrics to support areas of operations at Vivex Biologics, Inc. The role assists in the planning, development, implementation, communication, and maintenance of Vivex’s quality management systems, polices, documentation, data, and customer requirements. The Quality Assurance Engineer is expected to work with all departments to ensure compliance, that the final products are safe, reliable, and effective, and the successful and timely completion of projects. The Quality Assurance Engineer is mainly responsible for the maintenance of CAPA system items. They play a key role in preventing issues or fixing them if they arise by defining, monitoring, and approving the processes needed to achieve production standards.

The IC/QC & Distribution Coordinator I - Weekend Shift is responsible for maintaining a high level of inventory accuracy and integrity within the Tissue Bank. Ensure that Inventory Control Operations are in Compliance with the State and Federal Regulations and AATB Standards. Promotes Lean Behaviors across the organization (This includes Participating in Try storming, Brainstorming and Lean Related Initiatives). Resourceful in completing deadlines and can multitask effectively.

You are experienced in software development for scientific data and scientific equipment, and developing algorithms, software, and interfaces. You are conscientious and pay almost obsessive attention to detail, as organized documentation is second nature. You are curious, love learning, and are eager to take on hard problems. You thrive in a fast-paced environment and enjoy pushing the edge of what is possible. You are resourceful and like to work independently but are not shy to ask for advice. You are a cross-disciplinary team member, who is excited to work with and learn from other engineers, biologists, chemists, modelers, and experimentalists. You are comfortable communicating across teams. You deliver. You know that what matters is delivering a solution that works every time.

Akron Biotech is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated professionals to join our expanding team. This is an exciting opportunity to play a critical role within our organization that is driving advanced therapy development and commercialization with high quality industrial scale solutions. We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates.

The Research Associate II will support research programs developing methods to optimize the anti-tumor activity of tumor-infiltrating lymphocytes (TILs) for therapeutic applications. A successful candidate will have experience with aseptic cell culture techniques and cell-based immunological assays. Prior experience with processing blood and solid tissue samples, as well as isolation and ex vivo manipulation of T cells and other relevant immune cells is beneficial. This role is a lab-based and will report to Iovance’s Tampa, FL facility.

The Research and Innovation (R&I) department will be focused on supporting efforts to grow the Digestive Health Enteral Feeding medical device business. This role requires a professional with entry level experience in Research and Development or New Product Development to deliver on the product development roadmap growing Avanos’ enteral feeding business. This candidate must support technical teams for design, development and implementation of changes and improvements to existing products within Avanos’ Digestive Health Business.

TE Connectivity’s Field Application Engineering Teams work intimately with customers to recommend products and solutions for new and existing applications. They identify new applications, requirement modifications and enhancements to meet customer specifications and conduct on-site installation and service of product and are responsible for all technical aspects of the sales cycle for potential application of company products to meet customer needs, including identifying opportunities; determining solutions; creating demand; preparing detailed product specifications and technical marketing support; ensuring high quality and timely project execution and conducting follow-up technical support. They also approve operational quality of systems and equipment.

The Opto-Mechanical Engineer designs, models, analyzes, and tests optical, electro-optical, and opto-mechanical systems and components, including sensors, lasers, fiber-optics, and telecommunications products. Conducts research and development into phases of physical optics and geometric optics, lasers, laser characteristics, laser maintenance, and broadband optical sources. Applies research of complex optical systems to achieve desired optical outcomes. Develops component specifications, tolerances, simulations and tests procedures for electro-optical systems and components. Uses design-to-cost models, six sigma methodology, and other methods to assure and verify optical design requirements are met.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As an Sr. Mechanical Engineer supporting the U.S. Development of Process and Piot Engineering Team in Duluth, GA, a typical day will include: Development, design, installation, commissioning, qualification and validation of new equipment, Communication and coordination with internal/external vendors during the implementation, commissioning, FAT and SAT, Provides expert level support and works with the various internal/external vendors/customers on key systems/deliverables, Collaborates and partners with associates from multiple disciplines, including Process Development, Research and Production, to ensure project success, Provides support, as needed, and generates required technical documentation including standard operating procedures (SOPs), training manuals and validation protocols in accordance with GMP guidelines, Identify, design and implement improvements to machines and processes related to support of contact lens development / manufacturing, Troubleshoot and correct issues related to complex production equipment used in the contact lens development / manufacturing process, Design and execute protocols for product development, and prepare documentation related to procedures, training, work instructions, validations, reports, etc., Support maintenance plans/spare part infrastructure to ensure that the required spare parts are available to reduce machine down times

Leidos is seeking an Associate Distribution Engineer in our Honolulu, HI office. The selected candidate will be required to work for a Leidos contractor for a period of 6 months with the possibility of converting to full-time direct Leidos employment. The successful candidate will have an interest in developing construction work packages for the electric distribution system using various software systems and construction standards. Distribution systems may be in an OH, UG, or URD environment. Project work may include grid hardening and reliability, substation optimization, joint use make ready and street light projects. Work packages will be developed using Geographic Information Systems (GIS), Computer Aided Design (CAD) tools, Work Management Systems (WMS), and other client systems. Project work will require performing engineering calculations that may include: structural analysis of poles, guying, cable pulling, electric demand, fault currents, and coordination of protective devices. Assignments may also include: preparing forestry trimming requests, facilitating permit and Right-of-Way acquisition, development of a BOM, estimating costs, and customer advocacy such as acquiring easements.

This position is part of the Quality Assurance Department located in Coralville, IA and will be on-site. At IDT, we are one global team. We celebrate our differences, engage in healthy debate, and are inclusive. Together, we accomplish great things. In this role, you will have the opportunity to: Contribute to the continuous improvement of product safety +compliance by effectively managing and resolving quality complaints. Communicate with internal team members and external customers to facilitate complaint investigation process. Receive and document complaints from various sources, including customers, healthcare professionals, and internal stakeholders. Work closely with cross-functional teams, including Scientific Application Support (SAS), Quality Assurance, Regulatory Affairs, Product Development, and manufacturing to investigate and resolve complaints. Support quality system investigations, including issue reviews, nonconformances, CAPAs, SCARs, as needed.

This position is part of the Applied Sciences for Therapeutic Oligonucleotides team in our Gene Writing and Editing Business Unit located in Coralville, Iowa and will be on-site. At IDT, we are one global team. We celebrate our differences, engage in healthy debate, and are inclusive. Together, we accomplish great things! Function as a scientist at the bench, under minimal supervision, reporting to a team or project lead and executing projects as part of IDT’s new Genomics Medicine Service offerings related to: off-target safety assessment for CRISPR-based editing systems, CRISPR guide RNA sequencing, and additional, custom projects associated with IDT’s Therapeutic Oligonucleotides business. Provide teamwide scientific support on all aspects of therapeutic oligonucleotides projects inclusive of lab work, project tracking and organization, data collection, data analysis, report generation, and data presentation. Plan and keep detailed experimental records in facilitating technology transfer of methods from R&D to the Gen Meds Services team; gain expertise in technologies to support further feasibility, development and validation of assays as well as propose ideas for broader use and application. Lend subject matter expertise to customer-specific oligo assessment of quality, performance, safety, etc. in cell-based, biochemical or analytical assays; assist in the definition of technical and experimental work plans related to on-going efforts to advance customer projects while supporting customer progress towards cGMP oligonucleotide synthesis.

The Research Associate/Engineer - In Vitro Stem Cells will play a key role in advancing Dimension Inx’s core platform technology and will work closely with the R&D and product development teams to conduct stem cell culture, in vitro testing, and biological assays to support new therapeutic product development to improve patient lives. The ideal candidate is a technically focused scientist or engineer with a background in cell biology, biomedical engineering, or related field, thrives in a rapidly changing, fast-paced environment, and has experience working on multiple and varied projects simultaneously. This position will report directly to a senior R&D team member. This role will contribute to the progression of collaborative early-stage R&D projects, the testing and development of new biomaterial and biological products, as well as various new product development projects.

The Project Engineer - Materials will play a key role in advancing Dimension Inx’s core platform technology and will work closely with the R&D and product development teams to design, iterate, test, and produce materials for novel therapeutic products to improve patient lives. The ideal candidate is a technically focused engineer with a background in materials science or biomaterials, and thrives in a rapidly changing, fast-paced environment, and has experience working on multiple and varied projects simultaneously. The Project Engineer will report directly to the Lead Project Engineer. This role will contribute to the progression of collaborative early-stage R&D projects, the testing and development of new biomaterial and biological products, as well as various new product development projects.

Work within a cutting-edge genomics workflow to provide quality control support in a high-volume clinical molecular laboratory. Help create and implement new equipment functionality for use by Tempus R&D and clinical lab staff while maintaining CLIA/CAP/NYS-DOH/ISO compliance. Test and document new lots of reagents for clinical lab team processing and label reagents approved for use. Maintain reagent qualification records and manage quality control of reagent inventory. Collect and help analyze metrics. Complete Performance Qualifications (PQs), Preventive Maintenance (PM), relocation, and routine maintenance for all clinically approved molecular laboratory equipment. Investigate issues and help facilitate and implement corrective and preventative actions.

Work with a cutting-edge genomics workflow to provide high-quality next-generation sequencing data with rapid turnaround times in a clinical laboratory. Perform routine testing, quality control, calibration, maintenance and proficiency testing in accordance with current laboratory procedures. Perform complex molecular-based procedures with a high degree of quality and in accordance with established protocols. Perform next-generation sequencing, including nucleic acid extraction, DNA/RNA quantification and qualification, NGS library preparation, probe hybridization, probe/library capture, library cleanup and quantification, loading sequencing libraries onto the Illumina Nextseq, HiSeq4000, and Novaseq. Sterilizing laboratory equipment and workspaces as assigned. Entering clinical patient data into the Laboratory Information Management system. Obtain 12 continuing education hours in the field of oncology or molecular biology. Maintain competency to perform all assigned molecular biology protocols in accordance with CAP, CLIA, NYSDOH regulations.

Work with a cutting-edge genomics workflow to provide high-quality next-generation sequencing data with rapid turnaround times in a clinical laboratory. Perform routine testing, quality control, calibration, maintenance and proficiency testing in accordance with current laboratory procedures. Perform complex molecular-based procedures with a high degree of quality and in accordance with established protocols. Perform next-generation sequencing, including nucleic acid extraction, DNA/RNA quantification and qualification, NGS library preparation, probe hybridization, probe/library capture, library cleanup and quantification, loading sequencing libraries onto the Illumina Nextseq, HiSeq4000, and Novaseq. Sterilizing laboratory equipment and workspaces as assigned. Entering clinical patient data into the Laboratory Information Management system. Obtain 12 continuing education hours in the field of oncology or molecular biology. Maintain competency to perform all assigned molecular biology protocols in accordance with CAP, CLIA, NYSDOH regulations.

The Quality Assurance Specialist I will be responsible for the oversight of the Quality Assurance program and the Quality Management System at the site level.

The Microbiologist I works independently on assigned Microbiological projects and conducts analyses of raw materials, finished products, and waters. As a professional scientist, the Microbiologist is expected to work under the guidance of supervisors and managers, develop skills and understanding of laboratory procedures, exhibit technical expertise, be able to document data and report findings; and stay current with Microbiological literature and standards for analyses. You will also conduct analyses of samples in accordance with USP, EP, ASTM, AOAC, FDA, EPA procedures, procedures supplied by the client, and other non-routine procedures as encountered.

The Manufacturing Engineer uses knowledge and technical expertise in support of daily operations within aseptic filling by defining, measuring, analyzing, coordinating, implementing and follow-up concerning projects and activities designed to increase or improve safety, quality, productivity, and/or capacity, all under guidance of Sr. Engineers or Production Management. Applies accepted engineering practices and project management techniques to assigned daily tasks and projects. Analyse situations, break them down into key components and milestones, conduct fact-finding missions, provide detailed plans of action, and implement plans as assigned.

The Scientist, Analytical Development conducts all aspects of Analytical Development including method development, experimentation, and record keeping. The incumbent must be able to develop and implement methods that meet project needs. The position is responsible for conducting analytical development studies with increasing complexity in nature and solving problems to ensure a robust method can be performed in the laboratory.

Troubleshooting advanced technical support issues in the field that are escalated by the customer support team. This will include the intake, investigation, documentation, and resolution of complaints and other field issues.

For the Associate Scientist II position, we are seeking a highly motivated candidate who can independently generate precise, reliable and reproducible data in a timely manner. Can demonstrate experimental precision and strong data interpretation skills. He/she should possess understanding of core discipline and support early phase development of New Chemical Entities (NCEs) drug substance and drug product in both preclinical and clinical programs. Collaborate within the global Analytical R&D organization and with R&D cross-functional partners such as Pre-Clinical Safety (PCS), Process Chemistry, Process Engineering, Drug Product Development (DPD), and Quality Assurance (QA) and CMC-Regulatory. 

This position will work to continuously improve processes and systems that ultimately lead to improved profitability to the company. Using all available Engineering, Lean, and Six Sigma tools, this position will work independently and cross-functionally to drive out waste and reduce process variability.

As the Sr. Electrical Engineer, you will develop creative solutions to challenging problems associated with the design of our new and existing infusion system product portfolio. You will possess strong technical capabilities, an excitement and energy for product development, and a passion for their work and the impact it has on saving and sustaining the lives of patients.

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.

Senior Engineer, Sustaining, will perform activities related to sustaining commercially available products. These activities may include (but are not limited to) product/process remediation, risk analysis, regulatory approval support, and product/process improvements. The Senior Engineer works independently with limited supervision on complex activities and projects. The Senior Engineer acts as a mentor and leader in the department and may review/approve the work of less experienced engineers and/or contractors. This is a Global Sustaining Engineering position.

INCOG BioPharma is seeking a highly motivated individual with subject matter expert (SME) capabilities in sterile pharmaceutical manufacturing process controls and industrial automation. The Manufacturing Specialist is a key technical role within INCOG BioPharma Operations. The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, or within highly regulated industries. The Manufacturing Specialist’s primary responsibility is to efficiently and safely setup and operate various pieces of production equipment within the facility. They will be expected to work hands-on, be actively involved in continuous process improvements while taking ownership of the quality and quantity of product produced. The ideal candidate should possess a strong mechanical aptitude with strong trouble shooting skills on manufacturing equipment. They should demonstrate mentor and leadership skills to motivate manufacturing personnel, drive timely production activities and inspire problem solving & solution driven thinking.

The Manufacturing Science and Technology Engineer will be responsible for supporting all facets of tech transfer, process validation, GMP floor support, and continued process verification in accordance with current good manufacturing (cGMP) for clinical and commercial programs. This role will provide strong technical oversight to the business to ensure robust and reliable production processes are established.   The MSAT Engineer is responsible for scaling up and transferring processes into full scale manufacturing process based on data generated internally or received from the client. 

The primary responsibility of the Manufacturing Specialist in Formulation is to weigh/dispense, setup/operate equipment to produce the bulk drug product for sterile manufacturing. They will be expected to work hands-on, be actively involved in continuous process improvements while taking ownership of the quality and quantity of product produced. The ideal candidate should demonstrate mentor and leadership skills to motivate manufacturing personnel, drive timely production activities and work effectively with internal partners, clients, and vendors.

Your work will contribute to improving the lives and wellness of both people and animals around the world. In this position you will be conducting Animal Research studies that will be looking at the safety, effectiveness and toxicity of drugs that are in early development phase and/or chemical substances. You’ll be maintaining the highest standards of animal care and welfare in accordance with Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). Some of the most common tasks include performing various dosing techniques, may perform bleeding techniques, may collect biological samples, basic measurements such as body weight, food consumption, body temperature, blood pressure, etc. In this position your work will play a key role in bringing new scientific discoveries to life and make a difference in the lives of millions!

We are looking for someone with high emotional intelligence and is comfortable working closely across the team to join us in facilitating the production of viral vectors. The Laboratory Associate I/II will be needed to perform analytical assays for viral vector process development, assist with method development, document experiments, help with lab maintenance and execute assay qualifications. This position calls for an independent thinker who can work seamlessly in a matrixed environment.

We are seeking a Laboratory Assistant to join IQVIA Laboratories at Indianapolis, IN. We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development. The Laboratory Assistant is responsible for performing a variety of routine testing procedures to obtain data for use in clinical trials research.

We are seeking a Laboratory Associate to join IQVIA Laboratories at Indianapolis, IN. We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development. As a Laboratory Associate, you will be responsible for performing routine analysis and laboratory testing procedures to ensure compliance with regulatory standards.

We are seeking highly motivated professionals with experience in developing and commercializing parenteral drug product through various stages of clinical development. If you are interested in building platforms for new and novel therapeutic modalities and interested in building and leading a strong group of scientists exploring new frontiers into formulation and drug delivery strategies, you should consider joining our diverse team.

Production Technicians play an active role in daily production of Radioligand Therapies (RLT) as well as setup and preparation of instruments and equipment. The Production Technician adheres to regulatory requirements while performing job functions, executing production as per batch records and SOPs. Responsibilities are performed within a team and according to an assigned production shift schedule. The Production Technician works closely with the Manager and Lead to ensure production is executed in a safe and timely manner.

The Senior/Principal Scientist - QC is part of the Lilly Lebanon API Quality Control team and provides technical leadership and expertise in the development, implementation, and maintenance of Quality Control laboratory systems to the Lilly Lebanon API site throughout the start-up, implementation, and day to day operations. The Senior/Principal - QC performs accurate and timely testing of routine and some non-routine lab samples in accordance with appropriate GMP and safety guidelines. The Scientist completes second person verification of other’s results. The Scientist also participates in laboratory root cause investigations, equipment evaluations and qualifications, and some quality system improvement initiatives by executing well-defined protocols and procedures. The Scientist shares technical information and best practice within plant sites or group. In addition, the Senior/Principal - QC will provide technical support to QC operations as part of the organization’s off-hours support strategy. After onboarding, this role will require a Short-Term Assignment (STA) of up to 6 months at a Lilly manufacturing site outside of the United States.

The Scientist-QC is part of the Lilly Lebanon API Quality Control team and provides technical leadership and expertise in the development, implementation, and maintenance of Quality Control laboratory systems to the Lilly Lebanon API site throughout the start-up, implementation, and day to day operations. The Scientist-QC performs accurate and timely testing of routine and some non-routine lab samples in accordance with appropriate GMP and safety guidelines. The Scientist completes second person verification of other’s results. The Scientist also participates in laboratory root cause investigations, equipment evaluations and qualifications, and some quality system improvement initiatives by executing well-defined protocols and procedures. The Scientist shares technical information and best practice within plant sites or group. In addition, the Scientist-QC will provide technical support to QC operations as part of the organization’s off-hours support strategy.

Analyzes and designs work systems in order to support general adherence to agreed standards, in order to ensure humanely and economical production and drives continuous improvement topics. This is a preparative organic chemistry synthesis position at the Siemens Healthcare Diagnostics Mishawaka, Indiana facility; Organic Chemistry Group (OCG). The position requires 70% lab/bench work and 30% office/documentation. ‘Work from home’ is NOT an option for this position. The normal work week is 40 hours. However, additional time may be required to meet specific product delivery and chemistry demands.

eGenesis is seeking an innovative Quality Control Technician to provide day to day technical support of eGenesis’ environmental monitoring program. In this position you will be responsible for hands on environmental monitoring sampling, testing, reporting and trending of eGenesis’ GMP manufacturing facility (Norwest Indiana). You will ensure activities are executed in a cGMP compliant manner and will work collaboratively on support of our contamination control program. The ideal candidate will be independently motivated, a strong communicator and demonstrate proficiency in regulatory compliance. This position will be an onsite position in Northwest, IN.

The NPI (New Product Introduction) Engineer will be responsible for ensuring that our innovative designs are transitioned into effective and sustainable production. Our life saving products are manufactured in Kansas City and require predictable delivery of high quality, cost-effective production over 5+ year product lifetimes. You will collaborate with Vantage MedTech’s Engineering and Manufacturing teams to provide input on the device design’s manufacturability, and plan and execute the transfer of these new products to our manufacturing facility. You will be responsible for ensuring that robust manufacturing processes are created, updated and in compliance with company standards, ISO, and GMP as required. In addition, you will help drive improvement projects that impact quality and productivity.

The Capital Engineering Process Engineer is a key technical role responsible for providing engineering and process equipment expertise for the execution of Capital projects at the McPherson site. The role requires a high level of technical expertise in pharmaceutical processing systems, formulation equipment, high purity piping distribution systems, aseptic filling operations, terminal sterilization processes, inspection / packaging equipment, and clean room facilities design requirements. The incumbent will provide focused process ownership and the technical expertise to ensure high quality and efficient sterile injectable products. As technical lead, the Capital Engineering Process Engineer partners with supervision and production colleagues to identify and implement innovative solutions. This role focuses on developing new processes on site, resolving engineering issues, and providing technical support and troubleshooting during all phases of the Capital project. The Capital Engineering Process Engineer supports the Capital Portfolio Manager in the execution of assigned projects, which may include the coordination of internal company resources and vendors as part of the execution of projects.

Cambridge Isotope Laboratories, Inc. (CIL) is searching for a Senior Chemist I based onsite in our Andover, MA facility. CIL is the global leading company in a highly technical, extremely fast-growing industry and is a critical supplier to several scientific and high technology markets. CIL's growing customer base spans academia, pharmaceutical, medical diagnostic and semiconductor industries enabling collaborations with Nobel laureates, industry-leading scientists, and chemists. CIL partners with leading instrument manufacturers as well pioneering research groups that have expertise in product development and drive market growth. CIL is a subsidiary of the Otsuka Pharmaceutical Group and has had consistent growth for over 40 years. The Senior Chemist I will be responsible for the de novo synthesis, route development, and final product characterization of a wide variety of complex isotopically labeled targets (13C, 15N, 18O, and D isotopes). This role demands the production of high-quality, finished products in accordance with established specifications, while adhering to CIL’s safety and general policies. The Senior Chemist I will operate with a high degree of autonomy, ensuring that production requirements for safety, yield, time, and quality are consistently met.

You will support the execution of production according to Standard Operating Procedures and production schedule. Working with interdisciplinary teams, you will implement process improvements and participate in process troubleshooting. As part of technical operations, you will be developing and applying your knowledge of procedures, techniques, tools, materials and equipment. Your receptiveness to new ideas will enhance the team’s ability to achieve goals and targets. You will follow standard procedures to complete tasks and identify process issues or problems that involve direct application of your skills/knowledge. It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

We’re looking for a highly motivated scientist with experience in primary human cell culture, molecular analytics, and cell-based assays to work with our Analytical Development Core Testing team. You’ll focus on characterizing engineered cell therapy products and supporting Obsidian’s tumor infiltrating lymphocytes (TIL), viral vector and critical materials analytical teams. You’ll support critical studies and experiments to advance Obsidian OBX-115 product understanding and work with various subject matter experts across different functional groups, affording a significant learning opportunity and career development. This position is a six month contract role.

The Associate Manufacturing Engineer will primarily be focused on creating and implementing process improvements and strategies to optimize manufacturing efficiency. This includes sustaining, continuous improvement, and new product introduction efforts to scale with the dynamic workload. They will also be working together with the technician workforce to provide production floor support, as well as being a cross-functional resource to liaison between operations and other engineering teams to ensure communication and compliance across all facets of manufacturing.

The Lab Technician II - Buffer Prep position is primarily responsible for following standard operating procedures, with increasingly limited supervision and also as part of a team, to provide high quality chemical solutions, highly responsive service, and to perform a wide variety of basic laboratory tasks in support of CST's Production, Development, and Research laboratories.

Provides support for new product formulation, aseptic & topical process development, process transfers and troubleshooting existing manufacturing processes.

The Quality Design and Reliability Assurance (DRA) Engineer II is responsible for the efficient and compliant support of New Product Development (NPD) and Sustaining/Remediation project(s) of varying scope and complexity in the Tissue Technology (TT) division, specifically the Boston/ Braintree site. The role contributes and supports the design and development of new and improved products. The (DRA) Engineer II will interact with external design and development partners, participating on cross-functional project teams through all phases of the product development process, and assisting the technical team with planning, executing, documenting, and communicating testing activities. The role works with Product Development, Project Management, Regulatory, Marketing and Medical Affairs.

Jnana Therapeutics is seeking an enthusiastic, highly motivated Research Associate to join our multidisciplinary team. This position offers the opportunity to contribute across Chemical Biology and Compound Management, supporting cutting-edge drug discovery efforts to unlock challenging targets using our novel hit generation platform and a variety of high-throughput, cell-based, and biochemical assays. This is an excellent opportunity for someone excited to grow their career in biotech, gaining exposure to both experimental science and core infrastructure that drives early discovery.

As a Sr. Research Assistant or Associate Scientist on the Screening, Biophysics, and Biochemistry team at Magnet Biomedicine, you will play a critical role in designing, executing, and interpreting biophysical and biochemical assays to discover and characterize small molecule chemical inducers of protein-protein interactions. This position offers a unique opportunity to contribute to the development of Magnet’s platform and the development of next-generation TrueGlue therapeutics. The successful candidate will collaborate with a team of passionate scientists to achieve our goal of bringing new medicines to patients.

The Global Biologics Biological Generation and Analytics team seeks an enthusiastic, energetic, and team-oriented individual to join us. The position involves contributing to the team by identifying binding interactions through various techniques and independently analyzing data. Responsibilities include designing and executing experiments, troubleshooting as needed, and actively participating in program teams to develop analytical strategies. Effective communication skills and the ability to work within cross-functional teams are essential.

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Research Senior Associate, Oncology Drug Discovery Unit in our Cambridge office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Biogen is seeking a highly motivated scientist to join the Drug Metabolism and Pharmacokinetics (DMPK) department at our Kendall Square site in Cambridge, Massachusetts. The role requires hands-on experience in conducting in-vivo studies in rodents, and basic familiarity with the concepts of pharmacokinetics (PK). The ideal candidate will not only conduct PK studies in nonclinical models but will also conduct animal surgeries when necessary.

FL106 is seeking a highly motivated (Senior) Research Associate with expertise in Cell and Molecular Biology to play a vital role in the company’s efforts to validate novel target discovery approaches. The candidate must be independent, goal oriented, have excellent communication skills and be willing to work in a highly dynamic and fast-paced entrepreneurial environment. This is a unique opportunity to drive the growth of an early-stage biotechnology company where you can contribute to the next frontier of genetic medicines. We are looking for collaborative, enthusiastic problem-solvers to join our team, driven by a shared goal of making a practical impact.

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. As a Associate Scientist - Medicinal Chemistry, Integrated Drug Discovery, your skills could be critical in helping our teams accelerate progress. Synthetic organic chemist with deep knowledge of organic chemistry principles and modern synthesis methods to design and execute efficient synthetic routes for target compounds and the progression of drug discovery projects.

We are looking for Research Associate (RA-I or RA-II) with an innovative mindset, great attention to detail and ability to work collaboratively to solve problems, to help advance therapeutic candidates to the clinic. The successful candidate will have an opportunity to positively impact patients with serious unmet medical needs while working closely with our world-class scientific team, including with company’s scientific co-founders In this position, you will collaborate with the in vivo pharmacology team to study effects of therapeutic lead candidates. The RA will work with animal models for rare genetic diseases and will be responsible for executing experiments to quantify molecular, cellular, and physiological readouts, in addition to supporting in vivo dosing studies and related research activities within the in vivo pharmacology group. This is an exciting opportunity for a motivated scientist to further develop their skills in neuroscience, physiology and gene therapy while helping to make an impact on lives of patients suffering from rare diseases.

Responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.

The Engineering department is primarily responsible for the detailed design, startup, troubleshooting, commissioning, optimization and lifecycle support of manufacturing equipment, facilities, and utility systems.

The Analyst II, QC Microbiology position supports the Quality Control group at Bora Pharmaceuticals Camden Campus to maintain process optimization and manufacturing activities. The Microbiologist is responsible for performing activities in support of the Microbiology, Environmental Monitoring, and Utility testing programs, which includes microbiological product testing, monitoring of the manufacturing production space, and supporting quality initiatives. The individual routinely conducts monitoring, testing, and SOP generation and revision.

Responsible for conducting qualitative and quantitative microbial analyses in support of environmental monitoring, cGMP manufacturing and stability of drug products and incoming raw materials. This position supports our 2nd-shift, working 2pm-10:30m, Monday through Friday.

We seek an enthusiastic and curious scientist interested in participating in all aspects of the hit-to-lead drug discovery process. The opening is at our state-of-the-art facility in Canton, MA. The successful candidate will engage in the company’s virology research areas and work with a successful team of scientists in the USA and EU. The ideal candidate will have great communication skills, excellent technical skills, exemplary attention to detail, and a passion for learning. This position will have the opportunity to make significant scientific contributions to numerous drug discovery projects.

LFB USA has an immediate need in our Manufacturing group for a Manufacturing Technician. Level will be based upon experience. Responsible for the commercial production of drug intermediates (protein purification, buffer/equipment preparation), intended for further manufacture of drug products. This is a senior technician position in a regulated biomanufacturing setting.

Performs chemical and/or biological assays of commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with current Good Manufacturing Practices, Associates of Cape Cod Standard Operating Procedures, compliance guidelines of the FDA and other regulatory bodies, and approved license requirements. Learns and executes defined QC tasks efficiently and consistently. Results are compared to specifications and documented in a timely manner. Analyst has working knowledge of relevant QC techniques, policies and procedures to perform QC tasks and document results. Analyst receives minimal supervision on routine assignments and detailed instructions on new assignments.

We are seeking an Entry Level Civil/Structural Engineer with 0-2+ years of experience with a utility and/or utility consulting company doing design engineering. The candidate must have a strong educational background in design of steel structures, concrete structures, geotechnical engineering, and foundations.

The Technical Operations Engineer I/II will be responsible for providing drug substance and/or drug product technical support for oncolytic virus manufacturing. This includes life cycle management of commercial processes, including ownership and support of change controls, CAPAs and deviations.

The Manufacturing Specialist I and II will be part of a cohesive team responsible for producing RPX at Replimune’s Framingham Manufacturing Facility. The Manufacturing Specialist uses expert knowledge of cGMP regulations and biopharmaceutical production processes to provide day to day operational support through the implementation of process improvements, leading manufacturing activities, supporting the scheduling of daily manufacturing activities and deviation/CAPA/change control writing with a focus on but not limited to Commercial/Clinical Manufacturing.

We are seeking a scientist with strong organizational skills, excellent oral and written communication, and keen attention to detail. The ideal candidate will support the development, optimization, and qualification of analytical methods in a compliance-based environment. This role involves method development, process support, documentation, and potential technology transfer, along with some analytical testing. The ability to work independently and collaboratively, along with self-motivation, adaptability, and a positive attitude, is essential.

This position is primarily responsible for developing and implementing robust cost-effective manufacturing processes and methods in accordance with product specifications within thin film fabrications. This position recommends and implements improvements to sustained production processes, methods and controls; as well as coordinates the launch of new products into pilot production.

Akoya is seeking a Research Associate II (RA-II) to work within our Akoya Advanced Biopharma Solutions (ABS) CLIA laboratory located in Marlborough, MA. This position is a full-time onsite role. The candidate will have worked in a clinical or preclinical pathology laboratory with experience in high-throughput histology with focus on immunohistochemistry. The candidate will work with lab personnel on histology processes such as grossing, processing, embedding, and microtomy. Knowledge of antibody validation methods, immunofluorescence (IF) and quantitative pathology approaches are a plus but not required. The successful candidate must have significant experience in microtomy, preferably with rotary microtomes. They should also be familiar with LIMS systems and have experience working in a regulated laboratory setting such as CAP/CLIA and GCLP.

The Chemical Compliance Quality Specialist is responsible for developing, implementing, and maintaining Quality Management System (QMS) procedures and work instructions related to chemical compliance within the division. This role serves as a liaison between the Corporate Chemical Compliance group and the division, ensuring regulatory and QMS changes are assessed and implemented. The specialist leads the quarterly Chemical Compliance review process, monitors Key Process Indicators (KPIs), and supports product development and engineering teams as a Subject Matter Expert. Additionally, this position involves assessing product compliance, reviewing engineering changes, conducting production record reviews, and performing investigations.

Meadowhawk Biolabs is seeking a highly motivated and dynamic Research Associate to work within the Discovery Bioanalytical Team at our Marlborough, MA location to perform LC-MS/MS assays in a fast-paced team environment. The ideal candidate is driven, hardworking, willing to learn, dedicated, and passionate about science. Given that we are a newly launched Contract Research Organization (CRO) founded by an experienced team of industry veterans, this ground floor position offers unique opportunities for the successful candidate to contribute meaningfully to the creation and development of our services, expand their knowledge base by participation in multidisciplinary teams, and advance their career in capabilities and responsibilities.

We are currently seeking a QA Associate I to join our Quality team in Marlborough, supporting Hollow Fiber and Single Use ATF Manufacturing. The QA Associate I will actively participate in the Repligen ISO 9001 Quality Management System, reviewing production records and releasing product, as well as supporting other QA team members and areas of work, as needed. The successful candidate will have a positive attitude and be able to communicate effectively. This candidate will be responsible for assisting the QA department to revise/create, file, organize, and review production documents. The candidate will work closely with the manufacturing teams to ensure accuracy of production documentation throughout the production process. This position involves completing the QA review of production records, including but not limited to; verification of raw materials used, verification of calculations, good documentation practices, and processing steps have been completed according to the internal processes.

The Manufacturing Associate provides direct labor for the manufacturing of high-quality diagnostic products using manual and semi-automated equipment and prepares/completes required documentation on manufacturing procedures. This position is responsible for set-up, calibration, and operation of all manufacturing equipment in accordance with cGMP, POPs, SOPs, Safety, and departmental policies. This position utilizes good judgment and critical thinking skills to make operator level decisions regarding the quality of the products manufactured.

The Manufacturing Associate II provides direct labor for the manufacturing of high-quality diagnostic products using manual and semi-automated equipment and prepares/completes required documentation on manufacturing procedures. This position is responsible for set-up, calibration, and operation of all manufacturing equipment in accordance with cGMP, POPs, SOPs, Safety, and departmental policies. This position utilizes good judgment and critical thinking skills to make operator level decisions regarding the quality of the products manufactured.

The Imaging Specialist is responsible for performing Quality Control functions on all cases and taking digital microphotographs on designated cases for final pathology report. The Imaging Specialist will follow the direction of the supervisor while taking initiative in performing and promoting quality and efficiency within the department. The Imaging Specialist will be trained in the expected task in order to meet the competency set by the department.

Responsible for ensuring materials, processes, and products meet the required specifications, which involves, but is not limited to, inspections, metrology testing, documentation, and labeling reviews. Product acceptance or rejection. Responsible for maintaining equipment calibration.

The QC Analyst I, Cell Culture performs quality activities in support of product production and release for ASA Product. This position interacts with other internal departments, including Production, Quality Assurance, Validation, Calibration, Materials, and Logistics. The position also interacts with external entities including contractors and suppliers. The QC Analyst I performs a variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results.

Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. Our Quality Assurance Specialists are leading service providers to our clients providing GMP support. The individual will coordinate validation activities with the client and meet timelines.

Tessera Therapeutics is looking a Research Associate to support upstream processes for Oligonucleotide manufacturing, research and scale -up. You are interested in gaining a deep understanding of organic synthesis techniques and finding efficient ways to synthesize long oligonucleotide. You are comfortable multitasking in a fast paced environment under supervision with support of your team on various aspects of the platform. You are an independent, creative thinker with high attention to detail and are enthusiastic about contributing to new ideas.

A Research Associate I is an entry level position for Bachelor’s degree with no prior experience and reports to a scientist level or above on relevant projects. The individual is responsible for routinely setting up, operating, and maintaining the downstream lab equipment under direct supervision at BIB.

The Healthcare Compliance Associate will report to the Director of Healthcare Compliance on the Compliance Monitoring and Auditing Plan. This position will require extensive domestic travel and will play an important role in fostering a culture of compliance.

Would you like to apply your expertise to impact drug development in a company that follows the science and turns ideas into life-changing medicines? Then employment at AstraZeneca might be the right choice for you! We are seeking a highly motivated Scientist in Oncology Targeted Discovery with strong scientific and technical expertise in oncology research and a track record of scientific excellence to join our team in Waltham, MA USA. As a Scientist in our Oncology R&D department, you will be a key member of a team focused on supporting oncology projects through the drug discovery and development process. You will bring your theoretical and practical expertise in cancer biology to establish assay systems and deliver datasets that will have a direct impact on targeted therapeutics.

The Laboratory Technologist will be responsible for pre-analytical accessioning, processing, and maintaining inventory of clinical blood samples in accordance with established laboratory procedures. This role ensures the integrity of patient samples, supports downstream users in clinical and research operations, and maintains compliance with laboratory quality and regulatory standards.

As an Associate Quality Engineer, you will work closely with cross-functional teams to support various aspects of quality engineering, with a focus on New Product Introduction and failure analysis. Reporting to the Manager, Quality Engineering, you will assist in implementing and maintaining quality systems and processes to meet regulatory requirements and industry standards.

We are currently seeking a Research Associate to support Trinity’s Evidence, Value, Access, and Pricing (EVAP) teams with research activities spanning several adjacent areas: Payer / HTA and pricing analysis, life science-related landscape research, targeted and systematic literature review, and research relating to value dossier development.

Performs a variety of routine tasks and often complex and difficult procedures independently and under supervision, in support of the conduct of normal laboratory operations. Individual is expected to detect and report problems in standardized procedures due to instrumental, sample, or test system failures. Performs a variety of routine, laboratory-based procedures. Responsible for understanding and routinely performing applicable Standard Operating Procedures, study specific protocol procedures and other laboratory assignments. This often includes recording instrument and apparatus readings on standard forms, preparation of test systems and recording and compiling laboratory data in real time in a complete and thorough manner for individual assignments. Responsible for maintaining cleanliness of the labs, storage and chamber areas as well as executing regular maintenance/calibration of equipment used on a regular basis. Employee is responsible for understanding and adhering to all safety and Good Laboratory Practice regulations as well as company policies. Duties are performed with minimal supervision.

Garuda Therapeutics is seeking a motivated Manufacturing Associate or Senior Manufacturing Associate to support routine GMP Manufacturing operations. This includes day-to-day operational tasks including but not limited to Cell Culture in a clean room environment, GMP Materials Logistics, and Environmental Monitoring within Garuda’s GMP manufacturing space. This is an on-site role, primarily in Watertown, MA with occasional work in Cambridge MA. Some travel between sites is required.

We are seeking an experienced Quality Control Analyst I/II to join Mariana’s Analytical Quality Control function. You will be responsible for supporting the release and stability testing of our clinical therapies produced in our GMP manufacturing suite in Watertown. This person will play a role in creating and maintaining the highest standard of excellence for our therapies to treat cancer patients.

We are seeking a highly motivated and energetic Research Associate, Discovery Peptide Chemistry to join Mariana’s Chemistry organization. The successful candidate will be a contributor to our targeted oncology platform in a pre-clinical, fast-paced discovery research environment through the purification and characterization of peptides. They will also work closely with the Medicinal Chemistry and Biology teams to support our drug discovery portfolio. The role requires the candidate to maintain broad scientific knowledge of high-performance liquid chromatography to execute peptide purification and characterization. The role also requires the candidate to become familiar with peptide synthesis and perform other chemistry tasks to support drug discovery efforts. The candidate should be a creative individual with good communication and interpersonal skills, and a willingness to step outside of their comfort zone.

Responsible to be a Member of the Regulatory team that ensures regulatory approvals are effectively obtained and compliance with regulations is maintained. The specialist may participate in product development teams. Author regulatory submissions and technical files. Organize regulatory information and tracks and controls submissions. Review and advise on labeling for compliance with regulatory filings. Review product changes for impact on regulatory filings worldwide. Research regulatory issues and provides guidance and advice to colleagues. Review product complaints to determine if the events are reportable to regulatory agencies.

The Manufacturing Engineer I will be responsible for the selection, development, qualification, and scale-up of production processes and equipment across different manufacturing departments. Process objectives are the high quality, high volume production of patient-tailored implants and associated instruments.

In this position as an Associate Scientist, you should possess a thorough understanding of laboratory procedures. You will perform a variety of complex sample preparation and analysis procedures to quantitatively measure biopharmaceutical compounds in a variety of biological matrices. Instrumentation is primarily HPLC and CE. Hamilton Liquid Handlers Protein Maker affinity purification is used as well. Requires following analytical procedures with periodic direct supervision. Responsible for review and compilation of results and data comparison against acceptance criteria, methodology, protocol and product specifications. Enters data into databases and reports.

The position as a Quality Engineer will work closely with the Operations and Engineering Teams to ensure that goods and current products are well designed and manufactured to meet or exceed the customer expectations and requirements. This position will support manufacturing production and is responsible for performing corrective actions and driving continuous improvement initiatives. Ensure compliance to Terumos quality policy, respond to customer complaints, perform audits, develop test methods, and/or write procedures for material characterization.

We seek a highly motivated and detail-oriented Laboratory Technician to join our team. The successful candidate will possess a fundamental understanding of current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs), ensuring compliance with industry standards on a daily basis. The role requires proficiency in laboratory operations, sample management, and collaboration across departments.

We are seeking an Associate Scientist to join our Downstream Process Development group in Gaithersburg, MD. Qualified individuals will be responsible for hands-on execution of downstream chromatography and filtration processes in support of process development, scale-up, process characterization activities, and technical support of cGMP manufacturing for proteins, nanoparticles, and virus-like particle (VLP) based vaccines. The candidate will ensure scientifically sound experimental execution, analysis, and reporting. The candidate will be responsible for drafting technical development reports summarizing critical data. The candidate is expected to be highly self-motivated, well organized, and an innovative thinker focused on execution with a sense of urgency. This position will be located at our Gaithersburg, MD facility

Smithers PDS is seeking a Scientist to join our team in Gaithersburg, MD. The Scientist performs data analysis and various assays according to SOP with reliability while applying and meeting GLP, GCP, and/or CLIA requirements. This position assists with ensuring that the lab, materials, and equipment are maintained.

Perform routine molecular biology lab duties such as DNA and RNA extraction, gel electrophoresis, solution and buffer preparation, and etc. Perform and document all test procedures with accuracy, consistency and timeliness in accordance with laboratory SOPs and regulatory guidelines. Assist with the generation and updating of laboratory SOPs. Perform basic lab maintenance tasks such as ordering lab supplies, and keeping detailed lab records. Communicate with clients to obtain/verify information of their projects, orders or requests.

Join MaxCyte as a Software Engineer and be at the forefront of developing cutting-edge instrument software and applications, including intuitive UIs and advanced instrument control layers. You’ll be involved in every stage of the software lifecycle, from initial concept to final commercialization, ensuring our life sciences tools are best-in-class. This role offers a unique opportunity to work on innovative projects that make a real impact in the world of biotechnology. Additionally, as a key member of a high-performing team, you’ll have ample opportunities to learn and grow, staying updated with the latest technologies and industry trends.

In house Clinical Research Associate (In-house CRA) will act as the clinical operations person to participate in IRB and TMF document submissions related to site selection, activation, maintenance, and closeout activities, in site monitoring and compliance management, and data integrity monitoring functions within OncoC4, supporting ongoing and future OncoC4 clinical trials of novel immune therapies for cancers.

Follows standardized procedures and prepares samples for testing. Analyzes test results for accuracy, acceptability, and critical limits. Relies on limited independent judgment to plan and accomplish goals. Performs a variety of tasks. A limited degree of creativity and latitude is required.

We are looking for a Research Engineer or Scientist to work as part of an interdisciplinary team on ocean modeling and exploitation of sensor data in an oceanographic context. This position will be on site in Ann Arbor, MI with flexibility for a hybrid work schedule, 2 days on site and 3 days working from a home office.

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.

The Chemist II, under general supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. Detects, participates and reports on OOS/OOT/NOE and other investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. May train less senior staff.

The Operations Engineer, Sterile Filling, works in a hands-on capacity in a fast-paced, cGMP environment and production support areas to process sterile and aseptic products. The specialist works in collaboration with Operations, Maintenance, Engineering, Supply Chain, Quality Assurance, and Pharmaceutical Technology and Validation for successful repeatable day-to-day manufacturing operations in the Sterile Filling Area. Position is responsible for working with operations team to mitigate gaps within the sterile filling operations. Position also facilitates maintaining departmental documentation and processing of batch documentation. Position is also trained to perform verification of process steps in support of departmental supervision. Knowledge of cGMP’s is essential to successful performance of the position. In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.

The Operations Engineer, Sterile Filling, works in a hands-on capacity in a fast-paced, cGMP environment and production support areas to process sterile and aseptic products. The specialist works in collaboration with Operations, Maintenance, Engineering, Supply Chain, Quality Assurance, and Pharmaceutical Technology and Validation for successful repeatable day-to-day manufacturing operations in the Sterile Filling Area. Position is responsible for working with operations team to mitigate gaps within the sterile filling operations. Position also facilitates maintaining departmental documentation and processing of batch documentation. Position is also trained to perform verification of process steps in support of departmental supervision. Knowledge of cGMP’s is essential to successful performance of the position. In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.

We are seeking an Entry Level Civil/Structural Engineer with 0-2+ years of experience with a utility and/or utility consulting company doing design engineering. The candidate must have a strong educational background in design of steel structures, concrete structures, geotechnical engineering, and foundations.

The QC Chemist position is responsible for independently performing testing in a pharmaceutical Quality Control laboratory. All work will be conducted in accordance with standard operating procedures and test methods. This includes performing testing on raw material, in-process and finished product samples. Execute compendia method validations, method transfers and validation support of new product development. Set up and confirm suitable operation of equipment and instrumentation. Collect data and generate/report results in accordance with governing test methods and SOPs.

Are you seeking a role that supports the delivery of lifesaving devices? Do you enjoy working with cross-functional teams to ensure quality standards are met throughout the production process? Are you interested in a role that Identifies quality issues, recommends solutions, and implements changes to resolve discrepancies? Do you like the rigor of Ensuring that processes adhere to quality standards and regulatory requirements. If any of these resonate with you, we encourage you to explore our Quality Engineer role!

In this exciting role as a Battery Manufacturing Engineer II at Medtronic’s Energy & Component Center (MECC), you will have responsibility for supporting and improving the manufacturing of the high quality batteries used in implantable medical devices. You will be responsible for day to day production support, new process development support and lead improvement projects. The Brooklyn Center facility supports the design, development, and production of components used in implantable devices for a variety of Medtronic businesses. In this role you will gain experience with products across Medtronic’s portfolio, supporting your development and growth. This role is responsible for improving manufacturing quality, lead time and cost through active problem solving, developing solutions and implementing process changes in accordance with the quality system. What does it take to be a leader at Medtronic? We look for inspiring and inclusive leaders who partner with others, knowing that diverse talent, skills, and perspectives lead to better outcomes. Please note this role does work on-site in the manufacturing area.

The position holder is responsible for the execution and documentation of process development deliverables and activities for Single Use Endoscopes (SUE) product development and launch to production. The position holder implements the optimal manufacturing processes according to product delivery, operations, and business requirements to launch products effectively, on time, with high reliability and the right cost. The position holder responsible for proactive engineering responses in alignment with Regulatory compliance requirements.

The Engineer II on the Sustaining Engineering team is responsible for supporting all aspects of Sustaining Engineering efforts, including supporting project definition activities, leading/supporting verification and validation efforts, and overseeing implementation. In particular, it will be the responsibility of the Engineer II to advance technical efforts, while proactively identifying potential issues, to achieve a timely launch of high quality / reliable product. He or she must have a working knowledge medical device design control requirement, be able to technically contribute to the project team, and work collaboratively across the organization to ensure an effective implementation of the improvement, solution, or line extension. As the Engineer II will contribute to Design History Files, maintaining detailed documentation throughout all phases of the project is essential.

As a Development Associate II, you will work with other members of the Technical Operations group to lead tech transfers of products into the facility at bench and pilot scale and subsequently to commercial scale. You will provide manufacturing technical support including batch records, deviations, change controls, investigations, life cycle management, scale down modeling, satellite runs, process validation, data tracking and trending, and supporting CMC regulatory filings. You will report to the Senior Manager of Technical Operations.

The Scientist I Production Operations for Beckman Coulter Diagnostics is responsible for following established operation procedures, maintaining appropriate training records for your role, sustaining a smooth flow of material, and the execution of work orders to on-time completion. This position is part of the Upstream Value Stream located in Chaska, MN, and will be on-site. In Upstream Value Stream, our goal is on-time delivery of cell culture, purifications, and conjugations to support on-time delivery of immunoassays to patients. You will be a part of the Upstream Value Stream focusing on Conjugations. If you thrive in a fast-paced dynamic role and want to work to build a world-class manufacturing organization—read on.

The Electrical Engineer II, under general supervision, are responsible for the design of new products and ensuring that they meet performance, quality, manufacturing, and cost requirements for Standard (Behind the Ear - BTE) and/or Custom (In the Ear - ITE) products. Must possess communication ability, technical expertise, creativity, and internal drive to lead the creation of designs that are recognized as best- in-class in the hearing aid industry. Must be able to work well in a team environment and have a passion for continuous improvement.

Activities include product design and development, defining technical solutions to abstract problems, defining methods and processes, design modeling, tooling design/fabrication, equipment design/fabrication, personnel management, design verification and validation, and documentation. Participate in the day-to-day execution of reliability tasks by teams and team members through monitoring progress, providing technical direction, and problem-solving solutions. Subject matter expert on test method development and design verification. Primarily by driving the testing of device, assist in design and develop innovative products & manage the product design from concept to full production. This position will participate in the execution of development projects as part of a multi-functional project team with an emphasis on the V&V activities.

As a R&D Engineer II, you will support commercial product improvement and supply continuity through design and material changes, product expansions, and complex problem solving. This role involves working collaboratively with cross-functional teams to ensure product designs meet the highest quality and regulatory standards.

This position is responsible for purifying proteins and polyclonal/monoclonal antibodies in a GMP Lab, following GMP guidelines. This includes, but is not limited to GMP, ACFP, natural, and other products used by pharma and IVD customers. Purifies proteins and polyclonal/monoclonal antibodies by column chromatography, using a variety of techniques and equipment. Filter, aliquot, and bottling of product using aseptic techniques, and submits to bulk inventory. Documents batch records following GMP guidelines.

The responsibilities of an Advanced Manufacturing Technician is to assist in the process of formulating buffers, diluents, and other components of Bio-techne’s best in class immunoassay products. Daily work may include recording data, operating equipment, product formulation and plate coating. Collaboration with other groups is also part of our work. Employees must have the ability to work independently and as a part of a team environment. Additionally, able to lift or move >50 lbs. routinely.

This position is responsible for purifying proteins and polyclonal/monoclonal antibodies in a GMP Lab, following GMP guidelines. This includes, but is not limited to GMP, ACFP, natural, and other products used by pharma and IVD customers. Purifies proteins and polyclonal/monoclonal antibodies by column chromatography, using a variety of techniques and equipment. Filter, aliquot, and bottling of product using aseptic techniques, and submits to bulk inventory. Documents batch records following GMP guidelines.

Provides high level technical support to customers on use of hematology products. Answers and documents incoming technical inquiries and complaints by phone and email on product techniques, procedures and troubleshooting. Communicates to obtain all pertinent information relating to the inquiry. Provides adequate information to problem solve or to assist in the resolution of the issue. Documents information and recurring technical issues to support product quality programs and product development. Works on complex problems of diverse nature where analysis requires in-depth evaluation of various factors. Supports the Marketing and Sales Departments. Provides guidance and recommendations on products based on customer needs and utilizes customer interactions to improve business opportunities. Collaborate with cross-functional teams for root cause analysis. Helps to identify gaps and collaborates to devise and implement process improvements. Assure a high level of quality and accuracy in the processing of customer QC data. Provide QC program support for OEMs, International Distributors and end-user customers. Follows company policies and practices as outlined in the Handbook and follows guidelines regarding safety as outlined in the AWAIR, Chemical Hygiene and Exposure Control manuals in accordance to the job.

This position supports the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. This individual will work with supervisors, engineers, technicians, and operators to address problems and opportunities identified on manufacturing lines. He or she will be accountable for quality, safety, product output and yield initiatives, as well as providing line support on a daily basis.

The Field Service Application Scientist I is a multi-disciplinary molecular biology and organic chemistry position that will contribute to the organization as part of our Global Field Service team, bringing curiosity, problem solving skills, and scientific acumen to LGC. The Field Service team supports various wings of the organization such as Laboratory Operations, Engineering, Sales, and Manufacturing.

The Quality Control (QC) Technician performs assigned laboratory testing in compliance with applicable standard operating procedures (SOPs) and in compliance with U.S. and international regulatory requirements, including FDA, ISO, USP, and NRC guidelines. The QC Technician adheres to current good manufacturing practices (cGMP) and good documentation practices (GDocP) for all analyses. Working collaboratively with other laboratory personnel, the QC Technician coordinates instrument usage and completes laboratory tasks efficiently. The QC Technician completes testing and promptly reports any aberrant results to quality management. They work independently under limited supervision and handle radioactive materials as part of their duties.

Are you looking to embark on a new challenge? The possibilities are endless when start your career at Labcorp! We would love to discuss the exciting opportunities you will encounter when you join our team as a Technologist Trainee. In this position, you will work in a patient focused, fast paced, and inspiring environment. You will have a dynamic role in the fulfilment of Labcorp’s overall mission of “Improving Health, Improving Lives.” The MCT Department is looking for a Technologist Trainee to work in our laboratory. The candidate will receive on-the-job training for the pre-analytical through post-analytical set-up and testing of patient samples. This laboratory is responsible for screening blood, serum, urine and meconium sample types for drugs of abuse. We also perform Therapeutic Drug Monitoring (TDM) and STAT testing for local clinics and hospitals. The MCT Laboratory uses immunoassay methodology (Beckman Coulter AU5800 Chemistry analyzers) to test samples. Some assays require a chemical extraction before analysis.

We are seeking a high caliber Development Quality Engineer II. A development quality engineer assures new or iterative products conform to requirements and establish compliance with the quality system. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

Roche Support Network is dedicated to providing exceptional support to customers. As a Field Engineering Specialist you will: Showcase your expertise in technical repair and installation for Roche assigned product lines. Offer valuable service to laboratory customers in your assigned territory. Provide routine technical support, on-site service, repair, and installation of Roche products. Serve as a customer contact for technical and service-related issues and perform preventative maintenance. Diagnose and resolve mechanical, hardware, software, and system failures. Document all activities, contribute to quality improvement, and focus on maximizing customer satisfaction.

Are you looking for your next profession in Preclinical studies? Start your career with Altasciences while working in our new state-of-the-art laboratory! Altasciences has just completed an 8,000-square-foot expansion of our laboratory in Columbia, MO and we are looking for exceptional analysts to join our growing team. You will assist in daily activities and operation of the Laboratory Sciences department including equipment maintenance, stocking supplies and general cleaning. You will also support and perform data collection activities including ligand binding assays, and/or flow cytometry, and/or cell-based assays, and/or mass-spectrometry. We are hiring for all levels of Scientist, so apply today!

Using good aseptic lab practices, is responsible for supporting performance testing and physical inspections of finished good lots as well as internal use only lots through set up of VITEK2 cards, to completion. This position performs environmental testing and ensures proper documentation according to cGMP’s and current procedures, to completion. Performs all duties using safety conscious practices. Technician will uphold the lab attendance policy.

The position will be providing analytical support to biotherapeutic process development teams, specifically focusing on large molecules (proteins, polysaccharides, nucleic acids, etc.). Candidates should have familiarity with several of the below laboratory techniques; they should also possess expertise/knowledge with: Ultraviolet and visual light spectroscopy (UV-Vis), Analytical chromatographic separations using HPLCs or UPLCs, SEC-MALS, Small-volume multichannel pipetting skills and plate-based assays

We are now hiring an NPI QC Bioassay Trainer into our team in Westport for a Fixed Term Contract for 23 months Fixed-Term-Contract. This person will join the Westport Bioassay department and the role centres on providing an efficient training programme to all personnel working in the QC Bioassay labs. The trainer role will be responsible for developing and managing training of all new hires for NPI QC Bioassay and will be responsible for updates to key stakeholders on training timelines to support analyst training completion on time. The trainer role will also include supporting NPI drug product stability testing, ad-hoc investigational & development testing. There may be a requirement to execute/assist on new method transfers and validations. To support this volume of testing, ancillary laboratory duties including critical reagent screening/qualifications, laboratory housekeeping, review of paperwork and procedural updates are required.

Preferred candidates have work experience in multi-step synthesis of small molecules and should be able to design and develop practical synthetic routes to target compounds. A strong organic chemistry background with the ability to plan and execute complex syntheses is required. Successful candidates must have good verbal and written skills for communicating with management and clients. Excellent opportunity at all levels for growth and advancement.

The Engineer I - Validation / Engineer II – Validation / Validation Specialist I position supports Fractionation, Purification, Filling, Utilities and/or capital projects as required. This position is responsible for assigned qualification and validation related activities related to supporting the Clayton NC site.

The incumbent will work in a supporting function to provide scientific and technical assistance in the research and development of plasma derived or recombinant proteins. The position provides support to the Stability Group by overseeing all facets of the stability program that are related to oversight of the stability chamber areas, storage, delivery and documentation of the sample inventory in order to maintain a compliant stability program for licensed products and developmental projects, ensuring on-going safety and quality of our products.

This position is responsible for performing environmental monitoring of fill lines in SFF and PFF and also environmental monitoring of all classified production areas, including sampling of site utility systems. Environmental Assurance department must maintain adequate staffing to support all filling operations 24 hours per day, 7 days a week. In addition to routine environmental monitoring of the aseptic fill lines, this position is also responsible for executing the Quality Oversight program for the fill lines and also provides quality control approval of air flow visualizations conducted on site. This position is part of the budgeted staff necessary to complete this sampling and testing and to ensure that Clayton site environmental monitoring of the aseptic fill lines and other production areas and utility systems remain in a state of control. Must be able to perform tasks by following SOP’s and oral instructions. Must have precise, legible, and organized documentation skills. Candidates must also be willing to perform ones share of cleaning duties and housekeeping.

This position will play a key role in Alexion’s Viral Vector Product Development, Vector Production team, interacting with internal teams within the Genomic Medicine and Product Development Clinical Supply groups. The senior associate scientist will be responsible for supporting both upstream and downstream AAV manufacturing.

As a Scientist I (QC) in the Cambrex Analytical team, you will support a diverse range of client programs and be an integral team player within a highly cross-trained analytical core team. Execute analytical methods and provide general analytical support, such as release and stability testing of drug substances and drug products. Able to organize routine work independently and to evaluate, troubleshoot and interpret generated data. Demonstrated understanding of method development and qualification / validation principles. Routinely and effectively interacts with clients to discuss data and methods. Works on problems of moderate and sometimes advance scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.

We are seeking a Associate Scientistto join Q2 Solutions, IQVIA’s laboratory business at Durham, NC. The Associate Scientistwill perform routine analysis and laboratory testing procedures, ensuring compliance with SOPs and regulatory guidelines while supporting quality assurance and operational efficiency.

The Manufacturing Associate I/II (Manufacturing Associate) is responsible for performing upstream or downstream processing of bulk intermediates and/or bulk drug substances for biopharmaceutical products. The Manufacturing Associate must follow written, approved procedures and forms to ensure all work is conducted “Right First Time” (RFT) following Good Manufacturing Practice (GMP), including good documentation practices, and/or Good Laboratory Practice (GLP). As needed, the Manufacturing Associate will work individually or on teams to author standard operating procedures (SOPs) or Master Batch Records (MBRs); write corrective and preventive actions (CAPAs); and specify, commission, and qualify new equipment.

The Validation Engineer I/II will be responsible for facilitating the validation lifecycle process for the Validation Department to ensure all equipment and systems are in a qualified state suitable for the intended use. This may entail, assisting with the planning, development, project management, and execution of life cycle engineering and validation lifecycle documentation elements of engineering and validation lifecycle design, commissioning, maintenance, qualification, and the interfaces with quality system lifecycle compliance requirements.

Work with a cutting-edge genomics workflow to provide high-quality next-generation sequencing data with rapid turnaround times in a clinical laboratory. Perform routine testing, quality control, calibration, maintenance and proficiency testing in accordance with current laboratory procedures. Perform complex molecular-based procedures with a high degree of quality and in accordance with established protocols. Perform next-generation sequencing, including nucleic acid extraction, DNA/RNA quantification and qualification, NGS library preparation, probe hybridization, probe/library capture, library cleanup and quantification, loading sequencing libraries onto the Illumina Nextseq, HiSeq4000, and Novaseq. Sterilizing laboratory equipment and workspaces as assigned. Entering clinical patient data into the Laboratory Information Management system. Obtain 12 continuing education hours in the field of oncology or molecular biology. Maintain competency to perform all assigned molecular biology protocols in accordance with CAP, CLIA, NYSDOH regulations.

Perform physical counts of outsourced products received. Prioritize and perform attribute inspections of outsourced products. Process product requisitions. Process returned goods and assign disposition. Create and maintain product specifications for outsourced products. Accurately compare product specifications with product. Process Notice of Rejections and TrackWise records for damaged products and returned goods. Collect temperature data for temperature monitored shipments. Operate forklift or related warehouse equipment as needed to perform job. Maintain and report departmental metrics.

The Upstream Engineer/Scientist 2 will provide tech transfer support and technical oversight for a large-scale cell culture in monoclonal antibody manufacturing.

Conduct microbiological analysis on raw materials, solution, and water samples following approved Standard Operating Procedures in an accurate and timely manner.

We are looking for an individual to support a highly automated facility in North Cove, North Carolina. As a member of the Engineering department, the role will provide technical expertise to support plant manufacturing processes as well as other departments within the plant. In this role, you will focus on the implementation and adaptation of existing technologies of automation and associated processes in a manufacturing environment. The successful candidate must be a self-starter willing to assist the production and production service teams with hands-on troubleshooting.

The Environmental Monitoring Technician I is accountable for driving results in fast-paced environment by performing monitoring of the pharmaceutical manufacturing environment and utilities in compliance with cGMP and internal SOPs. The Environmental Monitoring Technician must be detail-oriented and possess organizational skills with a large quantity of data.

The Scientist II / III is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. The Scientist II / III may also be required to work on method development/method validation projects. For this position, HPLC, dissolution and/or GC based methodologies are commonly employed in the described testing. Other key methodologies applied include titrations UV, AA, IR. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company).

The Manufacturing Quality Assurance (MQA) Specialist is responsible for providing quality oversight to all manufacturing areas to ensure product quality and SOP/GMP compliance. The MQA Specialist will work closely with production personnel to complete in-process batch record review, resolve batch related issues, and ensure proper good documentation practices. In addition, the MQA Specialist will be responsible for performing routine environmental monitoring to assess the viable and nonviable particulate levels within classified manufacturing rooms and support rooms.

The role provides support for the various elements of the Quality System, including but not limited to the following: Deviations (Exceptions), Supplier Quality, Product complaints, Internal Audits, OOS, CAPA, Annual Product Review, Process control, Change Control, Validation, and identification/ recommendations for continuous improvement opportunities (internal/external). The Quality Engineer applies the appropriate statistical tools to analyze data, identify root cause and develop corrective actions for effective problem resolution of moderate to difficult scope and complexity.

The VPT Support Specialist is responsible for providing technical assistance and expertise to the CTI/Repligen sales force and customers related to the laboratory instrumentation its sells and supports. The laboratory technology developed and marketed by CTI/Repligen includes variable path length UV/Vis spectroscopy instrumentation. The systems are sold primarily into the pharmaceutical and biotech industry and are commonly used for quantifying concentrations of proteins and antibodies in drug discovery and development, manufacturing, and quality assurance. The VPT Support Specialist will provide support both at CTI/Repligen and on site at customer locations. The type of support will include system qualifications for Installation and Operation (IQOQ), product testing, system maintenance and customer training. Delivering training and support will involve travel to customer locations both domestic and international. Training will be provided by CTI/Repligen.

Manufacturing Associates perform processing steps and manufacturing support activities in our facilities in Research Triangle Park (RTP). These teams are the backbone of our operations – each person playing a critical role in delivering our therapies to the patients who need them.

Manufacturing Associates perform processing steps and manufacturing support activities in our facilities in Research Triangle Park (RTP). These teams are the backbone of our operations – each person playing a critical role in delivering our therapies to the patients who need them. This position will be in our Parenteral Filling operations, and our teams operate across the following units: Component Preparation, Compounding, Parenteral Filling/Lyophilization, Visual Inspection

This Senior Associate Research Scientist I position is in the CMC Development, Bioanalytics, Analytical Operations Group. The selected candidate will be responsible for conducting testing of process intermediates and final container in support of manufacturing, process development, developmental stability, validation and other R&D projects. Other responsibilities include cGXP documentation, sample login, data review, instrument maintenance and troubleshooting, data analysis, and other tasks assigned by management. The analyst may participate in development, execution, and qualification of new analytical test methods for characterization. The incumbent will be expected to work effectively under minimal supervision, and contribute to the team effort to support R&D projects.

As a key member of our R&D team, you will contribute to the preparation and assembly of medical and laboratory device components, playing a crucial role in the advancement of our projects. You’ll work hands-on in the lab to assemble tubing sets, prepare cell culture media, ensure sterilization, and maintain an organized and safe environment, all while following detailed instructions to support the development of next-generation medical devices and technologies.

The Manufacturing Quality Support Senior Associate provides Quality Assurance (QA) support to clinical, commercial, and contract manufacturing operations. The role ensures adherence to regulatory expectations, safety, and GxP (i.e., Current Good Manufacturing and Documentation Practices).The role is based at the Pfizer Sanford, NC Pfizer Global Supply (PGS) site.

The primary purpose of this position is to lead projects to design, test and technically document design and/or process changes required for the maintenance of released medical devices.

The Manufacturing Specialist, Cell Processing at ProKidney is responsible for supporting cell processing operations, ensuring compliance with cGMP guidelines in the development and production of regenerative medicine therapies. This role involves setting up and operating production equipment, including control rate freezers, orbital shakers, and other equipment, while contributing to efficient processing, freezing, and storage of cell therapy products.

This position is part of the Quality Control department located in Fargo, ND and will be an on-site position. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Quality Control Environmental Monitoring Team and report to the QC Environmental Monitoring Supervisor, and be responsible for sampling, detecting, quantifying, and identifying possible contaminants that may interfere with the quality of the product during the different stages of the manufacturing process.

We are seeking a Associate Scientist, Sample Preparation to join IQVIA Laboratories at Ithaca, NY. We hire passionate innovators who drive healthcare forward through thoughtful and inclusive collaboration. If you want to discover a career with greater purpose, join us as we transform and accelerate research and development. The Associate Scientist, Sample Preparation will be responsible for routine sample preparation duties, troubleshooting experiments, and preparing solutions and reagents to support laboratory operations.

We are seeking a highly motivated Research Associate to support discovery and development campaigns focused on next-generation biotherapies for serious and unmet medical needs. The candidate will work within the immunology team, conducting in vitro, ex vivo, and in vivo immunoassays on a diverse array of biological drug candidates.

Repligen is seeking an Associate Scientist to join our expanding Quality team.

The Chemist conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and BA Sciences. Standard Operating Procedures. Duties will include analysis of pharmaceutical products using HPLC, GC, Dissolution, AA, UV-Vis, Wet Chemical Analysis and Method Development.

The EM Microbiologist I conducts quantitative and qualitative analysis of pharmaceutical industries Environment according to FDA, ISO, cGMP and BA Sciences. Standard Operating Procedures. Duties will include Sampling of pharmaceutical industries through ISO standards and client specific test protocols.

This position is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch records, supporting test records and other ancillary support records. Will be a QA presence on the manufacturing floor.

The Quality Assurance Associate plays a pivotal role in ensuring that all quality assurance activities are conducted efficiently and accurately. Under direct supervision, the associate supports daily tasks that are essential for maintaining and improving quality systems and adhering to client-specific procedures. Key responsibilities include document management, review of manufacturing batch records, quality control (QC) data, facilitating material releases, overseeing final product releases, and providing essential assistance to the Quality Management as needed.

We are seeking an innovative and highly motivated Process Engineer on our MSAT team who will contribute significantly to establishing our IDMO Smart Factories. This position is focused on supporting the development and implementation of automated cell therapy manufacturing processes. You will work closely with the Process Engineering Lead and other cross-functional teams to execute, develop, design, optimize, and validate processes to ensure efficient, high-quality, scalable manufacturing solutions. This is a multidisciplinary role & this individual will interface across many parts of the company (with customers, scientists, researchers, and engineers) to develop the best solutions possible. Candidates should enjoy working in a fast-paced, mission-driven environment and be prepared to tackle a broad selection of challenges as the company grows.

Overview: Reporting to the Director, Product Quality Complaints, the Product Quality Complaint Associate, QA will play a key role in the complaint process. Specific areas of responsibility include ensuring accurate and thorough complaint intake information, assessing product replacement needs, troubleshooting issues with patients, including on phone support, conducting patient follow ups, supporting product complaint investigations, and tracking and trending complaint data. This position is based in our Bridgewater, NJ HQ (onsite 3 days a week).

The VPT Support Specialist is responsible for providing technical assistance and expertise to the CTI/Repligen sales force and customers related to the laboratory instrumentation its sells and supports. The laboratory technology developed and marketed by CTI/Repligen includes variable path length UV/Vis spectroscopy instrumentation. The systems are sold primarily into the pharmaceutical and biotech industry and are commonly used for quantifying concentrations of proteins and antibodies in drug discovery and development, manufacturing, and quality assurance. The VPT Support Specialist will provide support both at CTI/Repligen and on site at customer locations. The type of support will include system qualifications for Installation and Operation (IQOQ), product testing, system maintenance and customer training. Delivering training and support will involve travel to customer locations both domestic and international. Training will be provided by CTI/Repligen.

The Manufacturing Specialist will assist the shift lead in a hands-on approach to overseeing production activities including, filling, sterilization, component and equipment prep, and compounding. Completes quality systems activities including commitments, deviations, DCEs, and SOP revisions as necessary. Responsible for meeting budget, quality, and production goals, setting standards, and making employment and staffing recommendations. Interprets manufacturing policies, procedures, and programs

We are seeking a highly motivated and skilled Research Scientist to join our Crystallization R&D Department at Porton J-STAR. In this role, this position is responsible for leading group or contributing individually to conduct Solid Form Studies and pre-formulation will search for the right solid form and develop formulations to support preclinical and Phase I studies including PK, PD, efficacy, tox studies. This role is also responsible for Crystallization Process Development will develop crystallization processes to define and control final solid form of drug substances with desired solid-state attributes needed for optimum performance as well as drug intermediates for robust purification. The responsibilities of the position include, but are not necessarily limited to, the items listed below.

Pharmaceutical Ingredients (API), intermediates, impurities, starting material and excipients from drug substances and drug products. Analyze organic and inorganic compounds to determine chemical or physical properties, composition, structure, relationships, reactions, using chromatography, spectroscopy, spectrophotometry techniques including HPLC, UPLC, IC, GC, MS, UV,XRPD,DSC, TGA, NMR, and KF. Design and perform method verification and validation. Determine the specificity, linearity, accuracy, precision, forced degradation, robustness of the methods. Collect and analyze data, and maintain data integrity under GMP, GLP, and FDA regulations. Prepare documentation of test procedures and technical reports. Prepare, review, and/or approve methods, protocols, and development reports. Maintain laboratory instruments to ensure proper working order. Apply Scientific expertise to troubleshooting, laboratory investigation and problem resolution. Participate in maintaining high quality laboratory environment and comply with Health, Safety and Environmental responsibilities for the position.

J-STAR Research, Inc. operates as a contract research organization for pharmaceutical and biotechnology companies worldwide. It offers services in the areas of custom synthesis/contract research, process and analytical research, cGMP synthesis, crystallization process development, solid form screening and selection, pre/early formulation, and drug substance-drug product coprocessing.

Perform API crystallization process in compliance with cGMP and FDA regulations, utilizing analytical tools including chromatography, separation, and solvent selection; support crystallization process development by conducting studies involving compound properties and experimental conditions; participate in the scale-up development of enabling technology and experiments to facilitate the co-processing and development of API; conduct routine stability, performance, and evaluation studies for solid state characterization and pre-formulation support; support early drug crystallization process development for high potency compounds and controlled substance; purify pharmaceutical compounds using column chromatography, crystallization, trituration, extraction, and distillation; utilize experimental and simulation/modeling approaches to perform solvent selection and solve process challenges arisen from scale-up crystallization process; collect, analyze and maintain data integrity under Good Documentation Practice; write/review developmental chemistry, process optimization and process scale-up reports to support FDA requirements for CMC (Chemistry, Manufacturing and Control) sections of INDs/NDAs.

As a key member of the Analytical Development team, this individual will support developmental activities to aid in delivering gene therapy to patients. The successful candidate will support technical and development projects designed to characterize gene therapy products through an assortment of analytical methods. This role will also contribute to cross-functional activities including monitoring and characterizing of processes and products to identify opportunities for continuous improvement. Growth mentality and passion to serve patients, his/her technical team and development programs is a must.

Instrumentation Engineer (East Windsor, NJ) (Multiple Openings) Responsible for Instrument and Equipment’s of entire Plant; Installation, troubleshooting & calibration of instruments such as TOC Analyzer, HMI, PLC, Flow Meters, Temperature controller, transmitter, pressure transmitter, gas analyzer; Maintaining minimal instrument downtime through troubleshooting & maintenance activities; Maintaining data backup, instrument documentation, and Spares Inventory & Annual Maintenance contracts; Pro-active Support for Quality Control, Production & Compliance group’s activities; Follow-ups and closures of instrument Change controls, deviations instrument related incidents, & CAP A (corrective and preventive action); Procurement of qualified equipment’s as per GLP & Pharmacopeia requirements, and responsible for IQ, OQ, DQ and PQ for instruments and manage all paperwork.

Medical Diagnostic Laboratories (MDL), a member of Genesis Biotechnology Group, is a CLIA certified clinical laboratory with multiple state licensing, specializing in state of the art, automated DNA based molecular analysis of a variety of chronic and infectious illnesses. MDL specializes and performs Polymerase Chain Reaction (PCR) with a larger menu of testing available in the field of infectious disease. Our main theme of research is in the field of Gynecology, Infectious Diseases, Infectious Arthritis, Tick-borne Diseases, Mycology, and Chronic Fatigue Syndrome (CFS). MDL is looking for a Laboratory Technician. The Laboratory Technician is responsible for printing labels and attaching requisitions to the corresponding specimens.

Primary Responsibility for execution of bulk product batch processing, inclusive of all process related and administrative activities, as well as Equipment Preparation activities as declared in Compounder 1.

Performs complex molecular-based procedures on clinical samples with a high degree of quality and in accordance with standard operating procedures. Analyzes clinical results and provides diagnoses. Communicates and collaborates with other professionals within the company and clients, as needed • Properly uses and maintains laboratory equipment. Performs clerical tasks associated with clinical cases, including but not limited to: maintenance of specimen and case logs, preparation/documentation of assay worksheets, preparation of analysis sheets and clinical reports. Receives and verifies clinical samples. Witnesses hands-on clinical procedures. Participates in lab maintenance (i.e. cleaning, annual/bi-annual/monthly maintenance of equipment, unpack supplies, etc.). Complies with Safety Standards and Good Lab Practices. Performs additional duties or assignments as directed by management.

The Cell Processing Specialist is responsible for cell washing operations and verifying cell processing intermediate processing days of patient derived clinical and commercial cellular immunotherapy products. The CPS I will also be responsible for the formulation and verification of all media lots. Due to the nature of the starting material (patient cells) this role requires high level of proficiency and ownership of the process and media formulation.

The QC Microbiology Technician is responsible for assisting routine and batch-related Environmental Monitoring in controlled environments, following current Good Manufacturing Practices.

The position reports to the Director of QC, is ideally suited for a professional with extensive technical knowledge, and a proven track record of developing and carrying out processes, that are suitable for use in GMP manufacturing of a wide range of clinical trial materials, and participating in the technology transfer. There is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects that transform the lives of patients.

The Scientist II - QC is responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculating and reporting results on applicable specification documents, participating in method transfer activities within departments or between facilities or organizations. Provides feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture.

The Microbiologist I will provide support to the QC Microbiology Laboratory as pertaining to the respective responsibilities. Performs functions such as executing laboratory testing for in-process and finished good products, water, stability studies, and validation studies as well as performs environmental monitoring. This position is responsible for operating in compliance with all applicable procedures and policies.

Reporting to the Lab Operations Manager, Bldg. 104, this position is responsible for performing specialized duties required for the operations of the R&D lab, which includes supporting daily lab operations, assisting in driving lab compliance, supporting EHS compliance monitoring, document control and record management, inventory control, receiving, equipment maintenance, vendor management, technical project executions, and assisting in activities geared towards bio-/chemical safety and lab hygiene.

With supervision serve as study director/principal investigator to perform MD, MV/MQ and Sample analysis for Large Molecule (LM) Bioanalysis projects. Troubleshoots Wet Lab LM Bioanalysis assays issues and assist in training of LM analysts on wet lab LM systems. Can communicate; write responses to QC/QA findings. Communicate with Clients on specific projects that they are responsible. Accountable for accurate data submission and on time delivery of assigned projects.

At Theradex, you aren’t just a number. You are part of a highly engaged team of exceptional and supportive people who pride themselves on quality monitoring, continuous learning, challenge themselves and who reap the rewards of providing first in class monitoring to our sponsors.

This position is responsible for the timely sampling of incoming materials, supporting sample coordination activities and environmental monitoring of the facility and utilities at Ardena Somerset.

The Quality Assurance Specialist I will be responsible for the oversight of the Quality Assurance program and the Quality Management System at the site level.

Involve in the design, development, implementation, testing, documentation & support of cGxP systems as per 21 CFR Part 11 & US FDA. Responsible for qualification & validation (IQ/OQ/PQ), master plans, protocols, changes requests, gap & root cause analysis, risk management plans, traceability matrix, summary reports for facilities, equipment, systems & processes. Preparation, review, authorize & submission of documentation for quality compliance & regulatory authorities.

The primary responsibility for this Engineer I, Production Engineering position will be reviewing production documentation and addressing deficiencies found, performing equipment qualifications, and other improvements related to compliance issues. Lead and execute process validation requirements in parallel with identifying and implementing improvement and cost elimination projects for manufacturing. This position will report to the Supervisor, Manufacturing Engineering.

Indica Labs is looking for an experienced Integration Solutions Engineer. You will be responsible for configuring, optimizing, and maintaining integrations between various software systems and platforms, as well as managing integration projects and assisting with software installation and setup at client sites.

The primary purpose of this position is to perform work which involves general engineering methods and tools. As an entry level engineer, you will ensure that Integer’s internal and external customer expectations are met or exceeded with the direction, instruction and guidance from more experienced engineers and managers in your organization.

Perform analytical testing for Raw Materials, Finished and In-Process of Drug Substances and Products like Related Compounds, Assay, Content Uniformity, Dissolution, Blend Uniformity, Karl Fischer Titration, and other related Physical testing for the methods using instruments HPLC, UV/VIS, Dissolution (USP-I, II & III) and FTIR. Execute Method validations of Drug Substance and Drug Products including Related Compounds, Assay, Dissolution, Content Uniformity, Blend Uniformity as per ICH guidelines/USP /FDA requirements. Collaborative team player with excellent communication skills working in a highly dynamic, cross disciplinary environment. Develop efficient and selective analytical procedures and draft/review laboratory SOPâ_x0080__x0099_s. Identify discrepancies, initiate, and investigate OOS/OOT results. Perform timely and accurate peer review of analytical test results report/document in notebooks. Maintain QC lab related systems to ensure compliance with industry standards.

Provide daily repair and maintenance support for assigned products; Conduct in-house bench repairs as needed while primarily handling field service calls with limited supervision; Travel within the local region (including day and overnight trips) to support customer needs; Offer technical support via phone to customers and field personnel regarding repairs, maintenance and installations.

Design and conduct routine laboratory analysis using various analytical instruments and software such as HPLC, UPLC, ICP, and UV-Vis.

The Microbiologist is responsible for and has experience in performing microbial analysis for the QC Microbiology laboratory which is responsible for the analysis and disposition of commercial materials (raw materials, finished product release, stability, validation, investigation), and environmental samples, as assigned, and documenting results in accordance with SOPs.

This description outlines the employment prerequisites and job responsibilities for the position of Manufacturing Engineer within the Continuous Improvement Team. Provide support in the execution of the site’s operational optimization and quality improvement projects to achieve Medina Plant goals and objectives. Drive/support various quality improvement, business continuity/expansion, and cost reduction initiatives from identification through implementation while working with cross functional resources to ensure results are achieved in a timely manner.

This is a laboratory-based position within Pfizer’s Vaccine Research and Development (VRD) organization – Analytical Development group. The candidate assists with development of robust analytical assays in support of early vaccine development for a range of moieties such as mRNAs, proteins, and glycoconjugates. Representative assays include, but are not limited to, cell-based assays monitored by Flow Cytometry, Enzyme-Linked Immunosorbent Assays (ELISAs), and Bioplex/Luminex. The candidate also provides analytical support for bioprocess and formulation development by performing routine/non-routine sample testing. Your strong foundation in general scientific practice, principles, and concepts will help in meeting critical deadlines. You will be relied on as a technical contributor to assess the assigned tasks and make decisions that involve direct application of your knowledge. It is your focus and commitment that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

As QuidelOrtho continues to grow, we are seeking a Verification and Validation Engineer I to help with formal verification and validation of complex medical devices under the regulations of the FDA. The individual will be part of an engineering team that is responsible for requirements based test design and execution of test procedures both in a virtual and lab environment. The team is highly collaborative and will require regular interactions in formal reviews, test planning activities, and working with software development to reproduce and verify system defects.

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.

The Molding Engineer at LSI SOLUTIONS® plays a crucial role in creating and overseeing thermoplastic injection molding processes, utilizing scientific injection molding principles. The Molding Engineer will leverage their expertise to ensure consistent part quality and optimal cycle times. Additionally, they will provide oversight and foster collaboration with internal resources and external suppliers to ensure the implementation of best practices throughout the organization.

The Regulatory Associate applies her/his experience, knowledge, organization skills, and communication skills in a wide variety of tasks. Regulatory Associates provide regulatory feedback and guidance based on medical device regulations and standards to the company throughout the development cycle. Regulatory Associates monitor regulations, standards, policies, and guidance for new and current compliance requirements that may have impact to the company. They maintain technical documentation and help to implement change control at LSI. Regulatory Associates are assigned to work in one or more of the following areas: Domestic, European, Rest of World, Labeling, and/or Clinical & Post Market Surveillance. Regulatory Associates assigned to Clinical projects contribute to clinical evaluation, investigator brochures, post-market clinical follow-up, and post market surveillance. All Regulatory Associates will also maintain full Quality and Regulatory compliance with all standards that govern the design, development, manufacturing, and distribution of our medical devices.

The Cannabis Lab Associate Scientist plays a key role in laboratory operations, ensuring accurate and timely handling of cannabis samples for testing. This position is responsible for assisting with sample intake, weighing and preparing samples, and performing physical chemistry tests to support quality control and compliance. Ideal candidates are detail-oriented, possess a strong foundation in laboratory practices, and are committed to maintaining high standards of accuracy and precision.

Perform laboratory tasks by various basic methods. Generate and record data with minimal supervision in the performance of studies. Responsible for handling and processing samples and performing accurate data collection and reporting. We are seeking a Research Analyst 1- for our Immunology team at our Safety Assessment site located in Ashland, OH.

Provide technical leadership and utilize a background in materials for broad metallurgical support in a project team environment. Candidate will operate metallographic equipment for investigative purposes and communicate closely with others. Prepare, analyze and generate reports for the acceptance of metallographic specimens, primarily welded assemblies, but also includes determination of intergranular attack (IGA), plating thickness, EDM/laser recast layers, grain size, and general microstructural characterization to other specifications and in support of investigations. The candidate will be expected to have the ability to support or lead material-related investigations, develop laboratory best practices/standard procedures and manage metallurgical supply inventories. The ability to lead technical projects/investigations, manage documentation and time management skills are crucial. Familiarity with materials processing (i.e. melting, forging, heat treating, casting, welding, etc.), mechanical testing, metallography, EDM, plating, corrosion, and nuclear-grade materials is strongly desired.

Investigates and observes Operations and Quality Operations departments to assure that FDA current Good Manufacturing Practices, company SOPs and product registrations are followed and maintained. Conducts investigations of batches, preps, lots, equipment, and facilities in accordance with the Code of Federal Regulations. Assists the Operations and Quality Operations departments in satisfying all FDA and DEA requirements.

The Quality Control Analyst I performs routine laboratory activities in support of Good Manufacturing Practices (GMP) testing for Quality Control (QC). Performs in-process and release testing for drug substance and drug product. Interacts with employees internal and external to Quality Control.

The Specialist I, Quality Assurance performs routine activities associated with manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH. This position is responsible for document review which includes, but is not limited to: editing, formatting, and proofreading prior to SME approval in the Quality Management System. This position is also responsible for document archival and retention post product disposition. The Specialist I, Quality Assurance will report to the Supervisor, Quality Assurance or above and will support all document review and retention/archiving for the site.

The Specialist I, Quality Assurance performs routine activities associated with manufacturing of cell and gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH. This position supports the maintenance of the quality systems in support of a cGMP Operations, corrective and preventative actions, quality events management (e.g., nonconformances, deviations, etc.), training, document management and ensuring procedural and regulatory compliance throughout the manufacturing process. The Specialist I, Quality Assurance will report to the Supervisor, Quality Assurance or above.

We are seeking a highly motivated Associate Scientist with experience or interest in in vitro diagnostic (IVD) assay development to join our dynamic team. The successful candidate will perform laboratory work, data analysis, under the guidance of a supervisor. This role requires hands-on execution of experiments, routine lab maintenance, and meticulous documentation to support product development, validation, and verification initiatives. The position involves handling human biological specimens, including blood, plasma, urine, and other bodily fluids, in compliance with all safety regulations and company policies.

The GMP Operations Scientist I is responsible for supporting all aspects of Good Manufacturing Practices (GMP) production in the Clinical Manufacturing Facility (CMF). Working in collaboration with the manager of GMP operations and staff, the scientist, I will provide hands-on assistance for all day-to-day GMP production operations, including the execution of production processes, documentation, and facility and equipment maintenance. The Scientist I will support production efforts to deliver all products in a timely, compliant, and fiscally responsible fashion by following appropriate practices, production documentation, and Standard Operating Procedures (SOPs) for manufacturing biological products.

A Scientist II, in Process Devlopment, will support upstream and downstream process development activities including responsibilities in bioprocessing and analytics. Working in close collaboration with PD leadership and PD scientists, scientist II will support the execution and completion of projects involving platform development, optimization, in-process characterization, and tech transfer following appropriate regulatory practices, timelines, documentation, and standard operating procedures. Prior experience in the purification of biologics is preferred. He/She will keep abreast with state-of-the-art technologies and scientific advancements in the field and participate in discussions on scale-up of processes, process qualification, and strategies for process improvement.

The R&D/Product Development Engineering is responsible for the design, development of product line extensions of legacy product, with a focus on sustaining engineering of contactors/relays, power distribution panels and related products for applications in aerospace electrical power distribution and management systems. The ideal candidate should be able to work independently and within a team-based environment. Determine product requirements based on internal/external product design specifications and Voice of the Customer inputs. Plan and record results of design, development, and sustaining activities, including validation testing. Design to cost target while meeting financial and performance expectations. Manage Bill of Materials for products. Facilitate cost reduction activities on new and existing products. Perform calculations, analysis, and testing to ensure that a product meets specifications. Participate in and/or lead Design and Process failure mode and effects analysis. Provide support to both internal manufacturing, quality, Product/Project Managers, and external customers. Initiate and manage engineering change activities. Apply electrical, electronic, and mechanical principles to components, including assembly, analysis, and documentation of results. Supports, participates, and leads design, test, modification, fabrication, and assembly of prototype devices.

A Technician I is in training to perform and become proficient in on-boarding tasks, procedures, and cooperating in a team environment. The technician is learning basic tasks required to conduct a study, which may include collecting and recording data in the performance of studies. Responsible for handling and restraining animals, clinical observations, monitoring food consumption, animal husbandry, and performing accurate data collection and reporting. The technician is working under close supervision to gain proficiency

The Quality Analyst I performs quality control (QC) inspection and disposition of materials and products according to specifications. This role will perform QC inspection using measuring instruments (when applicable) and inspection methods. The role ensures any non-conforming materials or products that are identified are managed according to Axogen’s Quality System. The Quality Analyst is responsible for following all Axogen policies and procedures to ensure compliance with applicable FDA, state OSHA, and ISO regs and standards. Employees within this role will perform a variety of tasks under limited supervision.

In the assigned manufacturing area, directly supports the Aristada Manufacturing Process. Actively supports ongoing manufacturing efforts in terms of quality and efficiency, provides an interface with Development and Engineering in technology transfer of new processes and process upgrades to existing technologies, and supports Corrective and Preventive Action programs. Conducts real-time monitoring/trending of manufacturing processes and finished product analytical data.

This position assists in maintaining the cleanliness of the laboratory, the organization of supplies, reagents and standards. Additionally, this position provides a backup for the daily calibration and/or verification of the balances and pH meter when the Lab Technician is unavailable. The employee will have basic knowledge of commonly used laboratory concepts, practices, procedures and instrumentation and will perform tests commensurate with skill level with some supervision.

Sedia Biosciences is hiring a QC Assistant Scientist at our Beaverton, Oregon location. At Sedia, we create diagnostic and disease-monitoring products that provide cost effective solutions for rapid, near patient testing. We are currently seeking responsible individuals motivated to help research and develop our future diagnostic products. This position performs simple laboratory activities related to the inspection and testing or raw materials, components, and finished products in a medical diagnostic development and manufacturing environment following specific instructions from more senior Quality Control personnel or by following technical instructions

The Quality Specialist provides quality oversight, GMP guidance and support and makes quality related decisions for the designated functional areas within Sharp Commercial sites. They work closely with internal teams daily and occasionally represent Sharp Quality in customer interactions. The Quality Specialist is responsible to support, design and implement GMP initiatives and continuous improvement opportunities within the Quality Operations organization through data analysis, training, motivation and coaching in collaboration with internal and external stakeholders. Must possess a working knowledge of FDA regulations pertaining to Pharmaceutical /Pharmaceutical Packaging Operations.

Operate semi-automated and automated equipment in the production area at a sufficient rate and quality level. Perform on-line inspection of all components/parts produced. Take corrective action and/or make recommendations to the supervisor. Complete all paperwork and equipment logbooks and review other operator's paperwork for accuracy and completeness as required. Responsible for set-up and shutdown of equipment and work closely with the maintenance department in identifying maintenance and repair needs on the equipment. Provide cross training to operators on all pieces of equipment in the production area. Must follow all GMP and company safety regulations and guidelines. May assist in validation of equipment and be solicited for input into development and manufacturing process improvements.

Are you looking for a collaborative Associate Scientist role that allows you to contribute to designing innovative ways to use Engineering, Process Analytics Technologies, Automation and Modelling to develop medicines for patients? If so, this opportunity within the Sterile Process Engineering team would be the right fit for you. As an Associate Scientist you will join the Sterile Process Engineering and Analytics department of the Drug Product Development organization within the GSK R&D. You will primarily support drug product manufacturing process development using the small-scale capabilities, platform initiatives, combination product development, technology transfers, and new technology implementation for products in the pipeline.

In this role, you will be responsible for performing testing of products for internal and external customers using a variety of analytical techniques in a QC/cGMP environment. You may be assisting in updating procedures for instrumentation, test instructions, and test reports.

Conduct lab work as planned by the supervisor that involves development of pharmaceutical formulations such as tablets, capsules, and liquids. Conduct pharmaceutical manufacturing of oral dosage forms using small to large-scale equipment for development and process scale-up and for clinical supplies. Review and write master batch records with input from the supervisor. Prepare executed batch record folders. Comply with cGMPs, SOPs, and Company policies. Operate manufacturing equipment with the Operator for development clinical manufacturing. Maintain a planned training schedule and record. Completion of clinical batch manufacturing as per timeline. Ability to perform physical work while using a respirator. Read and interpret documents such as batch records, SOPs, policies, and safety rules; read and write business correspondence. Define problems, collect data, establish facts, and draw valid conclusions. Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Basic knowledge of physicochemical concepts and theories. Familiarity with the production process. Familiar with a variety of in-process equipment, such as disintegration, friability, particle size, etc.

Generate and record data with minimal supervision in the performance of studies. Responsible for handling and processing samples and performing accurate data collection and reporting. Perform laboratory tasks by various basic methods. ESSENTIAL DUTIES AND RESPONSIBILITIES: • Perform basic laboratory procedures and collect and record/document research data in compliance with Good Laboratory Practices (GLPs), Standard Operating Procedures (SOPs), study protocols and company policies/practices. • Input, print and edit computer entries (e.g., laboratory data). • Prepare materials and data for shipment and archiving. • Receive samples and complete tracking documentation. • Review documentation of functions performed as part of quality control requirements. • Perform study preparation activities. • Maintain clean work areas. • Perform all other related duties as assigned.

Pacific Edge Diagnostics USA, an innovative cancer detection testing company is seeking a talented Clinical Laboratory Technician to join its team. The Clinical Laboratory Technician's primary responsibility will be to perform molecular clinical testing (from specimen receipt through reporting patient results), as well as general lab maintenance.

Responsible for performing daily laboratory tasks as they relate to Microbiology Testing Services.

LifeSensors, Inc. is a global leader in research involving the Ubiquitin Proteasome System (UPS) a cellular pathway that degrades damaged proteins. UPS provides a challenge as a new wave of drugs are emerging, such as PROtein TArgeting Chimeras (PROTACs) and Molecular Glues that target undruggable space. Our technologies are used worldwide by academic, pharma and biotech companies. As the company grows, it is critical that we continue to innovate. The scientist will be a part of research programs to develop innovative technologies, execute drug discovery projects for our clients, as well as drive the development of new products and product applications. They will write scientific articles, patents, and present data at national and international meetings. Please consult our website www.lifesensors.com for more details.

TE Connectivity’s R&D/Product Development Engineering Teams conceive original ideas for new products, introduce them into practice. They are responsible for product development, and qualification from market definition through production and release; assist in the qualification of suppliers for new products to ensure suppliers deliver quality parts, materials, and services for new or improved manufacturing processes; conduct feasibility studies, testing on new and modified designs; direct and support detailed design, testing, prototype fabrication and manufacturing ramp. The R&D/Product Development Engineering Teams provide all required product documentation including, but not limited to, Solid Model, 2D/3D production drawings, product specifications, and testing requirements. They create and modify detailed drawings and drafting or conceptual models from layouts, rough sketches or notes and contribute to design modifications to facilitate manufacturing operation or quality of product. Typical fields of expertise include: materials, mechanics and systems, electrical, optics, chemistry, software, automation systems, packaging, testing and measurement, and manufacturing of electrical, mechanical and electronic components, products, and their integration into systems.

The QA Technical Reviewer will be responsible for GMP review and comment on laboratory raw data, procedures and reports to ensure methods, protocols and other procedures were properly followed, results are analytically accurate and correct, and that all documentation meets GMP standards.

The PCR Specialist 1 is responsible for the formulation of highly complex PCR products and sub-solutions within the required timeframes and production schedules, in compliance with established Safety and Quality standards. They will be responsible for the proper handling and accurate pipetting of numerous different raw materials, combining 5-15 components into a final chemical formulation. Additionally, they will be responsible for the proper dispensing and labeling into final, customer facing formats.

Our close-knit, medium-sized company is composed of smart, curious, diverse scientists who take an active interest in the scientific and technical development of our team members. We are seeking a skilled and organized Laboratory Manager to oversee our cell and molecular biology research and production facility. This role focuses on operational oversight and team management to ensure efficient laboratory operations and support of scientific teams.

Our company is in an exciting growth phase where we are launching new products and reaching new markets. To support our growth, we seek a Research Technician to join our Membrane Proteome Array research team.

The Quality Control Analyst I- Microbiology will support quality control testing operations at Iovance’s Cell Therapy Center (iCTC) and/or iPBMC manufacturing site (IOVA-A). The quality control testing programs include in-process and final drug product microbial testing such as bioburden, endotoxins, mycoplasma, gram stain, environmental monitoring, and sterility techniques. This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to complete assigned work.

The MSAT Specialist I is a Manufacturing Operations cell therapy subject matter expert. The MSAT Specialist I reports to the Senior Manager, MSAT and EM and is responsible for manufacturing data analysis, contributing to deviation root cause analysis, and owning steps of the manufacturing process tech transfer. The MSAT Specialist is also responsible for protocol and report authoring, oversight of manufacturing operations, and execution of MSAT laboratory activities.

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking a Quality Control (QC) Compliance Investigator who will in advance and close QC related investigations. Strong technical writing skills are required. Experience in a CAR-T or TIL environment is a plus. The ideal candidate will have experience working in a GMP-regulated laboratory with experience in writing investigations.

The Quality Control Analyst will support quality control testing operations at Iovance’s Cell Therapy Center (iCTC). The quality control testing programs include in-process and final drug product microbial testing such as bioburden, endotoxin, gram stain, environmental monitoring, and sterility techniques.

lovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. lovance is seeking an Investigator I, for the Quality Control Compliance team who will in advance and close QC related investigations. Strong technical writing skills are required. Experience in a CAR-T or TIL environment is a plus. The ideal candidate will have experience working in a GMP-regulated laboratory with experience in writing investigations.

Ecolab is looking for a R&D Technical Analyst who will perform a variety of routine tasks to maintain product specifications including mechanical or chemical characteristics of an item or product, who will work under minimal supervision and receive instruction only as necessary. The successful candidate will work on assignments and performs tasks that are moderately complex, where discretion is required in resolving problems and making routine recommendations regarding creation or maintenance of product specifications.

Responsible for manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).

The successful candidate will have an interest in developing construction work packages for the electric distribution system using various software systems and construction standards. Distribution systems may be in an OH, UG, or URD environment. Project work may include joint use make ready, and street light projects. Work packages will be developed using Geographic Information Systems (GIS), Computer Aided Design (CAD) tools, Work Management Systems (WMS), and other client systems. Project work will require performing engineering calculations that may include: structural analysis of poles, guying, cable pulling, electric demand, transformer sizing, voltage drop and flicker, and coordination of protective devices. Assignments may also include: preparing forestry trimming requests, facilitating permit and Right-of-Way acquisition, development of a BOM, estimating costs, and customer advocacy such as acquiring easements. Work assignments will include travelling by motor vehicle to various project locations located throughout the area to conduct field investigations. The associate level candidate need not be proficient in applicate customer engineering, construction standards, and software systems. Training will be provided by Leidos.

Revvity is seeking a Customer Support Engineer to join a customer focused field service team in our High Content Imaging Business Unit for the Mid-Atlantic territory (PA, NY & NJ regions). The High Content Imaging Business Unit focuses on the sales of Opera Phenix Plus and the Operetta CLS and related products. The successful individual will provide field service support for the continuously growing High Content Imaging install base in the United States including installations, training, customer training, preventative maintenance, and repair. The individual will also assist with technical support to end-users and field service engineers.

The Quality Engineer is responsible for maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable standards. This role supports complaint/CAPA investigations, supplier quality improvement, operations production and process controls, and product and service quality improvement with the use of statistical techniques and other accepted quality principles. This role executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems. This position is located in the greater Philadelphia area.

We are looking for an energetic, highly motivated and collaborative Associate Scientist candidate with demonstrated expertise in cell therapy process development and process innovation. In this role, the successful candidate will be involved in process design, unit operation development, and parameter optimization studies resulting in the development of new production processes. The successful candidate will work as part of a cross-functional teams supporting pre-clinical and clinical programs, focused on autologous processes.

Sanofi is seeking a motivated professional candidate to operate within Biologics production and perform manufacturing activities. This is an exciting opportunity for a candidate to develop technical skills and learn about the biopharmaceutical industry. The production technician will operate in a cGMP manufacturing area performing equipment set up and operations tasks to meet all standards for safety, quality, and efficiency. The candidate will perform production in accordance with volume fluctuation, business need, and effective procedures.

Performs routine checks on equipment to verify parts are in good condition, ensures equipment is functioning properly, and documentation and recordkeeping is maintained, Arranges equipment replacement and repairs as needed, Coordinates with laboratory staff, and safety to properly maintain and remain compliant in common/shared equipment including preventive maintenance (PMs), service, repair, calibration, and certification, Ordering new equipment, Prepares purchase requests, obtains quotes and interacts with purchasing personnel, Schedules and coordinates instrument installation, Facilitates instrument/equipment training with lab staff, Supporting Lab staff with lab maintenance, Freezer/ fridge maintenance, Benchling Inventory compliance, Shared reagent/ biologics inventory, Maintain/ order supplies in compliance with ‘hazardous materials’ (COSMIC), Submitting shipment requests- within and outside of the facility

Our company a global healthcare leader, is currently seeking an Entry-Level Laboratory Animal Resources Associate to join our collaborative, dynamic, and inclusive Laboratory Animal Science Team at the West Point location. The successful candidate will be integral in planning, designing, and executing in vivo ophthalmology research, as well as some routine veterinary and animal colony management tasks. On-site and hands-on study-related lab work will be a crucial part of the role. The role also requires rotation weekend work and the ability to apply sound technical skills to assigned tasks, often with minimal supervision.

We are hiring an entry to junior level Metrology Technician responsible for conducting routine calibration tasks in alignment with established protocols and regulatory mandates. The position adeptly handles troubleshooting and equipment repair as needed, while ensuring the steadfast adherence to quality system compliance standards.

This position supports the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. This individual will work with supervisors, engineers, technicians, and operators to address problems and opportunities identified on manufacturing lines. He or she will be accountable for quality, safety, product output and yield initiatives, as well as providing line support on a daily basis.

Performs on-the-job, group, and one-on-one trainings with Environmental Monitoring (EM) program personnel. Coordinates and utilizes different departments and resources for task specific trainings. The EM Trainer is an expert on monitoring performed as an EM Technician I, II, and III. Assists with additional work duties or responsibilities as evident or required.

Evaluates situations, selects and applies standard engineering techniques, procedures and criteria, using judgment in making minor modifications. Assignments have a clear objective and require planning and investigation of limited number of possibilities. Work is reviewed for application of sound judgement and compliance with contract technical requirements and meeting of Division policies and procedures. Receives instructions on specific assignment objectives, complex features and possible solutions. Assistance is furnished on unusual problems and work is reviewed for application of sound professional judgment.

Provide engineering support for introduction of new products and alternate repair activities. Function as Project Coordinator on more complicated projects as defined by the Manager by providing technical information to other project participants recommending cost effective procedures tracking and maintaining implementation dates and documenting completed projects. Provide support to Associate Engineer on their assigned projects.

As a Shift Manager, you will be responsible for managing a shift of approximately 15-20 individuals. As the leader of this team, you will be responsible for setting high standards for your shift while ensuring all performance metrics are met on time and within cost. In this role you’ll act as a key business partner to operations leadership and cross-functional partners, assisting with driving efficiency and implementing scalable processes. This position requires a results-oriented, high-energy individual with the stamina and mental agility to thrive in a fast-paced startup environment.

This position assists in analyzing specimens and maintaining equipment in good operating condition to ensure accurate and timely testing of patient samples. This role involves adhering to Good Laboratory Practices (GLP), troubleshooting equipment malfunctions, providing guidance to new team members, and maintaining compliance with regulatory standards. The technician plays a crucial role in supporting laboratory operations, ensuring a clean and organized workspace, and contributing to continuous improvement initiatives.

The Instrument Support Engineer is responsible for the service and support of laboratory equipment and instrumentation utilized in the Operations laboratory. The scope of support includes installation, calibration, maintenance, and repair of both simple (e.g., plate sealers) and complex (e.g., liquid handling robotics) instrumentation in the laboratory. The Instrument Service Engineer will be the primary point of contact for production lab personnel when equipment and instruments are not operating or not meeting operational specifications.

As a Quality Systems Specialist, you will work with teams across the Neuralink organization to resolve isolated and systemic problems through NCRs and CAPAs. You’ll identify ways to trend defects and issues for broader audiences and leadership. This role involves communicating and collaborating with different teams, such as R&D, manufacturing, product, etc., to maintain document/change management and data systems and ensure regulatory compliance with applicable standards.

The Specimen Processor in this CLIA Laboratory is a critical member of the laboratory team, responsible for receiving, accessioning, and documenting specimens with precision. This role requires accurate data entry, proactive identification, and resolution of sample integrity issues. Flexibility in scheduling, including holidays and variable shifts, is essential to meet operational demands.

Join our innovative team at Agilent Technologies as a Manufacturing Scientist specializing in genomic reagents. You'll contribute to ground breaking products that advance Next Generation Sequencing (NGS), Microarray testing, and PCR-based technologies. If you're passionate about driving scientific advancements and thrive in a dynamic, collaborative environment, this role offers an exciting opportunity to grow and make a tangible impact.

The Quality Assurance - Compliance Specialist II - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.

The Manufacturing Process Engineer I is an integral part of the Manufacturing Technical Operations department located in College Station, Texas. This position will report directly to the Manager of Technical Operations, Manufacturing.

The QC Stability Coordinator I, will construct, maintain, and oversee the Quality Control Testing of Stability programs to include developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data. The Quality Control Coordinator I, under general direction, will be responsible for implementing a Quality Control Stability Program that will encompass the needs of the client for each program. The position will require frequent communication with the Chemistry, Cell Biology, Microbiology, and Quality Assurance groups to coordinate execution of testing, deviation management, and issuance of deliverables. The Coordinator will have visibility to method qualification to ensure timing of stability laydowns. Close attention to detail is required to oversee scheduling the stability testing and compiling data, to facilitate meeting deadlines and milestones. Other responsibilities may include but are not limited to: ownership of CAPA’s and deviations, client meetings, attending planning meetings, communication of changes, and utilizing new software.

Responsible for analysis and reporting of various products such as crude oil, fuel oils, middle distillates, petroleum and petrochemicals, LPG & LNG gases, etc.

The primary function of a QC Chemist is to perform qualitative and quantitative chemical and physical analysis in support of raw materials, in-process samples, components, and finished drug products testing.

As a Control Systems Engineer supporting our manufacturing site, you will be trusted with providing engineering skills and support to help develop software and hardware control solutions and for the design, programming, installation, modification, troubleshooting, and improvement of major systems at Houston, TX.

A PBMC Laboratory Technician will be responsible for conducting special laboratory procedures for clinical trials performing high complexity laboratory techniques including, but not limited to routine isolation of peripheral blood mononuclear cells (PBMC), or other laboratory procedures, etc., ensuring safety measures are followed by facilitating laboratory operations.

Reporting into the Senior Scientist, Analytical Development, the Associate Scientist, Analytical Development plays a critical role in ensuring analytical work is executed consistent with product development timelines for Neurogene’s product pipeline. The candidate will perform routine sample testing according to standard operating procedures to support Process Development activities and process transfer to manufacturing. The selected candidate will have the ability to perform different laboratory techniques as well as superior written/oral communication skills, which are essential for success in this key role in a rapidly growing start-up. Furthermore, the candidate will be self-motivated and able to work both independently and within a collaborative team environment.

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Data Coordinator to join our Data Management team. This position involves working on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your knowledge and experience to further develop and grow your career even further, then this is the opportunity for you!

Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Data Coordinator to join our Data Management team. This position involves working on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your knowledge and experience to further develop and grow your career even further, then this is the opportunity for you!

The Associate Quality Engineer engages with cross-functional team members and suppliers to drive Quality performance and to ensure that product quality meets all internal and external requirements. They will support initiatives to improve quality and customer satisfaction. The Associate Quality Engineer position also ensures compliance with Quality system and other standards and regulations, company quality requirements and corporate objectives.

Testing of chemical components or products. Will involve the use of major laboratory instruments and equipment: HPLC, GC, FTIR, UV/VIS, as well as utilizing wet chemicals skills. Analytical review of data to ensure calculations is complete and accurate. Performs quantitative chemical analyses of APIs and related materials under direct supervision following established procedures and guidelines using laboratory instrumentation such as gas chromatographs, liquid chromatographs, ultraviolet-visible spectrophotometers, etc. Performs microbiological analysis as required. Treats numerical data throughout chemical analysis by performing mathematical calculations such as determining concentrations (molarity, parts per million, normality, etc.) and statistical information (standard deviation, mean, etc.). Prepares necessary reagents and equipment to expedite the performance of analysis by measuring and/or weighing chemicals, missing, and standardizing solutions, and assembling equipment. Maintains accurate records by logging samples received, recording samples analyzed, procedures used, and results obtained on datasheets and/or laboratory notebook. Weights and calculates samples in the physical and chemical analysis of products using balances and measured volumetric containers. Recognizes and informs Group Leader about daily lab activity and analytical problems. Organizes and properly labels samples, sample preparations, volumetric solutions etc. Perform other duties as assigned.

Are you an experienced Clinical Lab Professional? If so, LabCorp wants to speak with you about exciting opportunities to join our team as a Technologist at in San Antonio, TX. In this position you will work in a fast paced, customer focused, and challenging environment, and will be a part of our overall mission at LabCorp: “Improving Health, Improving Lives”.

As a Senior Scientific Associate in Biomarker Analysis, you will be a key contributor to our bioanalytical team. Your role involves method development, validation, and sample analysis for ligand binding assays. You’ll work closely with the supervisor to ensure accurate and efficient execution of bioanalytical processes. If you’re passionate about advancing bioanalysis research and have a strong foundation in bioanalysis, this role is for you.

We are looking for someone with expertise in classifying diseases/conditions by medical specialty. Contract work on a task basis. Must be able to accept payment by PayPal or Venmo. Send us a message through the contact form if interested.

As a R&D Engineer you will perform engineering verification and validation testing activities within FDA QSR standards with guidance of senior engineering. Reporting to the Manager Senior, Engineering you will be located in Salt Lake City, Utah.

The position will be responsible for customer relationship management and collaborating with interdepartmental teams to ensure proper resolution and close out of regulated documentation in the CRM system. The FSE will manage all preventative maintenance and system upgrades of instrumentation and its interface at the customer site and provide troubleshooting to diagnose and resolve technical issues on a variety of electromechanical, fluidic and medical devices . Deals with diverse and oftentimes complex issues where analysis may require in-depth evaluation of many factors, and functions as the reference for troubleshooting, investigations and log analysis for FSE team members within and outside the assigned region. The team is looking for an individual with first electrical / mechanical work experience. Independently exercises judgement in evaluating methods and determine criteria for obtaining solutions is a must. The FSE is required to live within 50mi of the Metro Atlanta area.

Performs basic QC analysis and documents activities according to SOPs following good manufacturing processes (GMP) and demonstrates ability to learn QC methods, procedures and systems.

The role of the Manufacturing Associate is to act as a controller, providing essential duties to support the respective production suite, Supervisor, and Manager. On a daily basis, the Manufacturing Associate is expected to have a full understanding of the schedule and required tasks; promoting adequate assessment and response of any production demands.

The Regulatory Affairs Associate requires application of regulatory knowledge and project management skills to oversee international registration of new products. As the Regulatory Affairs Associate, you will also work with Regulatory team members & international teams to drive systems & process improvement activities for integrated regulatory compliance and global submission processes, including labelling, clinical affairs, new product development, international regulatory requirements and other areas as assigned.

Assist in daily activities and operation of the Laboratory Sciences department including equipment maintenance, stocking supplies and general cleaning. Support and perform data collection activities including LC-MS/MS, qPCR, DNA isolation, ligand binding assays, and flow cytometry, as assigned.

We are seeking a skilled Research Associate/Senior Research Associate with experience in utilizing display technologies (yeast/phage) in protein engineering, directed evolution, or binder discovery. This is a laboratory-based role that will be supporting protein engineering efforts in discovering novel binders and novel protein leads/scaffolds. The position will join a growing protein engineering team in an innovative organization and reports to the Director of Protein Engineering. The ideal candidate will be a quick learner with a broad experience set with direct expertise in a display technology and/or an adjacent field including but not limited to high throughput molecular biology, antibody/binder discovery, and protein engineering. Industry experience in biologics drug development is required.

We are seeking a meticulous and dynamic Senior Research Associate to join our translational chemistry team. As part of this role, you will be responsible for conducting and supporting laboratory research, ensuring the highest standards of quality and precision. Your contributions will be critical to the success of our research and development efforts, and you will have opportunities to work both independently and collaboratively within our innovative team.

Lumen is seeking a highly motivated, innovative Associate Scientist to join our team. The Associate Scientist will work with and support scientists in the Biologics research and development team. The work will involve various projects at different stages of the pipeline. The individual is expected to develop, optimize, design and execute a broad range of cell culture-based experiments and assays, as well as prepare and maintain cell line stocks. The individual is also expected to follow established protocols to perform assays, record, analyze, and report results. The position requires the ability to work as a team member in a fast-paced environment, have strong organizational skills, and take meticulous records. Effective communication skills are crucial in coordinating with the relevant teams to meet milestones and deadlines and in raising quality or troubleshooting issues as they may arise. The position will need to provide status updates and present in group meetings and company-wide meetings.

The Environmental Monitoring department performs the functions associated with sampling, initiating tests, collecting and evaluating test results related to defined quality parameters for surface, air, personnel, product and utility systems such as compressed gases and WFI. The Specialist oversees EM functions and personnel, schedules tasks and personnel, assists in training EM Technicians and gown training of all aseptic personnel.

The Validation Associate works closely with the Validation Specialist in support of capital, contract, and compliance projects. This position is responsible for executing a variety of validation studies, including performance qualifications and/or requalifications for terminal and component sterilization work.

The QC Microbiologist I-II performs the microbial analysis on allergenic and client components, raw materials, intermediates, and finished products following written procedures, providing the data required to determine raw materials/product disposition.

The QC Scientist II performs the analysis on allergenic and client components, raw materials, intermediates, and finished products following written procedures, providing the data required to determine raw material/product disposition.

The QC Scientist I/II/III/IV performs the analysis on allergenic and client components, raw materials, intermediates, and finished products following written procedures, providing the data required to determine raw material, product disposition. In addition, this position demonstrates leadership, teamwork and technical expertise.

Join Bio-Rad as our Quality Engineer and work in our Woodinville, WA site! Working in this Quality Assurance role, you will attend cross functional Daily Management meetings and represent Quality Assurance to address blocking issues and implement counter measures. You will manage the Material Review Board and ensure thorough data-driven documentation of non-conformities and risk based determination of CAPA. You will review data for trends, manage corrections and corrective action and support Global Supply Chain and business partners as requested.

The Radiopharmaceutical Manufacturing Associate performs duties to support the development and manufacturing of radiopharmaceuticals for NorthStar operations. This includes equipment preparation, product dissolution, and dispensing of medical radioisotopes while complying with procedures, instructions, and prescribed routines. All duties and responsibilities will be completed in compliance with applicable regulatory agency standards.

Arrowhead Pharmaceuticals is seeking an Associate Scientist to join the Discovery Chemistry Department. The successful candidate will primarily focus on oligonucleotide synthesis, purification, analytical chemistry, and contributing to specific program goals. The Associate Scientist will be joining a team of highly motivated and experienced scientists and will contribute to the success of Arrowhead programs.

eGenesis is seeking a Research Associate II/Senior Research Associate to join the Process Development team and contribute to projects in andrology, embryology and cell culture. In this role, you will have the opportunity to get hands-on training from experts in these areas. Daily activities include execution of experiments, recording of data into electronic notebooks, and collaborating with other members of the Process Development team. By improving the pig production process, we contribute to the xenotransplantation program of eGenesis.

Empirico, a clinical-stage biotechnology company that combines unmatched expertise in human genetics-driven target discovery with world-class capabilities in siRNA medicines, is looking for a talented scientist to help advance our growing pipeline. This position offers a unique opportunity to participate in and support multiple projects in diverse therapeutic areas, across different stages of preclinical development. You will work closely with other scientists that have a passion for finding novel approaches toward the treatment and prevention of disease.

Empirico, a clinical-stage biotechnology company that combines unmatched expertise in human genetics-driven target discovery with world-class capabilities in siRNA medicines, is looking for a talented chemist with experience in solid-phase oligonucleotide synthesis and analytics. This is an excellent opportunity for a highly motivated, creative scientist to be a vital member of our team.

The Calibration Lab Technician I is responsible for performing calibration, maintenance, and repair on a variety of equipment sent into the calibration lab (e.g., pipettes (single & multi-channel), bottle top dispensers, load cells, masses, timers, temperature measuring equipment, etc.). This role will demonstrate a high level of organization, the ability to multitask and build trust with internal and external customers.