Links to 531 Entry-Level Biotechnology & Life Science Jobs

As a Senior Associate Scientist in the Early Bioprocess Development within Pfizer Vaccine Research and Development, you will be at the center of our operations and you’ll find that everything we do, every day, is in line with an unwavering commitment to quality. You will join a large team of Scientists focused on conjugation process development for manufacturing carbohydrate-based conjugate vaccines. Primary duties include supporting the development and optimization of conjugation methods, purification, and analysis of intermediates and glycoconjugates using chemical and chromatographic methods. The individual will become a key contributor towards supporting the early development and scale up of glycoconjugate vaccines. Careful documentation of work and presentation of data is required. All work is to be done in a compliant manner according to SOP guidelines and cGMP/GLP regulations, where applicable.

We are seeking a Systems Scientist II, Product Development to join our Research & Development team. In this role, you will contribute to the development, integration, and optimization of products and technologies by applying a systems-level approach to scientific and technical challenges. The successful candidate will be a collaborative, results-oriented scientist with strong scientific and technical acumen and a demonstrated ability to contribute to product development from a systems perspective. This role requires hands-on laboratory experience as well as the ability to investigate and troubleshoot issues across assays, reagents, instrumentation, hardware, software, and workflows. You will design and execute experiments, analyze and interpret data, identify root causes of technical issues, and develop and demonstrate solutions that improve system performance and product robustness. You will work closely with cross-functional partners to translate experimental findings into actionable recommendations and support product development milestones.

As a Lab Supervisor you will coordinate staffing and resources, support day-to-day workflows, and assist in preparation and implementation of company policies, quality systems and training programs. This role ensures that projects are completed in a timely manner so that company revenues are met, and clients are satisfied with the quality and turnaround of work being performed. The Lab Supervisor also ensures that staff continue to be developed to keep pace with department goals and growth.

Join our growing validation team supporting Automatic Visual Inspection (AVI) operations, a critical and expanding function within sterile pharmaceutical manufacturing. With new lines being added—including auto-injector technology—this role offers hands-on experience in one of the most in-demand areas of the industry. This is an entry-level opportunity designed for growth, where you’ll gain valuable, highly marketable experience in sterile manufacturing validation.

Provides line-level management coordination of resources and work schedules. Oversees daily operations and assists in preparation and implementation of company policies, quality systems and training programs. Ensures that projects are completed in a timely manner so that company revenues are met, and clients are satisfied with the quality and turnaround time of work being performed. Ensures that staff continue to be developed to keep pace with department goals and growth.

Assists the Quality Assurance team in maintaining compliance with key quality system processes and contributing to continuous improvement efforts.

Our Lead Production Technician – ILP plays a vital role within our organization. Once you complete our training, your responsibilities will include s for overseeing planning, scheduling, staffing and daily execution for the inspection, labeling and packaging of compounded sterile products (CSPs), and non-sterile solutions. The incumbent in this position is responsible for daily coordination and working schedules of people and equipment who will be performing in production operations. As part of this role, the Lead will need to ensure proper line controls are maintained, that appropriate documentation is available, and that batch records and corresponding documentation is completed in a timely manner. The Lead will need to coordinate activities to ensure line support and staffing is available and that people operate within safety requirements, current Good Manufacturing Practices (21CFR210 and 211), company policies and procedures. At Quva, you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

Our Production Technician I – Formulation plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical product. Once you complete our training, your responsibilities will include supporting daily manufacturing activities for non-sterile and sterile bulk/CSP operations. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

We are seeking a detail-oriented individual to join our team as an R&D PDM Assistant with a minimum of 1-2 years’ experience in an analytical testing laboratory or a manufacturing facility. This individual will be integral in the start-up and technology transfer for our R&D laboratory, supporting the launch of a new GMP manufacturing production site for Over-the-Counter (OTC) products and Vitamins, Minerals, and Supplements (VMS), based in Wilson, North Carolina.

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Process Development Associate to join our Cell Culture Development Group within Preclinical Manufacturing and Process Development (PMPD), supporting early-stage development in a non-GMP process development laboratory. In this role, you will develop production processes for monoclonal antibodies by screening top candidates, selecting cell lines, and developing media and feeds while collaborating with cell line development, purification, analytics, and manufacturing teams.

The Obesity, Muscle and Metabolism group is seeking a highly motivated Associate Scientist to support the development of therapeutics for muscle diseases. This role involves joining a productive and collaborative team working on treatments for muscular dystrophies, myopathies, and myositis, with the opportunity to engage in cutting edge tissue engineering, disease modeling research as a part of our discovery efforts. This is a lab-focused role suited for a bench scientist with a strong foundation in cell biology and physiology, as well as experience in cell culture and tissue engineering. You will be developing assays for validating molecular and functional readouts for our therapeutic programs.

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking to fill a Quality Compliance Specialist (Quality Risk Management) position. This position is responsible for supporting Regeneron’s Internal Drug Product Manufacturing operations through the use of quality risk management (QRM). Job functions will primarily consist of the broad application of patient centered QRM across a full spectrum of processes vital to the operations. Specifically, the active facilitation of quality risk assessments, risk reviews and other quality risk-based programs supporting the Quality System (e.g., change control, deviation management, etc.). The person in this role will be consistently challenged with assignments, touching almost every phase of our process.

The Associate I, PDT is responsible for supporting the day-to-day operation of the PDT laboratories and process activities. The Associate I will perform routine upstream, downstream and drug product formulation process steps to support projects and will provide support for process characterization and formulation development activities.

The Quality Assurance Associate supports the effective operation of the Quality Management System through accurate and timely administration of document control, training, equipment calibration/preventive maintenance, and related quality records. The position is responsible for executing established quality system processes, maintaining required logs and records, monitoring routine due dates, and escalating issues in accordance with approved procedures. The QA Associate works collaboratively with the QA Specialist and Sr. Quality Systems Engineer. The roles are expected to coordinate closely and provide cross-training and backup support for assigned processes; however, the QA Associate does not report to the QA Specialist. The position operates under departmental management and escalates quality decisions requiring independent technical or compliance judgment.

BioLegend’s Research Associate position conducts antibody characterizations and supports product development in Immunology, Oncology, Stem Cells and Neuroscience and entails various antibody applications including SDS-Page and Western blot, Immunoprecipitation, ELISA, flow cytometry, immunocytochemistry, immunohistochemistry, etc. This position will be responsible for troubleshooting and effectively communicating and summarizing experimental data.

The Automation Engineer designs, configures, tests, implements, and sustains automation solutions for formulation, DNA synthesis, manufacturing workflows, and production data systems at the Petaluma site. The role partners with Manufacturing, Quality, Operational Technology, Enterprise Information Technology, and external vendors to deliver reliable, maintainable, and compliant automation solutions. This position combines hands-on equipment and workflow support with software development, MES/LIMS integration, scheduling and batching automation, production data capture, and practical deployment of automation technologies that improve productivity, data integrity, operational efficiency, and manufacturing scalability.

Serán is expanding its Bend, Oregon campus with a new GMP manufacturing facility and is seeking a Commercial Quality Control Chemist to play a critical role in the facility start-up of the new QC laboratory including equipment and facility qualifications. Once the facility is underway, the Commercial Quality Control Chemist will be responsible for performing routine and non-routine analytical testing in support of commercial pharmaceutical manufacturing, including facility testing, finished product release, stability programs, in-process control testing, raw material testing, and other quality control activities as assigned. The QC Chemist I executes analytical methods in accordance with approved procedures, cGMP requirements, and Good Documentation Practices (GDocP), ensuring accurate, reliable, and timely generation of analytical data. This position supports the Quality Control laboratory through effective execution of testing, proper documentation, equipment operation and maintenance, data review, and participation in laboratory investigations and continuous improvement initiatives.

The Quality Control Department is seeking a microbiologist to support the Environmental Monitoring and Microbiology program. This role supports manufacturing through performing routine monitoring testing, utility testing, and cleaning process verifications testing. Work performed must be in accordance with US-FDA, EU and other applicable regulations. Preference will be given to those with regulatory knowledge and experience in a pharmaceutical manufacturing environment. Those with a background in microbiology and environmental monitoring in an adjacent industry are encouraged to apply.

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.

The Quality Control Inspector I ensures Company compliance in its programs to prevent or eliminate deviations in procedures and adherence to cGMP standards. Providing cGMP oversight and guidance to Operations and Logistics departments regarding quality related to documentation, inspection, and manufacturing/packaging processes.

This is a field-based position that provides on-site customer support for PacBio's revolutionary new third generation DNA sequencing platform. This person will install equipment at customer sites, ensure it meets performance specifications, and train operators on its use. They will be responsible for the ongoing repair, maintenance, and upgrade of the instrument at multiple customer locations. Consistent with a start-up environment this position will require flexibility in job responsibilities, travel, and assignments. The successful candidate will have superior customer management and technical skills in both engineering and science disciplines. They must be able to function independently but also work closely with development, manufacturing, and field sales and support teams. This will require a highly motivated individual, dedicated to deliver a best-in-class service experience to our customers. The position will entail several days per week of onsite instrument support at customer facilities.

We are hiring for Quality Control Chemist II, at our Minneapolis production facility in New Hope, MN. These testing technicians perform inspection on a range of work to detect defects and maintain quality standards.

The primary purpose of this position is the Quality Specialist (Inspection) will provide quality support of day-to-day Quality operations of all elements related to quality inspection within the Healthmark Quality Management System (QMS).

Responsible for managing the calibration system including ensuring calibration instructions are maintained, equipment is calibrated properly, and the completed calibration paperwork is reviewed and filed in a timely manner. Responsible for second level reviews of calibration certificates and BMRAM work orders. Perform equipment configuration verifications per established procedures.

We are looking for a meticulous and process-driven Biobanking Specialist to join our San Francisco team. In this role, you will be responsible for receiving, processing, and preserving irreplaceable human tissue samples that power our scientific programs. Every downstream experiment, every patient stratification insight, and every therapeutic program depends on the integrity and traceability of what you maintain. This is a 100% onsite role based at our San Francisco lab. You will be a foundational member of the biobanking function, ensuring that every donor sample is processed consistently, stored correctly, and captured with impeccable metadata. Donor samples are biologically unique and cannot be re-collected. A mislabeled specimen, a broken cold chain, or a documentation gap can permanently destroy material and compromise the scientific conclusions built on it. This role exists to ensure that never happens.

We are looking to fill a Scientist III - Cleaning Validation Analytical Chemist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer any sponsorship.

We are looking to fill a Scientist 3 -Analytical Chemist (Drug Substance Analysis) position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer any sponsorship.

We are looking to fill a Scientist II - Metrology Specialistposition working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clientslocatedinRahway,NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer any sponsorship. Metrology specialistis responsible for the oversight of regulated and non-regulated laboratory equipment. This role will oversee the lifecycle of the lab instrumentation covering acquisition and installation, performance or coordination of routine maintenance, computer system validation, and regulated systems retirement

The Manufacturing Associate I is responsible for executing GMP production of injectable pharmaceuticals while following all applicable SOPs. Manufacturing associates are responsible for preparing equipment and materials for GMP aseptic production and operating equipment such as glasswashers, autoclaves, depyrogenation ovens and automated filling machines.

The Scientist I position supports the efforts of the Process Development department within a fast-paced, expanding CDMO. This job will require extensive laboratory work, testing, and strategic client support of pharmaceutical development projects.

This position will have responsibility to support various activities in the Quality Control Laboratory. This includes testing the following sample types R&D, in-process, finished product, stability, as well as raw materials. Job duties may also include assisting in the performance of instrument validations, cleaning validations, and method qualifications as deemed appropriate by management

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 processes with interaction between production and cross-departmental engineering groups in resolving problems encountered on the production floor and across the business. Evaluates, selects, and applies exciting engineering techniques, procedures, and criteria, using judgment in developing and implementing adaptations and modifications on the production line and to quality systems.

As an R&D Engineer at Penumbra, you get to be hands-on, prototyping the next generation of medical devices! We are looking for someone who is excited to roll up their sleeves and relentlessly iterate on new ideas for electro-mechanical systems. You will work collaboratively to apply your passion for creative problem-solving at all stages of the design process, from concept to commercialization, which will have a profound positive impact on patients worldwide.

As a Project Controls Engineer, you will work collaboratively with clients, vendors, contractors, and other Project Farma Team Members to support projects related to biomanufacturing across the entire engineering lifecycle. You will apply your technical skills to meet project team and client needs for developing / maintaining project schedules and monitoring project performance. This work will include interfacing directly with project management, client management and site personnel for the development of detailed integrated schedules. You will be responsible for delivering high quality work, forming and maintaining valuable, long-term relationships with our clients, and continually strengthening your technical and industry knowledge.

The Project Controls Engineer will work collaboratively with clients, vendors, contractors, and other Manufacturing Solutions Team Members to support projects related to biomanufacturing across the entire engineering lifecycle. The Project Controls Engineer is responsible for delivering high quality work, forming and maintaining valuable, long-term relationships with our clients, and continually strengthening their technical and industry knowledge.

The Associate Scientist, Quality supports quality assurance and quality control operations for the insourced laboratory team as part of an End-to-End (E2E) Laboratory Modernization Program. Depending on assignment, this role concentrates in one or more of the following areas: CAPA and non-conformance management, document control, metrology and equipment calibration, records management and digitization, or personnel training and qualification. Because these functions operate as a single Quality team, staff routinely support one another across these areas as workload requires. This role operates within an ISO 17025 accredited analytical production laboratory at a client site. This is an entry-level position: the Scientist performs the activities above under direct supervision while developing foundational technical proficiency.

The Validation - Engineer I & II is an early-career professional responsible for supporting project execution through technical contribution, analysis, and problem-solving within defined scope and guidance. This role utilizes developing or intermediate technical expertise to solve complex problems, contributes meaningfully to project outcomes, and demonstrates increased independence in executing assigned work. Engineers are expected to build foundational skills, apply Project Farma methodologies, and deliver high-quality work products while collaborating across disciplines. This role requires sound judgment, effective prioritization, within established project frameworks, and continued growth toward greater ownership and technical proficiency.

This role offers the opportunity to gain experience in a fast paced cutting edge clinical lab environment. The Sample Accessioner will work in a team environment which includes project managers and clinical lab ops specialists. As an Accessioner, daily tasks will involve patient specimen intake, accessioning and fulfilling client requests for returns or destructions. This will entail following SOPs and working with Laboratory Information Management System (LIMS) and other software. This role will also perform shipping / receiving, recording and inventorying of samples sent for laboratory testing.

The System Specialist under Andover Site Technical Services (STS) Instrument Services (IS) provides technical support across instrumentation lifecycle activities in support of the Quality Control and Manufacturing Instrumentation Program at the Andover, Massachusetts site. The System Specialist will utilize their knowledge to provide technical support throughout the instrument lifecycle and support instrument qualification / upgrade, operation and maintenance programs, troubleshooting, performance issue resolution, reliability, periodic review / System Health Check, electronic data reconciliation, administrative, and decommissioning actions and deliverables for cGMP instruments and workstations used in the Quality Control Laboratories and GMP manufacturing suites. The System Specialist will also support technical and Continuous Improvement projects across the Site Technical Services, Quality Control Laboratory, and GMP Manufacturing team(s).

A Senior Associate Scientist (R2) position is available in the Conjugation Process Development group of Bioprocess R&D in USA - WA - Bothell. We’re seeking a passionate and creative individual to join a dynamic team of scientists and engineers focused on developing robust, scalable, and high productivity conjugation processes for the manufacture of antibody-drug conjugates (ADCs) for early- and late-phase clinical programs. The work will also involve working with commercial and clinical production facilities to ensure accurate technology transfer and successful large-scale production. You may also be involved in cutting-edge technology development projects that seek to discover new innovations for ADC process development and/or manufacturing.

The Manufacturing Associate I/II 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).

The Microbiology Associate II will be part of the Microbiology Department responsible for the testing and support for the Microbiology Laboratory in support of a Contract Manufacturing biotechnology facility and Process Development. Responsibilities include laboratory support, program testing, reporting of results, and execution of protocols.

We are seeking a motivated and detail-oriented Research Associate to join our Analytical and Formulation Sciences (AFS) team in Durham, NC. This role is ideal for those with experience in protein analytics, analytical methods development and qualification in a GMP laboratory. In this role, you will contribute to client-focused analytical projects by executing laboratory experiments, analyzing data, and collaborating with cross-functional teams to deliver high-quality scientific results.

When you work as an Associate Scientist in the BioPharma Sciences group at KCAS, you get to further our mission by applying your knowledge in bioanalytical and scientific principles to support study execution and development activities with increasing independence. You will contribute to study activities from setup through data generation while continuing to build your ability to assess data integrity and troubleshoot with guidance.

Are you detail-oriented and passionate about quality and compliance? Join our team as a Quality Assurance Specialist and help ensure the safety and integrity of life-saving plasma products. In this role, you’ll be a key player in upholding regulatory standards and supporting continuous improvement across the center’s operations. As a Quality Assurance Specialist, you’ll work closely with the Quality Assurance Manager and center leadership to monitor compliance, review documentation, and support training and audit readiness. Your work will directly impact donor safety and product quality.

The QA Specialist I provides quality oversight and compliance support for operations including equipment and material preparation, aseptic compounding, filling, inspection, and packaging activities. This role applies knowledge of cGMP and regulatory standards to review documentation, monitor processes, and support investigations. QA Specialist I collaborates with cross-functional teams to maintain compliance and contribute to continuous improvement initiatives.

Krystal Biotech, Inc is seeking a highly motivated Warehouse Associate to support operations at their Astra facility in Moon Township. The ideal candidate will take responsibility for inventory management, warehouse management, shipping and receiving while providing general support to the manufacturing and laboratory teams. Their efforts contribute to the overall success of an organization by ensuring that the right materials are available at the right time and in the right quantity. Effective communication, attention to detail, and a good understanding of supply chain dynamics are essential skills for individuals in this role.

The QC Chemist I will perform routine analytical testing of raw materials, in-process materials, finished products, and stability samples in support of oral solid dosage pharmaceutical manufacturing. This role independently executes assigned methods after qualification, operates commonly used laboratory instrumentation, and generates accurate, contemporaneous data in accordance with cGMP and Data Integrity requirements. The ideal candidate will demonstrate hands-on analytical laboratory proficiency, sound foundational scientific judgment, and the ability to perform routine testing accurately while escalating atypical results or technical concerns appropriately.

The Associate Biospecimen Project Manager will be the centralized point of contact to drive biospecimen lifecycle management and resulting analytical data from clinical studies for one of our sponsors, supporting the Biospecimen Management team. This position is part of Functional Service Provider (FSP) Solutions of LabConnect.

The QC Analyst is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

This role will be reporting to the Director of Project Management Regulatory. We are seeking a motivated, detail-oriented Project Manager to support the planning and execution of Cell & Gene Therapy development programs. Working closely with cross-functional teams, this individual will coordinate project activities, monitor timelines, facilitate effective communication, and provide administrative support to ensure projects are executed efficiently and meet key development milestones. This opportunity is well suited to an individual with early-career project management experience in the biotechnology or pharmaceutical industry who is eager to grow in a fast-paced, collaborative environment. The successful candidate will play a key role in project coordination, documentation, meeting management, and operational support throughout the product development lifecycle.

The CAR-T Operations Support Specialist will be part of the Technical Operations team responsible for the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team based on an assigned production shift schedule.

The Research Associate II performs a combination of routine and non-routine laboratory activities using molecular biology and cellular biology techniques to develop reference materials, support product development initiatives, and generate high-quality scientific data. This position works with moderate independence, contributes to project execution, analyzes experimental results, and collaborates with cross-functional teams to achieve departmental objectives. The Research Associate II is expected to demonstrate technical proficiency, troubleshoot routine issues, and maintain compliance with applicable quality and regulatory requirements.

The primary focus area and scope of this position is characterization of biological materials and providing support to manufacturing with timely and accurate in-process and final product testing. The business departments (outside the immediate team) that this role will be working closely with on a regular basis are manufacturing, disease state procurement, and materials management.

We are seeking a motivated and detail-oriented Associate Engineer / Engineer I to join our high-throughput Research Operations team. In this role, you will focus on hands-on material formulation characterization using synthesis techniques relevant to rheology, material chemistry, and mechanical properties. You will gain hands-on experience with state-of-the-art automation technologies while contributing directly to projects that drive our company’s growth. This is an excellent opportunity for candidates excited to learn engineering principles, work with advanced laboratory automation, and develop a strong foundation in scientific operations in a dynamic, shift-based environment.

We are looking for a hands-on and experienced Manufacturing Technician. In this role, you will perform routine running of manufacturing equipment to support production and R&D efforts. Furthermore, you will provide feedback to engineering and scientific staff on process performance and ideas for process improvement.

The Scientist I/II will be an integral member of the Targeted Therapeutics Group focused on generating novel antibody-based therapies for the treatment of cancers. The successful candidate will contribute to the design, synthesis, characterization, and optimization of antibody-drug conjugates (ADCs), degrader-antibody conjugates (DACs), and other targeted therapeutic modalities. This position offers an exciting opportunity to work in a fast-paced multidisciplinary environment advancing innovative cancer therapeutics from discovery through preclinical development, and into clinical development.

Responsible for Package Technology projects necessary to design, develop and transfer cost effective and sound packaging for pharmaceutical products. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, handling and tampering.

As an Electrical Engineer for Medtronic's Neuromodulation/Pelvic Health RPE you will be responsible for device electrical hardware design for market released implantable Neurostimulation devices and instruments. In this position, the candidate will be involved in all aspects of patient care device electronics used as part of a system to treat neurological disorders. The ideal candidate will have familiarity of low power electronics design, strong circuit analysis skills, test requirement specification development, and an understanding of test development. You will also be able to apply your knowledge of Six Sigma development methods, such as Design of Experiments (DOE), Concept Engineering (Pugh, AHP), Robust Characterization (P-Diagram), and Capability Analysis is a plus. This role involves collaboration with cross-functional partners such as reliability, regulatory, operations, and sourcing colleagues to evaluate and implement design changes.

The Test Engineer II supports verification and validation activities for complex medical device systems by developing test methods, executing system-level testing, designing test fixtures and automation solutions, and collaborating with cross-functional teams to advance products through the development lifecycle. This role contributes to system integration, design reviews, defect investigation, and validation efforts while helping ensure compliance with quality and regulatory requirements.

The Packaging Engineer II supports the design, validation, implementation, and maintenance of packaging systems for sterile and non-sterile medical devices. This role partners with cross-functional teams to execute packaging changes, support manufacturing and research initiatives, lead packaging validation activities, and maintain packaging documentation to ensure compliance, product performance, and operational effectiveness.

The Manufacturing Controls Engineer II will support both manufacturing engineering and controls engineering activities to improve equipment performance, manufacturing efficiency, product quality, and operational reliability. This hybrid role combines hands-on support for production equipment and manufacturing processes with technical expertise in automation, controls, and electrical systems. The ideal candidate will be a proactive problem solver who enjoys working across operations, maintenance, engineering, and supplier teams in a fast-paced manufacturing environment.

The successful candidate will provide technical support for the facility design, commissioning, qualification through technology transfer, validation and ongoing commercial manufacture of active pharmaceutical ingredients (APIs). In this role, you will work as part of a cross-functional team, initially supporting the capital project and transitioning to technology transfer and commercial manufacturing, while building technical expertise and contributing to operational excellence.

The Quality Control Associate provides support to the Bioanalytical Laboratory (BAL) staff for sample testing studies, including those performed under applicable elements of Good Laboratory Practices (GLP) and/or Good Clinical Laboratory Practices (GCLP), under direct supervision. This includes, but is not limited to, performing Quality Control review of study data and all laboratory and study-related documentation for accuracy and adherence to applicable plans, protocols, and policies.

The Quality Control Chemist at MilliporeSigma in Bellefonte, PA completes a variety of laboratory processes and procedures in the scheduling, evaluation, and review of stock and specialty chromatography products.

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 seek a Research Associate I to join our dedicated group of scientists. A desirable candidate will have the skills to culture mammalian and/or bacterial cells, perform DNA mini-preps, and complete bacterial transformations or cell transfections.

The Technician II, Fast Turn Pools is responsible for performing the synthesis and formulation of synthetic DNA according to the customer’s order. This generally includes synthesis, cleavage, deprotection, formulation, and final packaging of the products being made. This position reports to the Supervisor, is part of the Fast Turn Pools Value Stream located in Coralville, IA and will be an on-site role. Schedule: Monday - Thursday, 9:00pm-7:30am (shift differential applies)

A Technician II is a skilled manufacturing technician who is responsible for development and manufacturing of products tailored to a customer’s specific requirements. This position requires some experience and technical knowledge. Some required responsibilities include sets up and operates automatic or semiautomatic machines and related equipment in a continuous production/processing operation, formulating custom orders, operating laboratory equipment, following procedures and regulations, and taking quality control samples. This position reports to the Supervisor for that shift and is part of the Commercial and Regulatory Products – Plating & Replication value stream located in Coralville, IA and all work is performed on-site. Anticipated Schedule: Monday-Thursday, 9:00pm - 7:30am (Weekdays)

The Complaint Analyst is responsible for supporting product quality, safety, and regulatory compliance through effective management of customer complaints and post-market surveillance activities. This role partners with cross-functional teams to investigate product-related issues, support quality system processes, identify root causes, and drive continuous improvement efforts that enhance customer satisfaction and product performance. This position reports to the Quality Assurance Manager, Complaints and is part of the Quality Assurance Department located in Coralville, IA and will be an on-site role.

Contribute your technical manufacturing, equipment design and project management skills to a dynamic manufacturing engineering team creating precision instruments for minimally invasive robotic surgery. The role requires active participation in a manufacturing engineering organization in order to refine electro-mechanical components, assemblies, process documentation, tooling and test methods to improve efficacy, reliability, manufacturability and cost for surgical robotic instruments.

Iovance Biotherapeutics is an immuno-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL). The Aseptic Manufacturing Technician I, role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes. As an Aseptic Manufacturing Technician I, you will primarily be responsible for the following tasks: suite preparation for cell processing, material transfer, environmental monitoring, BSC runner duties, final product inspection, and final product cryopreservation in controlled rate freezers, for commercial and clinical use. This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to ensure the manufacturing process is completed. As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualifications, as well as ISO class 5 (Grade A) cleanroom operations is strongly desired.

Iovance Biotherapeutics is an immuno-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL). The Aseptic Manufacturing Technician I, role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes. As an Aseptic Manufacturing Technician I, you will primarily be responsible for the following tasks: suite preparation for cell processing, material transfer, environmental monitoring, BSC runner duties, final product inspection, and final product cryopreservation in controlled rate freezers, for commercial and clinical use. This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to ensure the manufacturing process is completed. As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualifications, as well as ISO class 5 (Grade A) cleanroom operations is strongly desired.

Iovance Biotherapeutics is an immuno-oncology company focused on the development and commercialization of novel cancer immunotherapies based on tumor infiltrating lymphocytes (TIL). The Aseptic Manufacturing Technician I, role is crucial for the autologous cell therapy manufacturing program. This position requires a broad understanding of theories, techniques, and principles to support manufacturing processes. As an Aseptic Manufacturing Technician I, you will primarily be responsible for the following tasks: suite preparation for cell processing, material transfer, environmental monitoring, BSC runner duties, final product inspection, and final product cryopreservation in controlled rate freezers, for commercial and clinical use. This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to ensure the manufacturing process is completed. As this person will be a key member of the autologous cell therapy manufacturing program, a background in cell culture, aseptic gowning and qualifications, as well as ISO class 5 (Grade A) cleanroom operations is strongly desired.

Iovance is seeking a highly motivated individual for the position of GMP Training Administration Specialist I at Iovance’s Cell Therapy Center (iCTC) in Philadelphia PA. This position is responsible for supporting the Technical Learning program and ensuring training is implemented in an effective manner at the site. In addition, this position will be responsible for providing training and guidance to users on Iovance’s electronic Learning Management System (LMS).

Perform routine laboratory testing and analysis of clinical trial specimens while ensuring compliance with established SOPs, regulatory requirements, and quality standards. Support laboratory operations through accurate documentation, sample management, result evaluation, and effective collaboration with internal stakeholders. Schedule will be Tuesday through Saturday (6:00pm to 2:30am)

The Scientist, Lab Operations is responsible for accurately executing laboratory experiments and contributing to the design of scientific procedures. This role supports scientific discovery and Good Laboratory Practices for the customer through laboratory testing, equipment operation, data analysis, and timely reporting.

Perform routine laboratory testing and analytical procedures in a regulated environment. Ensure accurate documentation, data integrity, and compliance with SOPs and regulatory standards while supporting laboratory operations.

As a Clinical Research Coordinator I (CRC I) at Iterative Health you will play an important role in the successful execution of clinical trials and the overall patient research experience. This role supports the coordination of day-to-day study activities while ensuring compliance with protocol requirements, regulatory standards, and patient safety guidelines. The CRC I works closely with patients, sponsors, CROs, investigators, and internal teams to help deliver high-quality clinical research and contribute to the advancement of innovative therapies.

Seek to improve the patient’s experience, never compromising on safety. Provide excellent customer service to patients and participants, healthcare partner and practice stat investigators, sponsors, and vendors. Operate as the lead Clinical Trial Navigator for at least one clinical study by owning the enrollment plan and strategies to achieve and exceed expectations. Execute the enrollment plan of assigned studies to meet requirement goals by identifying and contacting potential participants and screening to enroll into suitable studies. Build effective working relationships with colleagues, patients, investigators, and other internal and external partners on clinical trials. Support enrollment goals by contributing to patient retention strategies and building relationships within local communities. Ensure scientific integrity of data and record source data appropriately and accurately inclusive of patient visit data within source, CTMS, electronic reporting systems, completing the sponsor’s case report form, and timely query resolution. Ensure study documentation is up to date and audit ready, including reporting of adverse events and deviations with investigational products. Adhere to all Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), protocols, OSHA, proper PPE usage and other regulatory authority requirements. Conduct and document the informed consent process. Inform and educate the research team and healthcare system staff regarding study related procedures including IP dosing and monitoring requirements. Coordinate and schedule patient visits and conduct visits per protocols. Appropriately communicate and escalate to support responsiveness and resolution with our healthcare partners and other external stakeholders. Perform clinical and laboratory skills such as therapeutic area specifics, obtaining vitals, phlebotomy, EKGs, and collecting, processing, and shipping bodily samples. Demonstrate thoughtfulness around the immediate impact of your role on clinical trials. Demonstrate our Core Values such as fostering teamwork and collaboration and cultivating relationships with healthcare system representatives. Additional tasks as assigned.

The Associate Scientist, Sample Management, is part of the Analytical Development (AD) Proteins organization and is responsible for maintaining sample management system infrastructure, enabling right-first-time submissions, and coordinating efficient sample disposition to analytical laboratories. The Associate Scientist will partner closely with researchers, analytical testing groups, and cross-functional stakeholders to strengthen data integrity, reduce manual effort, minimize rework, and accelerate delivery of clean, decision-ready results.

The Manufacturing Process Specialist is a technical expert supporting the manufacturing of biological products both on the site and across the network. Provides technical expertise to ensure that atypical event and non-conformance investigations relating to production and the testing of materials and products are completed in compliance with all applicable procedures and regulations. Monitors and trends key process parameters. Troubleshoots manufacturing problems as required and provide primary technical support. Identifies and implement process improvements both locally and across the network. Supports capital projects, site wide initiatives or other projects as needed in the capacity of a project manager or a subject matter expert. Conducts technical and validation studies. This position requires strong organizational, communication and project management skills.

The Facilities Controls Engineer is to provide technical support for the facilities SCADA/BAS/BMS and electrical systems. This includes the camera and card access systems along with UPS systems, equipment, and controls projects at JHS-Spokane. The position may participate directly or assist others on project teams which are responsible for the design, acquisition, installation, and/or upgrade of critical systems and equipment used in the manufacture of pharmaceutical products. The Facilities Controls Engineer assumes responsibility for participation in capital and expense projects involving controls in facility or production equipment, cost reduction, process improvement, and/or compliance. In addition, the Facilities Controls Engineer will provide engineering support to include new construction support, process development, process optimization, and deviation investigations.

The Manufacturing Support Specialist is a full-time exempt role supporting GMP manufacturing operations at Kashiv BioSciences, LLC, Chicago, IL. The Manufacturing Support Specialist provides comprehensive administrative, operational, and quality-system support to the Manufacturing department, reporting directly to the Manufacturing Manager. This role is responsible for authoring and lifecycle management of GMP documentation, such as Batch Records (BR), Deviations (DEV), Corrective and Preventive Actions (CAPA), Change Controls (CC), and trainings in alignment with internal procedures and regulatory expectations. The Manufacturing Support Specialist plays a key role in ensuring compliant and efficient operations by partnering cross-functionally with Quality Assurance, Quality Control, MSAT, Engineering, and Supply Chain to drive timely closure of quality records, ensure data integrity, and support on-time delivery of manufacturing and quality milestones. This employee must maintain effective employee relationships, compliance with cGMP and other regulatory and SOP requirements, as well as environmental, health and safety obligations and company policies.

The Facility Engineer is a regular employee in a full-time exempt position at Kashiv BioSciences, LLC, in Piscataway, NJ. This employee will be responsible developing, testing, modifying, and creating solutions to technical problems.

Accurately weigh, measure, mix, and sterile filter cell culture media and buffer solutions within a cGMP environment. Strictly follow current Good Manufacturing Practices (cGMP), adhere to all standard operation procedures (SOPs), comply with all company policies, and data integrity standards. Execute associated batch records in real-time as well as associated supporting documents/logbooks. Ensure batches are executed in a timely manner and maintain proper documentation practices. Conduct routine sampling and support in-process testing and perform Daily in-process monitoring throughout batch duration. (pH, metabolites, cell density/viability). Use various analytical equipment such as pH meter, conductivity meter, osmometer, scales, etc. Performing equipment troubleshooting, cleaning, verification, and status labelling. Use of programs to collect, evaluate, and review operating data to conduct on-line adjustments to instruments or equipment. Ability to interpret and provide instructions furnished in written, oral, diagram, or scheduled format. Coordinate/support with the conduction of investigations and corrections for related issues during batch execution. Maintain good housekeeping standards in the work area. Following safety procedures specific to work area, including the proper use of personal protective equipment. Demonstrating dependability through good attendance and adherence to timelines and schedules. Perform other functions as required or assigned to support manufacturing operation.

We are seeking a highly motivated, attentive, and self-driven candidate to join our team, Biologics Pivotal Formulation and Process Development, as a Senior Research Associate. Once onboarded, the successful candidate will contribute in developing formulation and drug product processes for innovative molecules in pivotal clinical and commercial stages. The candidate will have tremendous opportunities for career growth in a fast-paced and resource-rich environment through training and professional relationships. The ideal candidate is expected to be action oriented with high expectations of themselves and others. They should have good verbal and written communication interpersonal skills.

Do you have a passion for helping bring innovative medical devices and drug delivery products to market that improve patient lives? Gilero, a Sanner Group company, is seeking an experiencedManufacturing Engineer to join our Pittsboro, NC location. Our Manufacturing Engineer will be responsible for planning, developing, implementing and maintaining manufacturing methods, processes and operations for new and existing medical devices under medical device regulations and standards (ISO 13485 and FDA 21 CFR Part 820). You will bring previous experience and understanding to work independently and with the cooperation from their teams to support and improve the manufacturing process through the effective use of materials, equipment and personnel.

The Associate Quality Engineer will be responsible for achieving the highest quality level of manufacturing quality and quality system performance while ensuring compliance with all company policies and procedures and maintaining compliance with US FDA and international medical device regulations and ISO 13485 quality system requirements. As a contributor to the quality engineering organization, this professional will be self-motivated and characterized as an excellent problem solver. This person will play an integral role in maintaining and improving the quality management system, product quality, and manufacturing process quality.

We're seeking a hands-on, detail-oriented Senior Research Associate / Scientist I to join our proteomics team and help scale our sample processing capacity. Sample volume is growing quickly, and we need someone who can take on the day-to-day execution of tissue and cell sample preparation and mass spec operation. Reporting to our principal proteomics scientist, you'll spend most of your time at the bench. You'll follow established SOPs closely, prepare and run high volumes of samples, and help keep our Astral mass spec calibrated, well-maintained, and running smoothly. This is a wonderful opportunity to gain hands-on training on the Orbitrap Astral Zoom + Vanquish Neo platform from an experienced mass spec scientist, and growing ownership of the workflow as our automated systems come fully online. This is a full-time, exempt, in-person position with work conducted at our Berkeley, CA location.

The OTS Specialist executes routine technical support activities for GMP Manufacturing Operations across multi-product, Manufacturing, Fill, and Finish CDMO facilities. Activities include cross-functional deviation investigations, CAPAs, AIs, targeted innovations, audit support, and overall plant performance. Support is for all local GRAM sites and the position works closely with Quality as well as Operations, Continuous Improvement, Engineering, MSAT, and Project Management to support site objectives. This is an on-site role. Must be able to work an on-call schedule for technical supports and site deviation analysis, as needed.

The Manufacturing Process Engineer executes technical tasks for GMP Manufacturing Operations in a multi-product, Formulation/Fill CMO facility including activities related to compliance, quality, targeted innovation, and plant performance and success. The MPE Contributes to solution strategies for new technical problems encountered during Aseptic Filling and Formulation/Prep. This position will support production activities on Saturday and Sunday. While ideal workdays are Friday, Saturday, Sunday, and Monday, flexibility exists surrounding workdays as long as weekend coverage is maintained.

The Process Validation Engineer or Specialist supports validation of cGMP equipment, facilities, and processes. These duties will include but are not limited to: validation of manufacturing processes and production equipment.

Senior Product Development Engineer possessing strong technical judgment and a deep understanding of customer centric design to support new product development from concept to production.

Product Development Engineer 2 possessing strong technical judgment and a sound understanding of customer centric design to support new product development from concept to production.

Product Development Engineer 2 possessing strong technical judgment and a sound understanding of customer centric design to support new product development from concept to production.

As a Systems Design Engineer at HighRes Biosolutions, you will be heavily involved with all elements of our custom systems product life cycle. You’ll work closely with the sales and applications team to turn a customer’s needs into an automated solution. Additionally, you’ll work closely with the operations team to turn your designs into fully functional systems. The systems you design will be used by top pharmaceutical and biotech companies around the world to help improve human health. The qualified candidate will have strong design capabilities with SolidWorks. A product development background for lab, medical or consumer products is beneficial.

The Industrial Engineer will lead and manage challenging cross-functional projects to deliver exceptional customer service world class and distribution performance. The Industrial Engineer focuses heavily on implementing lean practices throughout each work center in the distribution center as well as assessing and deploying technology solutions to enable scale, efficiency, and accuracy.

As an optical engineer at Horizon Surgical Systems, your work will contribute to the design and development of an automated robotic platform for ophthalmological surgery. In this role, you will assemble, test, calibrate, and maintain multimodal digital surgical microscopes, comprising multiple incoherent illumination and digital microscopy channels as well as an integrated Optical Coherence Tomography (OCT) system.

The Automation Systems and Design Engineering (ASD) team is part of the Process and Automation Engineering (PAE) group within the Manufacturing Technology and Transfer (MTT) organization. This functional team has the responsibility for enabling new and existing manufacturing operational capabilities through the design, development, and support of manufacturing equipment systems. As a Design Engineer, you will leverage your experience and design knowledge to create solutions to manual, semi-automated, and automated manufacturing problems for Illumina consumables. In addition, you will own and support the deployment of various design solutions to NPI programs throughout the planning, requirements, specification and design, verification, validation and production release phases of capital equipment projects.

As a Systems Integration Engineer 1 at Illumina, you will work in a collaborative, team‑oriented environment to help develop and test genomic analysis tools at the leading edge of research. You will contribute to the delivery of high‑quality, robust products through the integration of hardware, software, chemistry, and biological assay components. A key aspect of this role is executing structured experiments, diagnosing complex system‑level issues, and collaborating with cross‑functional teams to drive problems to root cause.

Execute routine manufacturing tasks following SOPs and GMP requirements. Prepare buffers, reagents, and solutions for production. Maintain accurate batch records and documentation. Operate and monitor basic and semi-automated manufacturing equipment. Assemble, label, and package diagnostic kit components. Support ELISA processes such as plate coating and reagent preparation. Maintain clean work areas and comply with safety and quality standards.

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 set up 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.

INCOG BioPharma is seeking a highly motivated individual with subject matter expert (SME) capabilities in sterile pharmaceutical manufacturing process controls and industrial automation. The Equipment Specialist is a key technical role within INCOG BioPharma Operations. This candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, or within highly regulated industries. The Equipment Specialist’s primary responsibility is to efficiently and safely set up 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 primary purpose of this job is to execute and support the Complaint Handling, Regulatory Reporting, and Post Market Surveillance processes for Integer under the direction, instruction and guidance from more experienced associates and managers in your organization. This position will be responsible for executing and providing support in the analysis, evaluation and product investigation of complaints received from external customers in a timely manner to comply with FDA 21 CFR (QSR) requirements and requirements of other regulatory bodies and countries with some instruction and guidance from more experienced associates and managers.

As an EHSS Engineer, you will have the opportunity to work in a culture of EHSS excellence driven by associate engagement. The primary purpose of this position is to support systems and drive execution of programs to effectively maintain a safe workplace and ensure compliance with all applicable Environmental, Health, Safety, and Security (EHSS) regulations.

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.

Follows defined test plans and datasheets with necessary supervision/support. Evaluates test performance and sample operation to properly evaluate test results. Records and explains test results and completes test report. Serves as Lead for simple test programs as assigned with the necessary assistance. Communicates project status and results as needed. Holds responsibility for defining test plan, report completion and accuracy, meeting of agreed deadlines, and managing project related activities. Examines customer samples and learns to operate appropriate tests for each case with support. Communicates with internal customers during setup and operation to ensure proper evaluation. Directs, builds and/or adapts simple test setups, sample preparations/solutions and instruments to new situations, based on test plans and instructions. Trains other lab staff on these test procedures or instruments. Operates and maintains test instruments appropriately to measure and test samples. Performs maintenance on designated test instruments and laboratory area. For a single testing technology, integrates basic process and instruments improvements into all aspects of the job. Communicates with management and technical staff to provide suggestions for new instruments, processes, and forms to improve accuracy and efficiencies. Understands and follows safe chemical hygiene practices. Read and follow the Underwriters Laboratories Code of Conduct, and follow all physical and digital security practices. Other duties as assigned

Supports product testing and certification projects by conducting technical evaluations, coordinating lab testing, and ensuring compliance with UL standards. Works directly with customers, manages project timelines, prepares reports, and provides technical guidance throughout the certification process.

Under general supervision, manages execution and timely completion of basic engineering projects by analyzing project scope and determining project specifications, establishing test programs for product investigations, analyzing test programs for adequacy and sequence, examining samples for compliance with UL requirements, and preparing reports for clients with supervision. Assists in the development of UL requirements, test methods, and test equipment. May exercise Project Handler Signature Authority as Project Handler of record responsible for opening, maintenance, completion, and closing of assigned new work engineering projects.

We are seeking a highly motivated Scientist II with strong expertise in cell biology and hands-on experience in advanced in vitro models to support the development and execution of cutting-edge Organ-Chip studies in the neuroscience area. This role is ideal for a scientist who thrives in a fast-paced, collaborative, and innovation-driven environment and is excited to help shape the future of human-relevant research and drug discovery.

As a key member of the Quality Assurance department you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. Performs activities for sterilization validations (gamma, VHP and H2O2 gas plasma). Performs activities for processing of reusable devices (cleaning, disinfection, sterilization). Generates protocols, coordinates with test labs, and authors technical reports. Manages dose audit program and annual sterilizer requalification. Support product development for new implants for sterilization and cleanliness evaluation, including define testing strategies. Routine monitoring and control of water system, ISO Class 7 cleanroom environmental monitoring and product bioburden. Reads and interprets microbiological cultures and other tests including environmental monitoring, sterility tests, chemical characterization, cytotoxicity testing and microbial assays. Support process or design changes for existing products and supplier changes for sterilization, cleanliness and processing evaluation, including define testing strategies. Assures compliance to FDA and ISO standards. Assists in generation and response for regulatory submissions. Perform other job duties as needed

The Microbiology Technician is primarily responsible for the manufacturing of bacterial control materials used in microbiology staining applications. This includes culturing, harvesting, and processing bacterial organisms into finished control products in compliance with ISO 13485 and applicable regulatory requirements. When not engaged in bacterial control production, the technician supports the Quality Control laboratory by performing application/performance testing of stains and reagents, as well as any additional testing assigned by laboratory leadership.

Understand and follow Quality System documents relevant to responsibilities, e.g., Quality Manual, SOPs, and Methods. - Adhere to appropriate quality measures to meet or exceed the standards set by ISO/IEC 17025, government regulatory (cGMP, GLP), and company requirements relevant to assigned duties. - Adhere to all health, safety, and environmental regulations relative to assigned analytical work; maintain and assist others in maintaining a clean, safe work environment. - Demonstrate proficiency in at least one core method and ability to conduct at least one other assigned method with no more than 25% supervision. - Demonstrate ability to operate all required basic lab equipment within department. - Set up batches of samples to weigh and weigh samples. - Perform timely and accurate analysis of samples to meet customer commitments, including but not limited to, preparing samples for analysis, using appropriate analysis methods and techniques, and applying appropriate data reduction. - Maintain a neat and accurate record system; keep accurate records of work performed on a daily basis and as needed for quality control tests or regulatory purposes; record test data and results for samples in logbook, record book or BookMaster and enter the data or results into eLIMS either manually or through automatic export. in a timely and accurate manner. - Identify from samples assayed the need for rechecks. - Maintain clean glassware and prepare solutions for use in the daily testing of assigned samples. - Identify method/matrix/analytical difficulties and report these together with proposed solutions to Department Leader or supervisor. - Ensure that proprietary methodologies are not disclosed to non-employees except as approved in writing by the Laboratory Manager or appointed designate. - Maintain a perpetual state of readiness and willingness to respond to the queries and needs of clients, staff, and co-workers. - Remain current on technical, industry, and business advancements and trends as suggested by the Department Leader or supervisor. - Recommend more accurate or efficient laboratory equipment or procedures. - Maintain cooperative working relationships with all company employees. Communicate orally and in writing to co-workers. This includes “intra” and “inter” departmental employees. - Promote the company image through the exercising of sound and ethical business practices as related to the public and our customers. - Perform other related duties as assigned.

The Quality Specialist provides operational support for the Quality Management System, supporting compliance with ISO 17025 and other applicable standards through documentation control, audit readiness, record management, and routine quality assurance activities.

Eurofins PSS is looking for new team members for our team to help support and join our diverse team to help assist on scale up and manufacturing of mammalian and microbial fermentation/purification processes for clinical and toxicology supplies.

The Packaging Engineer I is responsible for providing technical oversight of pharmaceutical packaging operations at Contract Manufacturing Organizations (CMOs). The qualified candidate will have technical knowledge of packaging operations and have some experience in overseeing pharmaceutical packaging operations at external CMO’s. Additionally. the qualified candidate will possess excellent interpersonal skills to effectively work in a team-based environment.

Under minimal supervision, this position is responsible for operation of pharmaceutical manufacturing equipment in a GMP environment for the purpose of making clinical supplies and performing development experiments. Incumbent is also responsible for leading manufacturing activities in assigned production rooms.

To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add an Associate Production Supervisor located in Austin, TX. Reporting to the manager the potential candidate would be in charge of directing the manufacturing operations performed in a shift or group of production lines, ensuring they reach volume, quality and cost goals.

The Associate Scientist I engages in process development activities on a full-time basis and applies basic concepts of purification under close supervision. This person is expected to work closely with cross-functional teams to support in the development and optimization of AAV purification processes, data analysis and summary reports on a timely basis while maintaining compliance and readiness.

At Freenome, you will help develop the assay technologies used to analyze patient samples and contribute to our mission of early detection and intervention in human disease. As a Research Associate I/II, you will provide experience in next-generation-sequencing (NGS)-based analyses of DNA. Starting with a prototype assay, you will contribute to developing and validating clinical-grade assays to measure complex, blood-based analytes. You will work closely with multiple teams including molecular research, computational science, automation engineering, and clinical operations to develop the assays in a regulated, high-throughput environment as well as identify ways to rapidly iterate and improve on existing methods to evaluate technologies that can enhance our end-to-end test performance.

Laboratory Application Specialist-Large Molecule — a role that is to support lab operational and studies in a regulated (GLP/GCLP) research environment, including but not limited to documentation and data archival, sample handling, and other activities to support the studies. This role will support project PIs (principal investigator) with documentation, and coordination tasks, sample handling, ensuring compliance with GLP/GCLP standards and efficient study progression from setup to completion.

Independently develop and maintain Central Lab Service standard procedures and training Job-Aids regarding LIS/LIMS, middleware, and other supporting software Systems. Build and maintain LIS/LIMS database for clinical trials, medical diagnostic testing, and Biorepository. Partner with Laboratory Operation and Project Management to build appropriate tests and calculations in central lab LIS/LIMS systems. Assist laboratory management and QA Specialist with comprehensive Change Control related to the Laboratory Information Systems. Liaise between laboratory management, QA, and Information Technology departments, coordinating multidisciplinary efforts. Ensure Central Lab Services instruments and systems follow relevant regulations and requirements (HIPAA, GDPR, GCP, GLP, CAP, CLIA, etc.) in conjunction with QA and laboratory management. Work with Data Management team to ensure uniformity and accuracy between LIS/LIMS and client data transfer agreements. Build and maintain multifarious, protocol driven, studies within LIS/LIMS databases in accordance with the appropriate Study protocol and Laboratory manuals to ensure all client needs are met. Identify, analyze, and take corrective action for technical difficulties with LIS/LIMS databases experienced by Laboratory personnel or clients. Assist Bio Analytics Sample Management team with study design and sample login within the WATSON system or LabVantage Administrate users and security of central lab systems. Document LIS system related incidents and resolutions in IT support ticket system or logbooks. Timely communicate with supervisor on workload and prioritize tasks according to project timelines. Other tasks as assigned.

Performs routine and non-routine microbiology sample analysis (specifically, MLT/Bioburden, Endotoxin, Environmental Monitoring, Sterility, and AET) and a variety of tasks to support product development, ensuring agreed timelines.

BreezeBio is seeking an organized, hands-on Lab Operations Associate to keep our biology, chemistry, and shared laboratory spaces stocked, organized, and running smoothly. This is an onsite, part-time role centered on laboratory procurement, receiving, and inventory, along with day-to-day support that keeps our lab spaces in good working order. You will work closely with the Principal Operations Manager, who oversees broader laboratory operations, facilities, EHS programs, and regulatory strategy, and who will be your point of escalation for anything outside the scope of this role. The ideal candidate is detail-oriented, dependable, comfortable working in an active laboratory environment, and willing to take a hands-on approach to keeping laboratory spaces organized and functioning efficiently.

Genezen is seeking a Manufacturing Technician I to play a hands-on-role in the production of clinical and/or commercial cell and gene therapy products, helping our partners deliver life-changing advanced therapies to patients. This role is responsible for performing routine and non-routine manufacturing operations in a cGMP environment, including process execution, in-process controls, equipment operation, and documentation, while working closely with MSAT, QC, QA, Engineering, and Validation teams to ensure safe, compliant, and high-quality manufacturing operations.

The Bruker AXS-EM division is looking for an electromechanical technician to do board level debugging of PCBs on our electron microscope products. Bruker AXS-EM electronics span a wide range from high-speed digital cameras and scanning systems to ultra stable precision current supplies to 200kV high voltage supplies with tens of millivolt stability. The successful candidate will be able to handle multiple projects simultaneously, making sure that things come together in a timely manner. Help others as needed. Responsibilities will shift and grow based on ability and interests. Light travel to Asia and Europe is a possibility but not a requirement.

As a Manufacturing Technologist, you'll work in our production department with a team of technicians and engineers responsible for manufacturing the Hysitron product line of instrumentation. This position offers the opportunity gain hand-on skill with cutting edge technology and opens the door to an exciting future in mechanics and engineering. Under the appropriate guidance, you will be responsible for building electro-mechanical components and devices that are used in our line of nanoindentation products. You will have opportunities to work with advanced scientific tools including the Hysitron scanning probe nanomechanical test systems.

Regulatory Operations owns the “how” of regulatory work — the systems, data, publishing pipeline, and registry interfaces that let RA Specialists focus on strategy, dossier content, and agency engagement. The Regulatory Operations Specialist is the hands-on execution role within that function: maintaining the registration data everything else depends on, publishing and transmitting submissions to required standards, and keeping trackers, archives, and correspondence logs accurate and audit-ready. The role is expected to be the dependable operational backbone of the RA team.

The Manufacturing engineer is responsible for activities that include but are not limited to design, simulation, building, test and documentation to develop and/or maintain/ improve production tools and test equipment for the manufacturing of products for ophthalmic surgery. This also includes the development and improvement of production processes and related documentation. All activities need to be carried out in conformity with international regulations, safety and performance standards as applicable.

We currently have an opening for an Associate Design Quality Engineer for the Vascular division. This role is located at our Temecula, CA location. This is a fully onsite role. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

Develop, constructs, tests, and maintains data architectures such as databases and large-scale processing systems, where the focus is on infrastructure and data flow management. They are responsible for building & maintaining data pipelines (ETL processes; ensuring data quality & reliability; designing and managing data warehouses and databases; and integrating data from various sources. Data engineers create the systems and structures that allow data to be collected, stored, & processed efficiently

Research Associate IIs (RAIIs) are responsible for performing various techniques that include, but are not limited to, staining and scanning of formalin-fixed paraffin-embedded tissue, formalin-fixed paraffin-embedded tissue macro-dissection, RNA/DNA extractions, assays for nucleic acid quantification and QC, PCR and real time PCR, Next Generation Sequencing, protein extraction, assays for protein quantification and QC, western Blotting, ELISA and ELONA, sample preparation for mass spectrometry, aptamer selection, biomarker discovery / target ID, affinity purification, immunoprecipitation, proximity labeling assays, cell culture, cell growth and viability assays, cytotoxicity assays, and immunocytochemistry.

This position is responsible for performing clinical specimen accessioning, sample sorting, and data entry in a fast-paced, high-throughput environment. Evaluates the needs of internal and external clients to provide high-quality customer service. Provide support as needed and defined by those to whom the position reports. Adhere to and ensure compliance with the Company's policies and applicable standard operating procedures. This role will spend the most time performing data entry login of specimen-related details, accessioning samples into the laboratory information system according to the given protocol with minimal errors and scanning requisitions with all related paperwork, and accurately labeling specimen(s)/slide(s) and ensuring timely distribution to the appropriate areas.

The Senior Associate Scientist I performs work that is varied and that may be somewhat difficult in character but usually involves limited responsibility. Some evaluation, originality or ingenuity is required. Follows established protocols and work plans. May be assisted by laboratory technicians/assistants. Comply with divisional and site Environmental Health and Safety requirements.

Catalent Pharma Solutions in Madison, WI is hiring Facilities Engineer. This position will work on complex facility-related problems requiring in-depth data analysis to determine appropriate action. The Engineer is expected to have extensive ongoing communication with employees and cross-functional group managers/departments on facility-related issues.

This is an entry level position in the Manufacturing team and is the starting point to acquiring skills and training required for a cGMP biomanufacturing environment. The Technician is responsible for the manufacture of biopharmaceutical products within a clean room environment. The position is expected to follow detailed instructions and established procedures with frequent supervision.

Headquartered in Ann Arbor, Michigan, Cayman Chemical Company supplies scientists worldwide with the resources necessary for advancing human and animal health. We offer a vast product catalog that is constantly growing to meet the needs of our clients. Additionally, we provide service programs that include comprehensive solutions to drive clients’ projects to completion. Our mission is to make research possible. That starts by employing a talented and highly qualified group of experts that develop the tools to support research scientists. Currently, we are looking to add a GMP QC Chemist I to the team

We are seeking an innovative and highly motivated Manufacturing Support Services Specialist to join our Operations team who will contribute to the manufacture of our advanced cell therapy manufacturing platform. The primary focus of this position will be to support manufacturing operations, as well as day-to-day warehouse operations. This is a hands-on position that will train in the Manufacturing and Warehouse Team. 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.

Cellares is seeking an innovative and highly motivated Scientist with expertise in cell therapy manufacturing to join the Process Development team. This individual will interface across many parts of the company and contribute significantly to the development of our advanced cell therapy manufacturing platform. The primary focus of this position is to design and execute experiments that drive the continuous improvement of the Cellares platform. The ideal candidate will be a strong technical contributor and cross-functional collaborator with demonstrated experience developing robust autologous and allogeneic cell therapy processes. Candidates should also enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

This role is responsible for maintaining quality systems, tracking and reporting QA metrics, managing laboratory documentation processes, and ensuring adherence to FDA GLP requirements while partnering with cross-functional teams to drive continuous improvement and quality excellence. The ideal candidate is detail-oriented, highly organized, and capable of working independently and collaboratively to support the integrity, accuracy, and compliance of quality operations across the organization.

Cellipont Bioservices is growing, and we are looking for a QA Technician II, Operations who believes in the potential of bridging client's discoveries to patient cures and who wants to challenge the status quo and take Cellipont and its clients to the next level. The QA Technician II, Operations will be responsible for monitoring systems and procedures to ensure compliance where applicable. The QA Technician II, Operations is responsible to provide Quality Assurance support real-time for GMP Manufacturing of master/working cell banks. This individual will be responsible for providing QA on the Floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other QA functions as needed.

The Mechanical Engineer is responsible for applying engineering principles to the planning, design, development, documentation, testing, troubleshooting, and continuous improvement of automated manufacturing equipment, instruments, systems, and related processes that support reliable production performance. This position reports to the Sr Manager, MFG Automation Engineering, Tuesday - Sunday, 9 pm- 5 am, and is part of the MFG Automation Engineering department located in Lodi, CA, and will be an on-site role.

A Technician I – Histology is in training to perform and become proficient in on-boarding skills, procedures, and cooperating in a team environment. The technician is learning basic skills required to conduct a study, which may include handling tissues and organs, trimming tissues, embedding, measuring organ weights; microtomy, slide preparation, staining; inventory and quality control, and shipping of tissues. The technician is working under close supervision to gain proficiency.

This position will be responsible for handling and processing samples and performing accurate data collection and reporting. Basic methods will be used to perform laboratory tasks with minimal supervision in the performance of studies. Performs technical laboratory activities in support of client studies or procedures. Performs analysis of data for quality and completeness and determines if results are as expected. Records data in compliance with company and regulatory policies and standards to meet quality and accuracy requirements. Executes scientific testing strategies and studies. May participate in development as part of team. May lead assay research, assay validation or study conduct, or is involved in preparation of material (e.g. protein, nucleic acid, cells, etc.). Reviews and interprets study data, communicates results to clients and writes final reports. Ensures compliance with protocols and all applicable SOPs. Troubleshoots and resolves assay or technical issues in the laboratory when scientific expertise is needed. Contributes to specific dataset interpretation, or when appropriate answering questions from regulatory authorities. For singular focus of Chemistry or Biology disciplines, refer to specified role on job architecture.

Third-shift role responsible for operating and troubleshooting LC-MS/MS instruments to support daily schedule. Performs technical laboratory activities in support of client studies or procedures. Performs analysis of data for quality and completeness and determines if results are as expected. Records data in compliance with company and regulatory policies and standards to meet quality and accuracy requirements. Executes scientific testing strategies and studies. May participate in development as part of team. May lead assay research, assay validation or study conduct, or is involved in preparation of material (e.g. protein, nucleic acid, cells, etc.). Reviews and interprets study data, communicates results to clients and writes final reports. Ensures compliance with protocols and all applicable SOPs. Troubleshoots and resolves assay or technical issues in the laboratory when scientific expertise is needed. Contributes to specific dataset interpretation, or when appropriate answering questions from regulatory authorities. For singular focus of Chemistry or Biology disciplines, refer to specified role on job architecture.

This role provides hands-on engineering support for manufacturing and facilities operations within a rotating engineering environment. The Engineer II supports drug substance manufacturing equipment across upstream, downstream, and facilities engineering functions, contributing to technical troubleshooting, equipment lifecycle management, validation activities, capital projects, and technology transfers in a regulated GMP environment.

Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations – each playing a critical role in delivering our therapies to the patients who need them. Our teams are organized by the steps in the biomanufacturing process that they operate in; including – Upstream (Cell Culture), Downstream (Purification), and Media & Solution Preparation. Manufacturing Associates perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP).

BioLegend has an exciting new opportunity in our Custom Solutions team for a life science graduate with 1-3years’ experiencein the biotech or pharma industry. The Custom Project Coordinator will help coordinate product manufacturing plan and contribute to BioLegend’s mission of providing legendary customer service. This role offers broad cross-functional exposure across the business, serving as a primary point of contact for key customer accounts — including VIP clients and biopharma partners. High performers will find meaningful opportunities for career growth, with pathways tailored to individual strengths and areas of specialization.Thesuccessful individual will demonstrate high attention to detail, strong problem-solving skills, and ability to stay on top of multiple projects using project and customer management software.

BioLegend is seeking a highly motivated Product Development Research Associate to join our Diagnostic Product Development Team. This position will actively participate in the development of flow cytometry reagents for diagnostic use. The responsibilities include: perform experiments, analyze and report results, troubleshoot, manage and maintain documentation. After three months in this role, you should be able to work independently to perform flow cytometry experiments, analyze data and document report. We are open to considering candidates at Research Associate I, II, or III level.

BioLegend is seeking a highly motivated Manufacturing Biotechnician to join the Biomarker Immunoassay team in San Diego. ELISA Manufacturing Biotechnician will be working closely with others in the team to ensure timely manufacturing of high-quality immunoassay products under ISO13485 standards. This role will be responsible for all aspects of product manufacturing including follow production plans, product preparation, making and occasionally testing immunoassay components and kits, in addition to documenting and reviewing production batch records to ensure accuracy and completeness.

Under the supervision of the laboratory supervisor the Microbiologist I provides a high level of quality pharmaceutical microbiology testing as well as effective customer service to ARL Bio Pharma clients. This is a safety sensitive position as defined by state and federal laws that will require working with hazardous materials and/or handling medicine.

Biolinq is seeking a highly motivated, energetic team-player to be a research associate with the drive to deliver results in a fast-paced innovative space. The candidate will join a close-knit and dynamic team working on the leading edge of wearable biosensor science. They will contribute to the design, synthesis, and assessment of next-generation aptamer-based electrochemical biosensor architectures. They will be expected to contribute to ongoing research, make extensive use of proper laboratory practices, including preparing solutions, running experiments, and recording data. Location will be Biolinq's corporate headquarters in San Diego CA.

We are seeking a detail-oriented Lab Technician to join our laboratory team. Reporting to the Laboratory Operations Manager, this role is responsible for supporting the end-to-end processing of customer samples, including laboratory preparation, microbial and DNA-based analysis, and data entry. The Lab Technician plays a key role in ensuring accurate, timely, and compliant sample processing while maintaining laboratory operations, equipment, and inventory. This position requires strong organizational skills, hands-on laboratory experience, and the ability to work efficiently in a fast-paced, regulated environment while supporting both internal teams and customer needs.

We are seeking a full time direct hire QC Analyst to report to the QC Manager. You will be responsible for supporting analytical testing activities related to method transfer, verification, and qualification. The QC Analyst ensures all work is executed in accordance with established procedures, protocols, and regulatory requirements. This role requires close collaboration with the Lead QC Specialist, Manufacturing teams, and scientists within the Analytical Development group. Additionally, the QC Analyst will work cross-functionally across the site and interface with Bionova clients to ensure that laboratory results are accurate, reliable, and delivered in a timely manner.

As a Quality Control Specialist I, you will perform a broad variety of basic (particle, stability, shelf-life, conductivity, pH) and advanced testing of raw materials and functional testing of finished goods. Depending on the type of production the testing may be conducted on assays, reagent or instrumentation. Conduct microbiological tests, including environmental and sample monitoring. Read and interpret microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion and microbial limits tests. Perform first article testing, troubleshooting, root cause analysis and feasibility/capability studies. Identify materials that are out of spec or tolerance, issues appropriate notifications and maintains batch records.

Provide regulatory support for IVD products with multiple product groups with clinical diagnostics. Assembles low to medium complexity regulatory submissions to support world wide product registration change requests for IVDR. Basic analytical, communication, problem solving, and critical thinking skills to meet daily job responsibilities. Interface daily with desktop publisher, technical writers and regulatory specialists. Work collaboratively with R & D, QA, Planning and Manufacturing teams.

The responsibilities of this position (Scientific Support Associate, SSA) are to respond to incoming technical inquiries and basic complaints by providing technical assistance on Protein Simple brand instrumentation, software, and applications, with a focus on first-class customer experience. Additional responsibilities will include maintaining technical resources and continual training to stay current on technical information for old and new products. Perform additional duties as assigned.

Perform routine quality control testing to determine lot status and product release for the ProteinSimple capillary electrophoresis basis systems, including iCE and SimpleWestern. This position is responsible for planning, executing, and managing activities in the ProteinSimple liquid and lyophilized reagent QC process to ensure that all applicable objectives are met, and the product functions as expected. To be successful in this role candidate needs to be skilled in analytical techniques for analysis of biological assays. This position interfaces with Manufacturing, Process Engineering, Product Support, Assay Development and Quality Assurance.

The Quality Technician role is established to support the Simple Plex and Simple Western Consumables team in the Wallingford facility. Assists Quality Analysts and the QA team in our ISO compliant environment. Provides support for QC / QA activities including hands-on evaluation of microfluidic cartridge products and simple western cartridges (see https://www.proteinsimple.com/ella.html).

The Engineer I provides product and process engineering support throughout the product’s lifecycle to meet requirements of Good Tissue, Manufacturing and Laboratory Practices (GTP/GMP/GLP). This role primarily contributes to the development and maintenance of medical device Risk Management Files throughout the product lifecycle by ensuring risk management activities and documentation are maintained in compliance with applicable standards and company procedures. This role also focuses on maintaining product quality, reliability, regulatory compliance, and manufacturing efficiency by leading engineering investigations, implementing design changes, resolving technical issues, and driving continuous improvement initiatives. This role collaborates closely with technical services, manufacturing, quality, donor services, regulatory, commercial, medical affairs and external suppliers to ensure uninterrupted product supply while meeting applicable regulatory and quality standards.

The Manufacturing Associate I, Cell-Based Manufacturing, supports the production of cell-based reagents, assay components, cell culture media, and production of cell lines used in cell-based assay manufacturing. This role is responsible for preparing and formulating reagents and media, performing routine mammalian cell culture activities, supporting cell line expansion and banking, and quality control testing to ensure materials meet established specifications.The ideal candidate is detail-oriented, dependable, and comfortable working in a fast-paced, quality-driven laboratory manufacturing environment. This position requires strong documentation practices, careful execution of procedures, good organizational skills, and the ability to work collaboratively with QC, QA, and R&D teams. All work must be performed in accordance with applicable procedures, safety requirements, and ISO 9001:2015 quality system expectations.

The Manager; MOA will be part of a collaborative data science and business insights team dedicated to answering key business questions for the Product Development and Supply (PDS) business units, and will report to the Director; Manufacturing Optimization Analytics. The Manager will develop advanced data analytic tools and AI to answer business operations and strategy questions for the member functions that enable end-to-end product development, manufacturing, and distribution activities. The successful candidate has a scientific background in life sciences or engineering and has expertise in one or more of the following areas: data analytics, data visualization, statistics, machine learning, predictive modeling, decision analysis under uncertainty, artificial intelligence, Python and/or R, app development, and PowerBI dashboard development. Additionally, the successful candidate is an exceptional communicator with excellent presentation and writing skills, and is able to manage multiple priorities and projects.

Reporting to the Quality Control Supervisor – Isotope Production, the associate scientist will execute testing in the Quality Control laboratory which supports RayzeBio’s Isotope Production process in Indianapolis. This position will conduct inspections and testing of raw materials, in-process controls, and finished products, ensuring compliance with specifications and regulatory standards. Specifically, the Associate Scientist will support the release of isolated isotopes manufactured at RayzeBio in support of clinical and commercial drug programs.

The Operator – Isotope Production will be an integral part of bringing RayzeBio’s innovative drug products to patients in need. As Operator within the Isotope Production department, you will be instrumental in the day-to-day execution of an isotope production program that will manufacture the clinical and commercial scale radioisotopes for RayzeBio’s drug products. This individual will be part of a team responsible for producing RayzeBio’s isotopes under Good Manufacturing Practices (GMP). Additionally, you will be the front line in ensuring compliance with radiation safety requirements on the production floor. This position will report to the Supervisor – Isotope Production. Operator level will be evaluated with experience and qualifications.

Our Manufacturing Associate, Cell Therapy team manufactures human blood derived components per Batch Record and Standard Operating Procedures in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned, production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable.

The Scientist II Production role will learn all aspects of the adeno associated viral (AAV) vector production. They will master procedures and be able to lead and coordinate their execution. The Scientist II will be responsible for adhering to cGMP principles while overseeing production teams in the production of AAV drug substances. They will work with Management and Senior Staff to plan and execute operations goals.

We are seeking a Laboratory Technician to join our team, reporting directly to a supervising scientist or research associate. This multifaceted role involves maintaining lab cleanliness, procuring consumables and reagents, managing stock inventories, and overseeing product deliveries. The candidate will execute analytical and molecular biology procedures, including ELISA, SDS-PAGE, miniprep/midiprep, and agarose gel electrophoresis, along with antibody purification and in-vitro experiments under guidance. Proficiency in MS Office, particularly Excel, meticulous record-keeping, effective communication, and the ability to meet deadlines in a fast-paced environment are essential. Flexibility for occasional late hours and a capacity to thrive in a self-directed team environment are also required, with the possibility of undertaking additional duties as needed.

The Process Engineer I/II plays a critical role in supporting manufacturing operations by delivering hands-on, solution-oriented engineering support across extrusion processes. This role contributes directly to operational efficiency, product quality, and team member experience by troubleshooting production challenges, optimizing processes, and ensuring consistent execution on the manufacturing floor. The Process Engineer partners closely with operators, technicians, and cross-functional teams to identify root causes, implement improvements, and maintain compliant, well-documented processes.

We currently have an opportunity for a Research Associate Contractor to join our Lead Discovery and Optimization group. The Lead Discovery and Optimization group is central to the assessment and selection of drug candidates and the advancement of research programs into clinical evaluation. We are looking for an enthusiastic and motivated research associate to join our Lead Discovery and Optimization team. The job requires the application of creative problem-solving approaches to the execution of new biochemical and cell-based assays. The successful candidate will have excellent practical laboratory skills coupled with aptitude and enthusiasm for automated laboratory assay techniques.

The purpose of this position is to participate in tasks related to the visual inspection of manufactured liquid injectable pharmaceutical products under cGMP regulations in Drug Product Manufacturing as well as other types of visual inspection activities, as required.

Under the supervision of the laboratory supervisor the Microbiologist I provides a high level of quality pharmaceutical microbiology testing as well as effective customer service to ARL Bio Pharma clients. This is a safety sensitive position as defined by state and federal laws that will require working with hazardous materials and/or handling medicine.

This position is within the Quality Control structure, under the Quality Organization. An Associate Scientist II, Quality Control will support the analytical testing of pharmaceutical raw materials, in-process samples, finished drug substances and drug product, and/or stability sample testing activities for new drug substances and drug products. The Associate Scientist II will also support Environmental Monitoring sample collection, support testing required for GLP Toxicology and cGMP Clinical Trial material release, as well as stability studies. The Associate Scientist II is expected to perform several analytical techniques and can make sound scientific decisions with guidance from management. This position reports to the QC-EM Scientist.

Under routine supervision, primarily responsible for the enhancement of existing products on our sustaining team. Involved in creating concepts and modeling and drafting designs utilizing 3D CAD software. Other responsibilities include drafting of design history file documents, development of test plans to assess designs, and assisting in the development processes for Manufacturing, Quality Control, Regulatory and Planning for their particular project.

The incumbent will report to the Director of Molding & Extrusion, responsible for the medical devices business. The incumbent will be responsible, at an entry level, for design, development, and commercialization of molding processes and equipment for existing products and other new medical devices. They will work with senior engineers, marketing’ and project leaders to create/redefine product specifications through innovative and robust processing solutions, as well as coordinate tool builds and validation at both internal and external sites. They will also be expected to assist in quality system compliance and regulatory filings with the FDA and other agencies outside the United States.

The Research Associate in Process Development - Upstream will develop and optimize scalable cell culture processes and contribute to transferring the process to Avid Manufacturing. In addition, the Research Associate will maintain production equipment and will research and implement new methods and technologies to enhance process operations.

The Laboratory Technician I is responsible for completing sample preparation service activities including but not limited to normalized and volumetric aliquots, DNA/RNA purification, DNA/RNA quantifications, PBMC processing, whole blood fractionation, and other client specific procedures. The Laboratory Technician is accountable for performing and documenting all activities as prescribed in the corresponding SOPs.

The Scientist II sets up Extractables & Leachables studies and conducts quantitative and qualitative analyses according to FDA, cGMP, and Boston Analytical Inc. Standard Operating Procedures. Duties include analysis of extract and pharmaceutical product samples using LC-MS, GC-MS, and/or ICP-MS. A Scientist II will also develop and validate leachables methods for these techniques.

Conduct specific chemical and physical analysis on medical devices through all stages of the manufacturing process from incoming raw materials to finished goods.

TheAssociate, Quality Systemsat Baxter, is responsible for supporting day-to-day quality system activities for the site by maintaining quality assurance processes for accuracy, conducting investigations and reports, and working cross-functionally to ensure compliance with quality standards and regulatory requirements. This role will focus on one or two of the following key areas of the quality system: Management Responsibility, Training & Document Control, Change Control, legal manufacturer activities, and regulatory compliance. In this role, the Quality Systems Associate will communicate, coordinate, and collaborate cross-functionally, and support critical initiatives and projects to meet key performance objectives. This role is essential to maintaining product integrity, supporting continuous improvement and driving compliance excellence in a fast-paced medical device facility.

Independently gather and translate user requirements into automated workflow solutions. Develop, test, implement, and optimize automated laboratory assays and workflows to improve operational efficiency, throughput, quality, and reliability. Perform verification and validation activities in accordance with regulatory and quality requirements. Configure, program, troubleshoot, and maintain automated liquid handling instrument software and associated systems. Collaborate with Information Technology (IT) and laboratory teams to support system integrations, data management, and Laboratory Information Management System (LIMS) interfaces. Provide technical support for laboratory automation systems, including troubleshooting hardware, software, workflow, and integration issues. Perform calibration, maintenance, and repair activities on laboratory automation equipment and supporting instrumentation. Participate in on-call support rotation for production automation systems. Train laboratory personnel on automated workflows, equipment operation, and best practices. Generate, maintain, and revise SOPs, work instructions, validation documentation, and other automation-related records. Track, document, and manage changes to automation methods, software configurations, and workflows. Analyze operational data and identify opportunities for process improvement and increased system reliability. Support automation projects from concept through deployment and operational handoff. Collaborate with vendors and internal stakeholders to evaluate, implement, and support automation solutions. Participate in continuous improvement initiatives and contribute technical recommendations. Perform other job-related duties as assigned. Adhere to the Code of Conduct as outlined in Baylor Genetics' Compliance Program.

The Supplier Quality Engineer I for Beckman Coulter Diagnostics is responsible for improving supplier quality for purchased components. This position reports to the Supplier Quality Manager and is part of the Supplier Quality located in Chaska, MN and will be an on-site role.

Perform incoming raw material inspections, approve material releases, and maintain purchasing specifications and process documentation. Partner closely with Production, Material Control, Engineering, and cross-functional teams to ensure supplier quality and supplier management requirements are met. Serve as a quality and regulatory resource for plant operations, project teams, and external stakeholders. Develop and maintain a strong understanding of manufacturing processes and products to investigate and resolve incoming material quality issues. Coordinate the disposition of nonconforming materials with Material Control and suppliers. Build and maintain effective supplier relationships while driving improvements in supplier quality performance. Conduct supplier audits and support supplier assessments, surveys, and evaluations. Participate in the selection, validation, qualification, and implementation of inspection equipment, tools, and technologies to ensure accurate and effective quality controls. Manage supplier quality activities for both internal BD suppliers and external suppliers. Lead and support continuous improvement initiatives using established quality and operational excellence methodologies. Monitor, maintain, and communicate supplier quality performance metrics.

The QM Associate Scientist will perform various laboratory testing, data analysis, and documentation activities to ensure product quality and compliance with regulatory standards.

BigHat Biosciences is seeking a self-motivated individual for a Research Associate I, Platform Reagents & Assay Support (PRAS), role to power our in-house reagent manufacturing and QC efforts supporting our Milliner platform.

Our Manufacturing Associates perform processing steps and manufacturing support activities in our Drug Substance facility in Research Triangle Park (RTP). These teams are the backbone of our operations – each playing a critical role in delivering our therapies to the patients who need them. Our teams are organized by the steps in the biomanufacturing process that they operate in; including – Upstream (Cell Culture), Downstream (Purification), and Media & Solution Preparation. Manufacturing Associates perform these critical steps in a clean environment governed by Current Good Manufacturing Practices (cGMP).

As a member of our Clinic Trials Study Management (CTSM) team, the Research Associate works with clinical trial site and client contacts to fully document and resolve data reconciliation queries pertaining to patient visit results. Ensures patient reports are provided to study contacts in a timely manner by monitoring ACM’s internal Clinical Trials Management System and addressing any data queries that may delay a report from being issued.

Adams Clinical is a rapidly growing research site network specializing focused on late phase industry-sponsored trials of novel treatments for a variety of psychiatric and neurological conditions, supporting both inpatient and outpatient studies. Adams Clinical Site Network has locations in Watertown, MA; Boston, MA; Harlem, NY; Bronx, NY; Philadelphia, PA; and Dallas, TX. We are seeking entry-level applicants for the Clinical Research Assistant role at our Dallas location. This role is ideal for entry-level candidates interested in learning clinical research operations, contributing to study execution, and developing foundational skills in patient interaction, data management, and regulatory compliance. The Clinical Research Assistant (RA) provides foundational support in the conduct of clinical trials at the site level. Working under the direct supervision of a CRC II, CRC III, or Site Manager, the RA assists with operational, administrative, and participant-facing tasks to ensure studies run smoothly and in accordance with ICH-GCP, regulatory requirements, and protocol guidelines. This role is an ideal entry point for individuals seeking to gain hands-on experience in clinical research.

The Associate I, Lab Support, performs cGMP laboratory support activities including Sample Accessioning, Product Reserve management, Temperature Monitoring of storage chambers, Glassware Cleaning, Supply Inventory management, etc. This role may also assist with Stability Studies and other QC initiatives, performs all work under GMP conditions., and provides customer support to QC analysts.

The Technician I, Microbiology, Quality Control, performs environmental monitoring and water sampling within controlled manufacturing areas and QC laboratory.

The Associate Test Design Engineer will generally assist with providing design, engineering, testing and analysis support to other engineers and designers inthe development and maintenance of orthopedic implants and instruments.

As a Field Service Engineer for Agilent, you will work at a variety of labs, so having an appetite for continuously learning about new instruments, software and consumables is key. Applying your communication skills, creativity and can-do attitude is essential. The ability to help with solving customer problems and a commitment to deliver the highest levels of customer service is how you will build customer success. This position will be focused primarily on GC and GCMS products. Prior experience preferred.

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek ---- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com. We are seeking an R&D Scientist to join our team and support the development, testing, and improvement of genomic, life science, and diagnostic products.

The Associate Process Engineer (Drug Product) is an entry level technical contributor within Manufacturing Science and Technology (MS&T), responsible for supporting implementation and sustainment of biopharmaceutical equipment and processes supporting gene therapy manufacturing. This role supports equipment and process introduction, technical transfer activities, engineering studies, and troubleshooting under the guidance of senior engineering staff to ensure systems are fit- for-purpose and ready for operations. This is a highly collaborative role that works closely with cross-functional teams including Process Development, Manufacturing, MSAT Operations, Validation, Quality, and external partners to ensure processes are scalable, robust, and aligned with global regulatory expectations.

We are seeking an Associate Scientist - I to join our Content Development team with a passion for innovation and someone who can help in developing immunoassays for new biomarker detection and help augment our quantitation capability. You will be working in a fast-paced environment on multiple projects and will be a part of a rapidly growing company to make a big impact in life science research and early disease diagnosis.

The Quality Specialist will provide site quality support in a fast-paced environment by effectively performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements and is proficient in all document and protocol approvals applicable to the respective processes executed at the respective lab or manufacturing facility. Activities include reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed. The position develops SOPs or other quality documents as needed.

The Quality Control Data Review Specialist is an effective member of the Laboratory Operations team. Position is accountable for driving results in a fast-paced environment by effectively performing various activities at range of complexity to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting basic floor audits and process inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance-oriented training as necessary. The QC Data Review Specialist assists with the development of SOPs or other quality documents as needed. Business needs and deadlines will require the employee to perform work duties outside of standard work hours on occasion.

The Next Wave Biology group is seeking a motivated candidate to fill an Associate Scientist II position to join our dynamic, fast-paced and interdisciplinary team. This position is an opportunity to potentially see one’s work progress from the bench to the clinic and positively impact patients’ lives. The successful candidate will support development of current therapeutic programs and will also be involved in the discovery of RNAi compounds for a variety of novel indications, supporting the preclinical efforts foundational to their transition into the clinic. The successful candidate will have background in biological sciences and be technically skilled in basic laboratory techniques. Responsibilities will include designing and executing studies evaluating small interfering RNAs (siRNAs) in rodent models in vivo and in cellular models in vitro and conducting downstream molecular and biochemical-based assays, including transcript and protein quantitation. A passion for science, a desire to learn new techniques and a team-oriented mindset are a must. Experience and willingness to work with rodents and perform cell culture are also essential. This position is onsite and will be primarily located in Cambridge, MA.

NSF is seeking a Materials Engineer who with direction, is responsible for the review and interpretation of standards and protocols, development of test methods, design of test equipment, and analysis of test data. Work with Engineering technicians in the build and operation of test equipment and conduct of testing.

NSF is seeking a Project manager. As a Project Manager, you will lead the planning, coordination, and execution of projects, ensuring they are delivered on time and within scope. You will serve as the central point of accountability for project performance, collaborating with internal teams and stakeholders to drive successful outcomes and revenue delivery. This role requires a proactive, detail-oriented professional with strong organizational and communication skills, and a passion for operational excellence.

Let’s do this. Let’s change the world. In this vital role you will be responsible for developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative potency and biological characterization assays and supporting sample testing and regulatory submissions.Implementing state-of-the-art and fit-for-purpose analytical potency methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations. Assisting in the preparation of technical reports for investigations, product and impurity characterization, and regulatory submissions. Generating and analyzing analytical data to support: product development and regulatory submissions. May contribute to critical analytical development teams (e.g., product and process development teams, product quality teams) by providing analytical updates, analytical documentation and data interpretation. Keeps current in analytical development field including literature and technology development. Supports analytical projects involving method development, qualification, and transfer.

Let’s do this. Let’s change the world. In this vital role you will be a part of a fast-paced, integrated, and interactive research group exploring therapeutics for immuno-oncology programs. You will be responsible for generating and communicating pharmacology data to support the progression of oncology and immunotherapy research programs.

Let’s do this! Let’s change the world! The Sr. Associate Quality Assurance position supports Amgen’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and quality oversight of our Drug Product Manufacturing facility, ensuring the execution of our processes, procedures, and use of quality systems aligns with regulatory requirements.

The EH&S Specialist supports safety and environmental compliance for multiple Kentucky warehouses and distribution sites by implementing EHS programs and ensuring adherence to federal, state, and local regulations, including Kentucky Occupational Safety and Health (KOSH) requirements. The role collaborates with site leadership and the corporate EHS team to conduct inspections, identify hazards, support incident investigations, coordinate training, and maintain accurate safety and environmental records. Additionally, the specialist assists with regulatory reporting and helps prepare sites for audits and inspections.

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 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.

Vaxcyte is seeking an energetic and talented individual to join the Drug Product (DP) Process Development team within the broader Process Development organization. The primary responsibility of the incumbent will be to provide technical and engineering support across DP process development activities, spanning late-stage clinical supply, process characterization, tech transfer, and commercial readiness (PPQ) of Vaxcyte’s lead programs. The role requires close collaboration with internal cross-functional partners (Formulation, Analytical Development, MSAT, Quality) as well as external contract development and manufacturing organizations (CDMOs) supporting Vaxcyte’s fill/finish operations.

Vaxcyte is looking for an Associate Scientist I (Contract) who will contribute to the research and development of a novel bacterial polysaccharide conjugate vaccine. Specifically, this will include upstream bacterial culture, downstream polysaccharide purification and processing, and analytical characterization of polysaccharides and polysaccharide-protein conjugates. The ideal candidate will have an excellent understanding of bioreactors, Biosafety Level 2 (BSL-2) aseptic cell culture, column chromatography, tangential flow filtration, related analytical chemistry principles, and significant laboratory experience. The successful candidate will be expected to independently execute laboratory experiments following established protocols and standard operating procedures. The candidate will also contribute when needed to a range of related areas, such as analytical development and stability studies. Responsibilities will also include record management, presenting data at group meetings, and contributing to the authorship of laboratory protocols and development reports.

We are seeking a highly skilled and motivated Associate Scientist II (Contract) to join our Analytical Development team to support the characterization of drug substances, protein intermediates, and drug products using LC-MS and complementary analytical techniques The ideal candidate would be central to implementing mass spectrometry-based workflows, interpreting complex data, and collaborating cross-functionally to advance our vaccine programs.

Vaxcyte is looking for an energetic and talented individual to join our Drug Product Development team. The candidate must have knowledge of and practical experience in analyzing and characterizing biomolecules (proteins, polysaccharide conjugates, vaccines) using a variety of methods, including immunoassays, chromatography, spectrophotometric techniques, light scattering, and particle sizing. Experience in analyzing vaccine and adjuvant-containing formulations is a plus. In addition, Vaxcyte is looking for an experienced and flexible individual who would be comfortable working on multiple projects at once, with fluid prioritization to enable aggressive timelines. This position is for a lab-based scientific role and requires excellent scientific judgement, independence, rigor, and thorough record-keeping.

The primary function of a QC Laboratory Technician is to perform the following duties: Sample receipt (logging and labeling) of all samples into the lab, verifying documentation, DEA forms, etc., and entering into Excel to aid laboratory scheduling by supervision. Ordering reagents/standards/office supplies and submitting to purchasing. Glassware cleaning. Solution/standard preparation. DEA reconciliation of completed samples. Receiving reagents/consumables. Inventory management (full inventory of reagents in the lab each week). Receiving and tracking reference standards. General house-keeping such as stocking consumables. Destruction of completed noncontrolled samples. Assist with Stability Program management (sample placement/retrieval from the chambers). Assist with retaining sample storage/retrieval.

The primary purpose of the Manufacturing Engineer position is to apply engineering principles to drive process improvements in the manufacturing of medical devices while positively affecting quality, delivery, cost, safety, and morale. This role requires a positive attitude, strong attention to detail, and a desire for professional growth with high internal expectations.

Coordinate and perform the release of finished goods materials in SAP. Coordinate the movement of product into and out of quality hold status and perform any associated transactions in SAP. Accurately maintain and update batch files. Review, analyze, and approve temperature data for temperature monitored shipments. Assist with coordination of product launches. Assist with product donation orders. Assist in updating and writing Standard Operating Procedures (SOPs). Initiate, review, approve and close TrackWise events including PMSIs, Incidents, Investigations and Notices of Rejections.

The Operations Processing Technician I support the processing and documentation requirements of tissue during the cleaning, cutting, shaping, inspecting, and packaging operations for transplantation purposes. The Operations Processing Technician I is also responsible for ensuring that all equipment and supplies used for processing are maintained and ready for use, and that all Processing Room maintenance is completed daily while complying with Quality Assurance requirements as mandated by federal, state, and trade regulations.

Vyriad is a clinical stage biotechnology company based in Rochester MN. We are developing the next generation of targeted genetic medicines for cancer therapy. The Bioproduction Technologist will be responsible for upstream and/or downstream process development and GMP manufacturing of oncolytic viruses, lentiviral vectors and other biologics for clinical trials. The Bioproduction Technologist plays a vital role in the day-to-day process development projects and manufacturing operations in compliance with cGMP standards. Virus and gene therapy manufacturing operations involve aseptic processing in a pharmaceutical cleanroom facility, large-scale cell culture in shake flasks and bioreactors, vector generation, purification, concentration, and fill and finish operations, according to established standard operating procedures (SOPs). In addition, staff are responsible for the daily operations and environmental monitoring of the GMP facility to ensure compliance with applicable regulations.

Wave Life Sciences is seeking a highly motivated Research Associate or Associate Scientist in Oligo Chemistry and Biochemistry Research to join its team in Cambridge, Massachusetts. This is an ideal opportunity for an individual who is interested in learning cutting edge technologies and who thrives in a team-oriented, fast-paced, cross-disciplinary biotech environment. The candidate will take an active role in LC/MS based bioanalytical chemistry, oligonucleotide stability assay, and oligonucleotide metabolite identification for discovery and preclinical activities.

The Project Specialist supports cross-functional engagements by coordinating project activities, maintaining documentation, and ensuring timelines, deliverables, and client expectations are met. This role works closely with Project and Program Managers to ensure logistical clarity, timely deliverables, and effective communication across internal teams and external partners, and is ideal for someone who is detail-oriented, comfortable working in regulated environments, and energized by supporting multiple projects simultaneously.

Ready to build your career in orthopedic innovation? Paragon 28—a Zimmer Biomet company specializing in foot and ankle solutions—is looking for a Quality Engineer I – Compliance to join our team in Englewood, Colorado. In this impactful role, you’ll help uphold and strengthen our Quality Management System, with a focus on Corrective and Preventive Actions (CAPA) and Supplier CAPA processes. You’ll play a key part in ensuring product quality and regulatory compliance by investigating medical device complaints, supporting product evaluations, and analyzing system performance. This is an excellent opportunity for someone who thrives on problem-solving, values precision, and wants to contribute to the continuous improvement of life-changing medical technologies. This is an onsite position with some remote work flexibility.

This position is responsible for performing a sterility assurance function with its primary purpose to develop, validate and monitor product sterilization processes in accordance with industry standards. This is accomplished through a wide variety of duties which support new product development, manufacturing operations, implant/instrument sterilization, and special projects in the Environmental/Microbiology Services Laboratories.

Responsible for supporting international product registrations from headquarters, including processing of regulatory documentation, notarization and legalization of documents, and tracking and reporting on the status of global registrations. Reviews and processes export invoices and Regulatory Affairs’ related invoices, coordinates the ordering of product samples, issues Certificates to Foreign Government (CFGs), and maintains control of electronic Instructions for Use (eIFUs). Provides general administrative and coordination support to the Regulatory Affairs department.

This position works out of our Sturgis, MI 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. For over 70 years, Abbott’s Sturgis, Mich., has been impacting its community while producing products that provide essential nutrition to millions of families around the world. Working here, you’ll feel part of a family that is dedicated to making a difference and helping others.

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. Our location in Columbus, OH, currently has an opportunity for an Associate Product Development Scientist. In Research & Development (R&D) our ambition is to provide innovative high-quality products, creating sustainable value, delivering superior user experience and enhancing health outcomes at all stages of life.

Performs functions associated with cGMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components and final materials. Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment. Determines and may assist in developing methods and procedures to control or modify the manufacturing process.

Performs functions associated with cGMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components and final materials. Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment. Determines and may assist in developing methods and procedures to control or modify the manufacturing process.

Performs functions associated with cGMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components and final materials. Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment. Determines and may assist in developing methods and procedures to control or modify the manufacturing process.

Responsible for basic configuration and programming per AbbVie’s change management procedures for the manufacturing process, utilities and facilities control systems. This position performs system troubleshooting during and outside business hours as necessary. Responsible for the maintenance of assigned site operations technologies (OT) systems per applicable departmental procedures.

The Research Associate/Senior Research Associate, Real World Evidence (RWE) is part of the global Real World & Late Phase (RWLP) Business Unit, supporting the generation of real-world evidence, and patient outcomes evidence across the drug development lifecycle. In this role, you will contribute to and or lead real-world research initiatives that inform clinical strategy, regulatory engagement, and market access decisions for life sciences clients. Working closely with senior team members, you will support the design and execution of retrospective and prospective studies while developing your expertise in RWE and outcomes research methodologies. This position is well suited to professionals seeking meaningful exposure to or to deepen their expertise in evidence generation within a collaborative, well-supported team environment that values high-quality work and sustainable performance.

Supports engineering activities such as design and execution of system level testing. Includes development of protocols, test methods, and test equipment required to verify system performance.

The basic purpose is to conduct technical activities according to protocols. Receives daily tasking assignments, under moderate supervision. Functions as a member of work team by assisting others and promoting a team-oriented work environment. Performs all work in conformance with applicable regulations. Performs all work in a safe manner. Works within the laboratory or processing environment.

Teleflex is seeking a Document Control Specialist to join our Quality department. The successful candidate will be responsible for reviewing batch records, work orders, and overall data generated for Blood Products. Strong attention to detail and understanding of GMP regulations are necessary for this position.

Support Lead Auditor with audit functions. Participate in conducting internal audits under the direction of the Lead Auditor. Assist with completion of partnership pre-audit questionnaires. Oversee drafting of internal and external audit responses to closure. Administrative audit functions as needed. Lead partnership/client audits. Communicate with partners as needed. Assist with client pre-qualification questionnaires regarding quality assurance (QA) and the quality management system (QMS). Communication with Tempus’ Notified Body as needed. Comply with documented Quality Management System procedures. Completion of assigned training on time. Review QMS documentation against applicable regulations for international compliance Remain up to date with applicable regulations to communicate changing requirements to Management. Track corrective and preventive actions (CAPAs), deviations, and follow-up activities related to audit outcomes. Assist with inspection readiness efforts and external audits. Help identify opportunities for process improvement related compliance and inspection readiness. Managing and hosting external audits including regulatory inspections and CAP/CLIA Inspections. Collaborate with cross-functional teams to collect documentation and support compliance activities. Perform other duties and projects as assigned and ability to be flexible in supporting various quality system areas.

Work in a cutting-edge clinical laboratory to provide high-quality molecular test data with rapid turnaround times. Perform complex molecular-based procedures with a high degree of quality and in accordance with established protocols. Able to identify deviations from established SOPS and apply routine fixes for known and common issues with standard solutions. Able to provide input when troubleshooting and implement solutions under direction and authorization. Perform molecular techniques, which might include quantitative PCR, next-generation sequencing, nucleic acid extraction, DNA/RNA quantification and qualification or genotyping. Perform quality control, calibration, maintenance and proficiency testing in accordance with current laboratory procedures. Sterilizing laboratory equipment and workspaces as assigned. Entering clinical patient data into the Laboratory Information Management system. 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 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 nucleic acid extraction and DNA/RNA quantification and qualification using robotics and automated liquid handlers. 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.

As an Automation Specialist I you will perform a variety of routine to moderately complex activities in support of automated instrumentation. You will conduct activities following company SOPs and policies, while also adhering to automation best practices with periodic direct supervision.

Join our collaborative team at Thermo Fisher Scientific as a Project Manager I, where you'll lead initiatives that help make the world healthier, cleaner, and safer. In this role, you'll manage cross-functional projects while ensuring excellent customer service and operational efficiency. You'll coordinate with internal teams and external stakeholders to deliver projects on time and within scope, from clinical trials and pharmaceutical services to technical documentation and quality management. This position offers an opportunity to develop your project management skills while contributing to meaningful scientific advances and healthcare solutions.

As part of the Thermo Fisher Scientific team, you’ll do meaningful work that makes a positive impact on a global scale. Join colleagues who bring our Mission to life every day—enabling customers to make the world healthier, cleaner, and safer. Join our growing validation team supporting Automatic Visual Inspection (AVI) operations, a critical and expanding function within sterile pharmaceutical manufacturing. With new lines being added—including auto-injector technology—this role offers hands-on experience in one of the most in-demand areas of the industry. This is an entry-level opportunity designed for growth, where you’ll gain valuable, highly marketable experience in sterile manufacturing validation.

As an Industrial Design Engineer II, you will be engineering products and supporting manufacturing operations with the goal of growing efficiency, quality, and productivity. In this role, you will work with the business in optimizing current processes and manufacturing operations to improve manufacturability of product for quality, ergonomic, and efficiency improvements.

In this role, the Associate Scientist I/II will provide hands-on formulation and process expertise during the development of clinical and commercial formulations for orally inhaled and nasal drug products (OINDPs). Conducts laboratory activities including formulation and manufacturing process development, manufacturing process scale-up and process transfer activities across equipment, manufacturing scales and sites. The individual will design and execute formulation experiments, organize and analyze results with minimal supervision, and communicate data and interpretation to product development team. Contribute towards the development of orally inhaled and nasal drug products (OINDPs) by following regulatory guidelines, industry best practices, US FDA cGMPs, and other relevant guidelines.

Maravai LifeSciences is seeking a #MiracleMaker to join our manufacturing team as a Manufacturing Associate I, RNA Reagents. As a Manufacturing Associate I, RNA Reagents, you will produce research grade components and products by setting-up, cleaning, operating, and maintaining equipment; performing enzymatic reactions; utilizing purification systems, authoring and implementing SOPs, and documenting action in batch records.

We are seeking an outstanding, innovative, and creative candidate to join Twist Biopharma as a Research Associate in Antibody Discovery and Engineering. As part of Biopharma, you will play multiple roles within a team responsible for antibody discovery and engineering utilizing in vitro display technologies, e.g. phage display, ribosome display, and yeast display. The ideal candidate will have relevant experience including molecular biology skills related to the design, creation, and sequence verification of DNA plasmids, and familiarity with antibody fragment library design and construction is a plus. Repertoire analysis using both NGS and Sanger sequencing is desirable. You will learn and develop essential skills of the antibody engineering workflow in a fast paced innovative team environment.

Varda Space Industries is seeking a motivated Laboratory Technician to provide critical laboratory support for our Analytical Sciences team. This role will focus on preparation of stock solutions, sample preparation, maintenance of laboratory equipment and chemical inventory, and execution of analytical testing to support analytical method development activities. The ideal candidate will have hands-on experience in pharmaceutical laboratory operations and familiarity with drug product characterization techniques. This is a 6 month temp position and it can potentially lead to a full-time Research Associate position depending on performance and business needs.

Varda Space Industries is seeking a motivated Research Associate to provide critical laboratory support for our Biologics Formulation team. This role will focus on preparation of stock solutions, maintenance of laboratory equipment, and execution of analytical testing to support ongoing protein formulation development activities. The ideal candidate will have hands-on experience in biopharmaceutical laboratory operations and familiarity with protein characterization techniques.

As the Propulsion Engineer II - Ground Fluids, you will serve as the technical authority for ground fluid systems across all Varda spacecraft programs. You will own the full lifecycle — from system architecture and schematic development through build, test, and live flight operations — and define the processes, standards, and infrastructure that every mission depends on. As we scale our launch cadence, you will shape our operational approach, lead propellant loading campaigns across multiple sites, and be the technical escalation point when things get hard. This role is open at the Engineer II level, with levels determined based on candidate experience.

Varda is looking for a motivated Structures Engineer to join our team. In this role, you'll support the design, analysis, testing, and integration of structural components for our spaceflight systems and reentry vehicles. This is a great opportunity to grow your engineering skills while working alongside experienced engineers on real hardware in a fast-paced environment. You’ll contribute to projects that range from spacecraft structures to mechanical ground support equipment, while learning how to apply engineering fundamentals to solve complex, real-world problems.

Strand is looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team. This opportunity will offer the employee the ability to work in a matrix-based environment and be a part of the future strategy of the company. We are looking for a highly motivated and innovative candidate for the role of Associate Scientist I of Nanoparticle Process Development. This individual will support in production and scale up of LNPs with nucleic acid payload. Reporting to the Principal Scientist of Nanoparticle Process Development, the right candidate will be a strategic thinker that brings a leadership presence and enthusiasm for Strand along with a deep scientific knowledge.

The primary responsibility of this role is to provide technician support within the Reagents work center and provide updates on ongoing builds. The successful candidate must demonstrate the ability to understand formulation processes, work with manufacturing processes and equipment, maintain detailed written documentation, and work effectively with others in a team environment.

Regeneron's Preclinical Manufacturing & Process Development Group (PMPD), located in Tarrytown, NY, is seeking a Process Development Engineer as a full-time position to work in the Purification Development group. In this role, you will be responsible for purification process development and support purification of various pre-clinical biological molecules to provide reagents for Regeneron’s research and discovery groups and assist in technology transfers to internal manufacturing sites.

Regeneron Pharmaceutical's Analytical and Biological Mass Spectrometry Group (ABMS), located in Tarrytown, NY is seeking a motivated Associate Scientist to join our fast-paced and interdisciplinary team working on analytical and bioanalytical development on novel siRNA/oligonucleotide-based modalities in a diverse genetic medicine pipeline.

We are seeking a Process Development Engineer I to join our Synthetic and Bioconjugation Scale-up Technologies (SBST) group as a part of our Preclinical Manufacturing & Process Development (PMPD) department. In this exciting new role, you will develop manufacturing processes for the production of synthetic small-molecules used in Regeneron’s diverse range of therapeutic modalities. You would work in close collaboration with cross-functional teams performing chemical process development and optimization using the principles of Quality by Design (QbD) to deliver processes suitable for GMP production. This role also involves process scale-up and technology transfer of manufacturing related workflows to Contract Development and Manufacturing Organizations (CDMOs) to ensure timely and reliable entrance to the clinic and eventual commercialization.

The Immunology and Inflammation group is seeking an Associate Scientist to support the development of therapeutics for autoimmune disease. This role involves joining a highly collaborative team working in autoimmunity, immune cell biology, and tissue immunity. You will have the opportunity to engage in cutting edge immunological research as part of our discovery efforts and to contribute to human health.

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.

The Biochemist I will be an integral member of a team that manufactures and provides purified antibodies to enable studies for novel applications in precision medicine, oncology, immunology, neuroscience, and stem cell research. This position will report to a team leader and will ensure the highest quality of our finalized antibody products. This is a great opportunity to work in a fast-paced and dynamic environment for you to enhance your knowledge in the biotechnology industry! In this position you will perform antibody purification via column chromatography both manually and automatically, troubleshoot problematic errors, continue to improve methodologies for efficiency, follow Standard Operating Procedures (SOP)s, and cross train on a variety of other supporting tasks.

BioLegend has an exciting new opportunity in our Custom Solutions team for a life science graduate with 1-3years’ experiencein the biotech or pharma industry. The Custom Project Coordinator willhelpcoordinate product manufacturingplanandcontribute toBioLegend’s mission of providing legendary customer service. This role offers broad cross-functional exposure across the business, serving as a primary point of contact for key customer accounts — including VIP clients and biopharma partners. High performers will find meaningful opportunities for career growth, with pathways tailored to individual strengths and areas of specialization.Thesuccessful individual will demonstrate high attention to detail, strong problem-solving skills, and ability to stay on top of multiple projects using project and customer management software.

EUROIMMUN US Quality Control Department aims to be a full-service Quality Control and reference laboratory offering product testing to ensure they meet predetermined quality standards, complaint testing, and customer support. The Laboratory Technologist will be a valuable addition to the Quality Control laboratory. Under the guidance of the laboratory manager, the Laboratory Technologist will be responsible for ensuring the highest standards of product quality through comprehensive testing and analysis in our state-of-the-art laboratory facilities. The Laboratory Technologist will report to the Quality Control Manager.

BioLegend is looking for a Research Associate to join the Exploratory R&D team. The Research Associate will be involved in new cell culture reagent product development and supporting existing products. General responsibilities include determining the feasibility and launching of new products through establishing/executing optimized cell culture models, collaborating with manufacturing/quality control teams for tech. transfers, and troubleshooting issues associated with existing products. This role requires mammalian cell culture experience while knowledge of process development for reagents such as small- & large-scale antibody production is a plus. Candidates must have excellent organizational skills, attention to detail, and accuracy while being able to maintain good documentation practices and generate reports. In addition, this role requires proficiency in computer software use (Excel, Word, and PowerPoint).

BioLegend is seeking a motivated individual to support immunoassay product development and manufacturing within the Biomarker Immunoassay Group. The Research Associate will participate in multiple aspects of the product development process, including experimental design, assay initiation and testing, troubleshooting, manufacturing support, technology transfer, and product launch activities. More specifically, the individual will work closely with experienced scientists to manage customer-facing documentation, support the initial production of new panel lots, facilitate technology transfer and process improvements, respond to customer product inquiries, and assist with pilot studies and special product releases. These immunoassay products enable the simultaneous detection of up to 18 important biomarkers associated with inflammatory diseases, stem cells, cancer, cardiovascular disease, and neurodegenerative diseases, providing valuable tools for the biomedical research community. This position offers an excellent opportunity to gain hands-on experience in a fast-paced biotechnology industry environment. The individual will be expected to manage assigned functions and tasks with strong communication skills and increasing independence after appropriate training.

As a member of the product development team, among the Associate Scientist I’s main responsibilities are the execution of experimental protocols and collection of data. The Associate Scientist I is expected to actively participate in protocol development and design, as well as data interpretation. Areas of research and development may include any of Sakura’s anatomic pathology product lines. As such, the successful candidate is expected to learn the function and operation of all Sakura instrument systems, tissue fixation, processing, embedding, sectioning and staining. The candidate must be able to collate data and write up results in a clear and concise manner. The technical experience required for this position includes some of the following areas: microtomy, immunohistochemistry, immunofluorescence, in situ hybridization, immunoassays, formulation of reagents, spectrophotometric analysis, experimental design with proper selection and implementation of controls, replicates, and acceptance criteria, and general laboratory testing or quality evaluation activities.

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

The Laboratory Analyst is responsible for performing complex analytical testing on cannabis and cannabis-derived products using advanced instrumentation such as HPLC, GC-MS, ICP-MS, and microbial testing platforms. This role requires a high level of technical expertise, strict adherence to SOPs, and compliance with all state regulations and ISO/IEC 17025 standards. Laboratory Analysts ensure the accuracy and reliability of test results, maintain detailed records, and contribute to the overall quality and efficiency of laboratory operations.

The primary function of a QC Chemist I is to perform qualitative and quantitative chemical and physical analyses at a high level in support of one of the following areas: Analysis of raw materials and packaging components. Analysis of in-process and finished drug products, including stability testing, for primarily high-volume products

Starkey is hiring a Mechanical Engineer II - Continuation Engineering at its global headquarters in Eden Prairie, MN. This position under general supervision, the team member is responsible for executing mechanical engineering changes to released hearing aid products and production tooling within the CE organization. The Mechanical Engineer II – CE drives quality improvements, cost reductions, supply chain continuity, and manufacturing scalability initiatives by designing and validating updated mechanical components, assembly tooling, and fixtures. Has close collaboration with CE Electrical, Systems Verification, Quality, Supply Chain, R&D, and Manufacturing teams to ensure all changes maintain prod

The Quality Engineer I in our Eden Prairie, MN location 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.

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Validation Technicians in the Applied Sterilization Technologies (AST) Brooklyn Park, Minnesota location are responsible for Customer process validation execution. They work closely with the TechTeam and/or the Customer to assure the protocols are executed with care and are documented properly. Generates accurate records evidencing completion of these activities and maintains laboratory spaces and supplies.

Strand is looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team. This opportunity will offer the employee the ability to work in a matrix-based environment and be a part of the future strategy of the company. We are looking for a highly motivated and innovative candidate for the role of Associate Scientist I/II of Analytical Operations. This individual will support in day-to-day analytical operations as an analyst. Reporting initially to the Principal Associate Scientist of Analytical Development, the right candidate will be a strategic thinker that brings a leadership presence and enthusiasm for Strand along with a deep scientific knowledge.

Strand is looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team. This opportunity will offer the employee the ability to work in a matrix-based environment and be a part of the future strategy of the company. We are looking for a highly motivated and innovative candidate for the role of Associate Scientist I of Nanoparticle Process Development. This individual will support in production and scale up of LNPs with nucleic acid payload. Reporting to the Principal Scientist of Nanoparticle Process Development, the right candidate will be a strategic thinker that brings a leadership presence and enthusiasm for Strand along with a deep scientific knowledge.

Stryker is seeking a Design Engineer for our Customized Implants division in Ventura, California. Here, we specialize in designing custom temporomandibular joint (TMJ) implants that restore jaw function and transform lives. As a Design Engineer, you will gain hands-on experience in a collaborative environment, working closely with experienced designers and clinical specialists to create patient-specific solutions.