Links to 643 Entry-Level Biotechnology & Life Science Jobs

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

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

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

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

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

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

The Quality Engineer is expected to assist in the identification and resolution of quality related issues. You'll have the opportunity to apply subject matter expertise, in an individual contributor role with limited supervision. Expected to provide quality engineering support to the site to ensure manufacturing/quality requirements are met and understand and elevate issues related to quality validations. Work with a team to establish and implement a dynamic structure that fosters and ensures consistent compliance to external laws, regulations, guidances and standards that affect the quality system. The team will develop and follow a process to implement a structure that will facilitate a consistent implementation of external quality system standards including leading activities for site inspection readiness. This structure will improve coordination between functions and increase the awareness and compliance of external requirements.

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

The Oncology Discovery Research team is seeking a highly motivated and experienced Associate Scientist II with expertise in CRISPR genome editing within the Oncology Assay Lab located in Lake County, IL. This is an excellent opportunity for a cell biologist/molecular biologist to make significant contributions to the advancement of oncology drug discovery programs within a dynamic and collaborative environment. The selected individual will play a crucial role in generating high-quality drug development candidates targeting promising therapeutic areas in oncology. An important responsibility will be to investigate, identify, develop, and optimize new methods and techniques. This role will be part of a team of supporting multiple Oncology Discovery programs and projects.

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

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

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

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

The Analytical Scientist I or II will support the development and validation of analytical methods for raw materials, work-in-process, and finished products to provide testing support for the formulation development and clinical supplies release process. The Scientist II will also be expected to provide some training, coaching, and mentoring for more junior scientists.

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

Preparing solutions and reagents for performing assays on the bench. Perform Next Generation Sequencing-based genomic assays on different workflows (few listed below): o RNAseq. Whole Genome Sequencing. Whole Exome Sequencing. Carry out genomic assays under Biosafety Level II Policies and in regulatory compliance. Perform Operational Qualification and Performance Qualification on Next Generation Sequencers. Strictly follow standard operating procedures set forth for processing biological specimens while complying with laboratory safety protocols. Strict recordkeeping of all laboratory procedures. Continue acquiring next generation sequencing knowledge to support molecular biology techniques. Collaborate within the group and cross departmental to achieve goals.

Affinia Therapeutics is seeking an experienced Research Associate (job level will commensurate with experience) to join our Preclinical Analytics laboratory team. You will be part of a group dedicated to the advancing of gene therapies based on vectors derived from our unique AAV platform. You will actively contribute to the development and execution of analytical assays supporting studies conducted by the translational science team at Affinia. You will work to establish methods and analyze samples to meet timelines for our internal development programs. You will contribute to the evaluation of new analytical technologies, the development of more efficient laboratory workflows as well as maintaining a culture of quality and excellence.

We have an opportunity for an MSAT Engineer I/II to join the Manufacturing Science and Technology (MSAT) team at AGC Biologics in Boulder, CO. This position requires technical problem-solving and inter-departmental collaboration. Responsibilities will be varied, requiring time management skills and ability to deliver against fluid timelines. This role is responsible for 24/7 production support when manufacturing operations are in progress including direct Person in Plant and customer support. Other responsibilities include technology transfer support, new proposal support, quality systems support and data collection, trending, and analysis support.

As the Night Shift GMP Cleaning and Sanitization Technician, you will be responsible for maintaining the cleanliness and compliance of GMP regulated areas and ensuring facilities are properly restocked. You will also be expected to follow and document all sanitization processes in line with our SOPs and regulatory requirements.

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

We are looking for a talented and dedicated Research Associate to join the CDx Group in our R&D Department. You will provide technical support to develop accurate, robust and precise assays. Your challenge will be to create value for Agilent through innovative ideas that either create new businesses or enhance existing ones.

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

Join our Next Generation Sequencing (NGS) Probe manufacturing team as a Manufacturing Scientist at Agilent Technologies. At Agilent Technologies, we are dedicated to advancing scientific discoveries that improve the quality of life. Our Manufacturing group is a collaborative and diverse team made up of members who learn quickly on the job and anticipate/resolve potential manufacturing issues while maintaining the highest level of quality. This is essential in delivering innovative, high-quality products to our customers worldwide.

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

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

Akston is looking for a highly motivated and energetic Research Associate I/II to join our dynamic and diverse R&D team. In this role, you'll play a key part in supporting our efforts to develop innovative biologic therapies. The ideal candidate will collaborate closely with cross-functional teams, translating strategic goals into actionable plans. Experience with biological entities (e.g., fusion proteins and monoclonal antibodies) is essential. A background in analytical chemistry, biochemistry, biotechnology, chemical biology, chemical engineering, molecular biology or related fields is highly desirable.

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

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

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

Conduct Quality Control testing of materials and production samples as required to support contact lens production, performing assigned tasks according to approved SOP’s, methods, and procedures with adherence to cGMP, FDA, and Corporate Quality policies and regulations. Perform routine and non-routine incoming inspection procedures in generating information for the release of materials for production use, as well as to communicate the disposition of materials to internal and external customers (with minimal supervisory or designee direction). This position also assists in the solution of technical problems, with defined scope.

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

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

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

The Neurophysiology Group within the Research and Development organization is searching for an experienced electrophysiologist to support novel drug discovery research in CNS disorders. This position will be part of a larger multidisciplinary team challenged with interrogating the pharmacological properties and synaptic mechanism(s) of action of compounds in a variety of neuronal systems. Individuals with exceptional neurophysiology experience are encouraged to apply. The ideal candidate will have neuroscience research experience employing a variety of in vitro/in vivo electrophysiology techniques including traditional whole-cell patch-clamp, extracellular field potential recordings, and qEEG. Additional computational or programming experience is also required. Highest priority will be given to candidates with a strong desire to be in the laboratory designing and conducting experiments to support discovery projects.

Responsible for managing Research Associates and assisting Scientists on studies/projects. Assists with training other laboratory staff in technical procedures. Assist with evaluating and optimizing the utilization of laboratory resources to attain operational goals, meet study deadlines, and deliver quality results. Works with Laboratory Sciences Senior Manager of Operations in formulating current and long-range plans, objectives and policies.

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

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

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

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.

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

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

The QC Microbiologist I, Environmental Monitoring will learn, understand, and perform routine entry level sampling of cleanrooms and utilities according to written procedures under cGMP conditions; as well as tasks involved with clerical and logistical laboratory tasks.

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

Join a company where you can make a difference from day one and help make the world a better and safer place. ARL Bio Pharma provides analytical and microbiological testing for the pharmaceutical industry. Our laboratory works with pharmaceutical companies, compounding and hospital pharmacies, drug manufacturers, and raw material suppliers bringing excellence to pharmaceutical sciences and making pharmaceuticals safer. This position is a fantastic stepping-stone for those with some basic experience looking to expand their career in the interesting world of the pharmaceutical industry. The Chemist I is responsible for utilizing established methods and standard lab equipment/instrumentation (HPLC, IC) to qualitatively and quantitatively analyze routine pharmaceutical substances and formulations.

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.

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

Manages with autonomy and independent judgement the daily activities of the Department of Orthopedic Research that supports critical operations and functions. Responsible for departmental strategic development and surgeon collaborations. Spearhead key inter- and intra-departmental initiatives.

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

Are you ready to break new ground and leave a collective legacy? As a PET Formulation - Process Engineer, you will provide technical support for process manufacturing, investigating and correcting process-related problems and deviations from standards. This role offers the opportunity to play a pivotal part in evolving our Supply Chain, reimagining how we do things, and creating a lasting impact.

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

Carry out Molecular Biology, Microbiology, Protein experiments following established SOPs and/or guidance of laboratory management. Perform DNA/RNA extraction, quantification, and gel QC. Perform PCR setup for qualitative and quantitative analysis. Report experimental results to project managers in a timely manner. Follow established quality management policies and GLP and GMP practices.

The Project Manager will own project assignments from concept to closure. This will include preparatory documentation, stakeholder engagement, Scope of Work creation, cost estimation, schedule creation, solicitation of funding approvals, procurement activities, construction management, equipment qualification and validation activities, all in a ISO9000, FDA, AS9100, cGMP, ITAR environment. Other activities may be required or assigned depending on the specific project needs. Non-project-related work may include departmental documentation, participation in various initiatives as a team member or Subject Matter Expert, or collaboration with other departments and sites.

The QC Analyst I is responsible for conducting routing analysis of raw materials, in-process samples, and finished products in a strict GMP setting. The position involves working in the QC laboratory and in the manufacturing space on assigned tasks following written procedures and verbal instructions.

Join our dynamic team as a Manufacturing Associate, Downstream! In this role, you'll be a crucial part of our multi-product manufacturing facility, working in strict compliance with cGMP and Standard Operating Procedures. Your responsibilities will encompass various tasks, including production, meticulous documentation, report writing, materials procurement, and equipment scheduling. You'll be instrumental in ensuring the timely production and release of top-quality products. At our company, we value core principles such as Integrity, Adaptability, Innovation, Teamwork, and Passion, all united by a shared mission to enhance patients' lives through the consistent delivery of high-quality biopharmaceuticals. If you're ready to make a meaningful impact, apply now and be part of our journey!

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

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

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

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

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

Perform routine and non-routine microbiological testing and environmental monitoring (EM) in support of sterile manufacturing operations.

Conduct qualitative and quantitative chemical analysis on raw materials, solutions, and components following approved Standard Operating Procedures and test methods in an accurate and timely manner. Ability to work under minimum supervision while meeting deadlines.

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

The Manufacturing Technician III is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. Manufacturing Technician III is expected to fully participate in both departmental projects and any quality working teams which may be applicable. Under the general direction of the lead technician and the overall direction of the supervisor, this position shall be responsible for the hands-on execution of all activities in the production area. Manufacturing Technician III has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills.

The Quality Control Tech 2 works in the Quality Control department and performs general quality control quality assurance testing and review activities in accordance with current Good Manufacturing Practices (cGMP), company policy and safety regulations.

Lead Technician in Quality Assurance assures consistent quality of production by developing and enforcing good manufacturing practice (GMP) systems and support on validation activities.

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

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

Performing routine quality control testing of stem cell products using protocol-defined assays to demonstrate their activity. The assays include culturing and handling of stem cells, primary cells, and basic cell lines for use in flow cytometry and immunocytochemistry (ICC). The position requires routine documentation, data analysis and good communication of results. Good Manufacturing Practice (GMP) documentation and workflow is required. Other duties include instrumentation maintenance, reagent preparation and routine lab support for QC antibody testing using western blot, simple wes and immunohistochemistry.

The responsibilities of this position are label design and optimization, to perform internal audits, and to engage and support other Quality Assurance activities, including but not limited to, Supplier Management, Training Management, and Document Control. Perform additional duties as assigned.

Performing routine quality control testing of stem cell products using protocol-defined assays to demonstrate their activity. The assays include culturing and handling of stem cells, primary cells, and basic cell lines for use in flow cytometry and immunocytochemistry (ICC). The position requires routine documentation, data analysis and good communication of results. Good Manufacturing Practice (GMP) documentation and workflow is required. Other duties include instrumentation maintenance, reagent preparation and routine lab support for QC antibody testing using western blot, simple wes and immunohistochemistry.

The responsibilities of this position are label design and optimization, to perform internal audits, and to engage and support other Quality Assurance activities, including but not limited to, Supplier Management, Training Management, and Document Control. Perform additional duties as assigned.

Biocytogen is a comprehensive research and discovery service provider for biotech and pharmaceutical industry and academic institutions. Its service platform integrates preclinical studies with innovative animal models, CRISPR-based gene editing, antibody discovery, and animal supplies, with current focus on immuno-oncology and oncology. We are looking for a highly motivated research associate with the ability to work both independently and in a collaborative manner. Biocytogen is a fast-growing company and has an abundance of opportunities available for you to grow your career.

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

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

The Research Associate 2 role will support the team by generating high quality data while executing both routine testing and more complex, exploratory research projects. In addition, the candidate is expected to lead certain aspects of projects independently including experimental design, execution, interpretation of results, drafting of technical documents, and communication of data to stakeholders through oral presentations

The QA Engineer is responsible for supporting and facilitating the quality management system of the bioMérieux Philadelphia site. Under the guidance of the Quality Manager, the QA Engineer will work collaboratively with other departments including manufacturing, R&D, and purchasing to ensure compliance to the quality management system. Additionally, this position will assist in executing various site-wide quality projects and initiatives. The incumbent is responsible for monitoring site activities to ensure appropriate quality reporting and compliance to ISO9001:2015 standards. The QA Engineer will have a specific focus on supplier quality management, risk analysis of site processes, continuous process improvement, and sustaining quality management system activities.

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

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

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

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

The engineer role will be a key team member in providing mechanical engineering support in the creation and development of new electrophysiology ablation catheter technologies. As R&D Engineer II, you will support new product development team solutions to multi-faceted customer issues. You will be a part of a high-performance team responsible for the design, implementation, and test of disposable medical devices within our electrophysiology pulsed field ablation single use device portfolio. This critical role will be a part of best-in-class development practices and rigorous, holistic product design in coordination with internal and external partners.

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

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

The Process Engineering Associate, Manufacturing Science and Technology (MS&T) is responsible for supporting clinical and commercial manufacturing production at Cabaletta’s cell therapy CDMO. This position will work very closely with manufacturing partners and requires frequent work onsite at manufacturing facility and occasional weekend and overtime work.

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

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

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

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

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

The Manufacturing Engineer will have the exciting opportunity to join a growing team and work on developing and supporting manufacturing processes for our structural heart products. What you’ll do: Develop and support the manufacturing processes for a new heart valve implant, Assist in a transfer from R&D to Manufacturing through Clinical Use, Identify and act upon areas for manufacturing process improvement, Troubleshoot manufacturing issues and collaborate cross-functionally to implement corrective actions, Provide guidance and perform training to technicians and operators for manufacturing processes, Other responsibilities as determined by project need

The qualified candidate will be working in the Assay Development and Validation Department. The individual will play a critical role in supporting the development, validation, transfer, establishment and successful launch of new molecular assays, instrumentation, and methodologies into the clinical laboratory. Candidate will be responsible for assisting with planning, designing, and performing various laboratory experiments, documentation, reagents receiving, storing and tracking, data analysis, summarization and presentation, transfer of knowledge to other team members and to other departments, training clinical personnel, as well as additional functions fit for the position. Development Associates are expected to contribute both technically and intellectually to optimize quality and efficiency for Caris’ pipeline of development projects.

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

We are seeking an innovative and highly motivated Cell Therapy Manufacturing Specialist to join our Process Sciences team who will contribute significantly to the development and 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 lab operations. 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.

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

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

At Charles River Laboratories, we are looking for a highly motivated and energetic candidate to join our growing business in the CMO industry. The QC Analyst I will perform microbiological testing, static and dynamic viable and non-viable monitoring of classified clean room areas to support planned or in process manufacturing processes. This position, as well as all positions in the Charles River team will require demonstration of Charles River DNA “Characteristics and Behaviors” (Care, Lead, Own and Collaborate).

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

Manufacture of synthetic DNA & RNA compounds. Assist with experiments supporting research in the synthesis of single-cell-barcoded beads, quality control of the synthesized beads, and performing experiments that include basic molecular biology techniques to sequencing experiments to validate and troubleshoot synthesis of DNA oligos to beads. Provide comprehensive technical support for scientists in the company; executing and optimizing ongoing experiments, analyzing results and designing follow-up experiments based on the results, and presenting findings and insights at group meetings. Evaluating research methods, procedures and techniques based on established objectives, conceiving and designing basic experimental protocols to ensure project completion in a timely fashion; recording and organizing data generated from the experiments in clear, concise, and assessable format; perform basic coding and statistical analyses; processing of in-vitro and in-vivo RNA for preparation of RNA-seq libraries for sequencing in Illumina platforms (Mi-Seq including Hi-seq and Next-seq). Experienced in techniques including but not limited to: running agarose gel, polyacrylamide gel electrophoresis, reverse transcription, quantitative PCR, fluorescent microscopy, flow cytometry; maintaining inventories of lab stocks.

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

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

Coastar Therapeutics is currently seeking a talented and highly motivated research associate with molecular biology background to join the multidisciplinary R&D team. The candidate will be responsible for designing and executing experiments in support of the biological membrane coated virus development. The candidate will also be involved in developing and validating collaborating projects to support Coastar’s fast-growing preclinical pipelines. The successful candidate must demonstrate broad and in-depth knowledge of molecular biology techniques. This is a full-time position reporting to the CSO and is located at our corporate headquarter in San Diego.

Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

The Chemist is responsible for and has experience in performing chemical analysis for one of the assigned QC laboratories (Raw Material, Finished Product, Microbiology, ICP, Technical Support) which is responsible for the analysis and disposition of commercial materials (raw materials, finished product release, stability, validation, investigation), and environmental samples, as assigned, and documenting results in accordance with SOPs.

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

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

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

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

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

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

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

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

The Quality Control Analyst I is responsible for performing routine and non-routine analytical chemistry assays of raw materials, in-process samples, finished APIs, and stability samples. This role also participates in special projects, method development/transfers and cleaning study qualifications.

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

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

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

The Research Associate/Engineer - In Vivo/Histology will play a key role in advancing Dimension Inx’s core platform technology and will work closely with the R&D and product development teams to execute in vivo experiments, biological assays, and histological analyses to support new therapeutic product development to improve patient lives. The ideal candidate is a technically focused scientist or engineer with a background in cell and tissue engineering, biomaterials, or regenerative medicine, thrives in a rapidly changing, fast-paced environment, and has experience working on multiple and varied projects simultaneously. The position will report directly to a senior R&D team member. This role will contribute to the progression of collaborative early-stage R&D projects, the testing and development of new biomaterial and biological products, as well as various new product development projects.

The Administrative Research Assistant plays a key role in providing administrative support to the clinical research team. This includes managing day-to-day operations, coordinating schedules, handling documentation, and ensuring smooth communication between team members, clients, and other stakeholders. The position requires a high level of organization, attention to detail, and familiarity with clinical research protocols and regulatory requirements.

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

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

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

Elephas is a Madison, WI based biotechnology start-up company working to build an instrument platform that will inform how clinicians treat cancer patients around the world. We are seeking a highly motivated Data Scientist to join our dynamic team of scientists and engineers developing a platform to predict a cancer patient’s response to immunotherapy. The successful candidate will be motivated to develop analytical, statistical and computational data science methods and deliver data discovery and insights in a fast-paced, collaborative and interdisciplinary environment.

The demand for our service is growing, and to meet that demand, we are recruiting Lab Operators looking to explore opportunities in the biotech space and grow with our organization. Qualified candidates will receive comprehensive lab and safety training, allowing them the ability to run protocols in our Austin facility. These protocols are critical to sustaining the high-quality operations of the facility and provide experience working in ECL’s unique, process-driven lab environment with our integrated software tools.

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

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

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

The Quality Associate Specialist, Product Release, under close supervision, reviews all pertinent records, including Batch Production Records and laboratory Certificates of Analysis to confirm accuracy and, with guidance, makes the determination of acceptability for product release. In addition, confirms that all related Quality events such as CAPAs, Change Controls, etc. are closed prior to releasing the product. Partners with other departments to ensure that errors are addressed and corrected. Identifies errors that have potential product impact, escalates to supervision, and takes action to place lots on Quality Hold as needed. Ensures release meets internal requirements and is performed in a timely and accurate manner. All incumbents are responsible for following applicable Division & Company policies and procedures.

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

Perform biochemical testing on samples including, but not limited to HPLC, CE, and physical properties, Use ALCOA to document test results in electronic notebooks.

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

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

The Analyst primarily performs analysis of bulk samples using PLM for asbestos. Analyst prepares and analyzes environmental samples according to scientific methodology in compliance with company Quality Assurance programs and SOP’s, and must be knowledgeable of both job-specific routine and complex analyses. The analyst validates and reviews data for accuracy, and enters laboratory data into the LIMS that ultimately generates required reports to clients. Schedules sample workload according to due dates and sample hold times, and must be knowledgeable of the job-specific laboratory testing equipment, requiring the exercise of discretion and judgment in its operation.

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

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

The Plant Engineer I acts as system owner and subject matter expert (SME) for assigned area(s) to include but not limited to infrastructure, utilities, and process equipment. He/ She will ensure that the assigned systems are in a state of operational readiness by ensuring that preventive maintenance is carried out on time and in full, any issues are documented and investigated, corrective and preventive actions are implemented. He/ She provides technical expertise to maintain and continuously improve assigned areas to improve reliability, reduce downtime, minimize costs and ensure technical means for safe and high-quality operation.

The Metrology Associate I will service custom and off-the-shelf laboratory instrumentation and equipment. This role will be responsible for, assembly, installation, calibration, routine maintenance, investigation and diagnosis of failures, repair, requalification, and filing service reports. The Metrology Associate I will work with colleagues to ensure proper instrument function and maintenance.

Create and maintain the lowest cost, highest quality machining & manufacturing processes, tooling and supporting documentation for all parts produced.

EyePoint is seeking a motivated Process Engineer I with excellent interpersonal skills to join our team. This person will be responsible for process sustaining and improvement of all components, device and packaging related projects. This position requires the application of continuous improvement, equipment oversight, trending, layout plans, testing, data analysis and report writing to resolve and improve manufacturing efficiencies. Candidate must be able to effectively collaborate with internal R&D, Quality, Regulatory and Operations departments and with external vendors and suppliers to deliver against project timelines and maintain process sustaining activities. The ideal candidate possesses the ability to develop credibility and trust as a technical resource to contribute to the company’s growth, productivity, and innovation.

The Engineer, Test (Medical Device) assists with all phases of systems performance verification and validation activities for infusion devices to support product development, product changes, and regulatory submissions. This includes prototype evaluations, planning, and execution of informal and formal verification cycles and reporting.

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

A Scientist I in Quality Control is responsible for an intermediate level of expertise in analytical chemistry, chromatographic methods of analysis and instrumentation, including troubleshooting. Directs and provides guidance to associate scientists.

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

We are seeking a highly motivated and detail-oriented Associate Scientist to join our Pharmacokinetics (PK) group. The successful candidate will support bioanalytical method development, validation, and sample analysis using ligand binding assays (LBA) to assess pharmacokinetics for preclinical and clinical studies. This role requires expertise in bioanalytical techniques, data analysis, and regulatory compliance.

The Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally.

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

The Quality Assurance (QA) Analyst II, under general direction, will be responsible for review and/or approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and procedures; Assisting in and performing product related activities; Assisting in and performing Quality audit functions; Identifying process and Quality System improvements; Acting as a QA liaison internally.

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

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

The QC Analyst will be responsible for routine and non-routine QC sampling and testing for the quality of products manufactured for our clients. QC is responsible for execution of the Environmental Monitoring (EM) program in place to monitor Genezen's controlled manufacturing environments (cleanrooms) as well as monitoring of utility systems including Water for Injection (WFI), Pure Steam, Purified Water, Compressed Air and Gas systems. These activities are all performed in accordance with cGMP guidelines and are supported by departmental and inter­departmental policies and standard operating procedures (SOPs). This position is based at Genezen’s state-of-the-art facility in Lexington, MA. This role supports daily operations as well as occasional weekend and holiday operations. This may include but is not limited to in-process monitoring and testing, lot release testing, and stability testing. Supporting activities for quality systems: utility monitoring excursions, non-conformance, deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls may be required.

The position will work within the Upstream Processing group and performs the following activities while executing upstream operations: Preparation of stock solutions, buffers and media. Filtration of stock solutions, buffers and media. Set-up and operate disposable fermenters / bioreactors and other disposable bioprocess equipment including depth filtration. Passage and expansion of microbial and mammalian cell lines. The position also supports relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

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

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 a 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 are seeking a highly skilled and motivated Electrical Engineer to join our rapidly growing Digital Health team. You will work closely with a dynamic team of electrical, software, and mechanical engineers to conceptualize and commercialize innovative medical devices to meaningfully impact the lives of patients with musculoskeletal disorders. The ideal candidate will have a strong background designing, building, and testing embedded electrical systems, including firmware design and development. This role requires a balance of creative thinking, analytical design, hands-on prototyping and testing, and systematic product development.

Our rapidly growing medical robotics division is searching for enthusiastic electrical engineers wanting to make a difference. Our skillful engineers develop medical robots by working with top surgeons and cross-functional engineering teams. The Electrical Engineer will be part of the electrical team responsible for designing and implementing electronic circuits and electro-mechanical sub-systems for surgical robotic products. The position will be a hands-on one with the individual capable of creative and systematic product development with minimum supervision.

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

GigaGen, a subsidiary of Grifols, seeks a talented, highly motivated Research Associate to support the process development of our diverse antibody therapeutics pipeline. This will include cell line development, cell culture optimization, and bioreactor production, as well as purification and analytical characterization of antibodies and antibody derivatives. This position will offer exposure to drug development, from early research through development/manufacturing, with ample opportunity to learn new methods, design experiments, and present your work.

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

The Process Engineer demonstrates consistent application of technical knowledge and/or regulatory knowledge in the Process Engineering discipline. Develops and implements solutions. Leads projects of larger scope (or portions of projects) and is often called upon by peers for guidance. Directs project or discipline teams. Meets customer needs in support of business goals.

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

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

Assisting and performing efficacy and PK-PD studies and developing new in vivo/ ex vivo assays and models with minimum supervision, as needed. Help to design, optimize and execute of pharmacology experiments for compound screening, compound mode of action and efficacy in mechanistic and disease models, e.g. syngeneic and xenograft tumor model, acute and chronic autoimmune/inflammatory conditions, and analyses and reporting of experiments or implantation, blood/tissue collection, etc. Assist with and perform other experiments as required. Working with the team to perform assay development, optimization, and validation projects. Following SOPs to perform compound receiving, registration, and management. Help to manage lab coordination.

Being able to wake up in the morning knowing that your work makes a difference in the lives of others - that's the best kind of motivation. If you're looking for a company where you can combine a passion for improving patient care and outcomes with the skills and experience you've spent a career developing, then HemoSonics may just be your perfect fit! This role is on-site in Durham, North Carolina - working remotely from other parts of the country is not an option for this role, so all candidates must be local or planning to move for this position.

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

Perform functions within the Microbiology Laboratory and/or conduct critical microbiological analysis on test articles from all stages of the manufacturing process from incoming raw materials to finished goods. The duties also include equipment maintenance and LIMS management.

The QA Inspector monitors in-process product quality for Filling and Inspection and Packaging of parenteral products. The QA Inspector performs visual and functional testing of products against statistically based sampling plans. In addition, the QA Inspector performs routine inspection and testing of components following Standard Procedures and specifications as required by production schedules. In performing the above duties, the individual is responsible for accurately and clearly documenting test results following cGMPs. This position participates in rotation for weekend coverage and as needed during the work week.

Engineer I, Quality will support the ICU Quality Operations Department and report to the Quality Operations Manager. They are responsible for sustaining manufacturing and validations through adherence to established design control processes, good quality and documentation practices. The key responsibility of this position is to exercise judgement and act while adhering to defined quality procedures during project support & improvement. Engineer I, Quality will complete basic projects assigned by more experienced engineers and managers. They work on projects/matters of limited complexity in a support role while being closely managed.

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

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

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

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

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

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

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

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

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

This position is part of the Process Development Department located in Coralville, Iowa and will be on-site. At IDT, we are one global team. We celebrate our differences, engage in healthy debates, and are inclusive. Together, we accomplish great things.

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

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

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

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

We are seeking an Associate Scientist to join Q² Solutions, IQVIA’s laboratory business at Valencia, CA. Responsible for conducting routine analysis and laboratory testing procedures while ensuring compliance with SOPs, regulatory guidelines, and quality standards. This position involves data analysis, documentation, and collaboration within a fast-paced laboratory environment.

As an Immunoassay Associate Scientist, you will execute laboratory experiments with precision, contribute innovatively to scientific procedure design, and uphold the highest standards of Good Laboratory Practices (GLP) for our clients. You’ll not only set up and conduct experiments but also manage laboratory equipment, ensuring protocols are meticulously followed under the guidance of a dedicated lab services manager, researcher, or scientist.

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

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

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

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

Responsible for leading technical support activities for GMP Manufacturing Operations in a multi-product, large scale biopharmaceutical facility. This role will support, but not limited to the following: Drafting, routing, and revision of manufacturing batch records, support records, and standard procedures. First line of defense for manufacturing events. Individual will assess, provide, and help implement immediate corrective and preventative actions. Provide manufacturing process support during on-going shop floor execution as needed. Support new equipment enrollment workflow from purchasing to qualification as needed. SME support on critical laboratory equipment supporting manufacturing operations. Additionally, SME will lead and manage all activities and event related to critical laboratory equipment. Support safety initiatives, compliance, and quality requirements.

The Validation Engineer I/II will be responsible for facilitating the validation lifecycle process for the Validation Department to ensure all equipment and systems are in a qualified state suitable for the intended use. This may entail, assisting with the planning, development, project management, and execution of life cycle engineering and validation lifecycle documentation elements of engineering and validation lifecycle design, commissioning, maintenance, qualification, and the interfaces with quality system lifecycle compliance requirements. This position will provide support for more than one area of subject matter expertise for validation disciplines which may include: Facilities qualification, Utilities qualification, Equipment qualification, Manufacturing process control system qualification and Cleaning validation.

Responsible for leading technical support activities for GMP Manufacturing Operations in a multi-product, large scale biopharmaceutical facility. This role will support, but not limited to the following: Drafting, routing, and revision of manufacturing batch records, support records, and standard procedures. First line of defense for manufacturing events. Individual will assess, provide, and help implement immediate corrective and preventative actions. Provide manufacturing process support during on-going shop floor execution as needed. Support new equipment enrollment workflow from purchasing to qualification as needed. SME support on critical laboratory equipment supporting manufacturing operations. Additionally, SME will lead and manage all activities and event related to critical laboratory equipment. Support safety initiatives, compliance, and quality requirements.

Join a highly technical analytical team in a dynamic work environment where you will participate in contracted client analytical programs as a member of the Analytical and Formulation Sciences (AFS) Department. The individual in this position will be responsible for executing experimental protocols and performing data analysis in biopharmaceutical laboratories.

As a Microbiologist I, you will play an essential role in protecting product quality and ensuring a contamination-free environment. Your daily work will directly support the safety and reliability of our pharmaceutical products through environmental monitoring and microbiological testing. By mastering aseptic techniques and partnering closely with experienced professionals, you will help maintain high laboratory standards, ensure regulatory compliance, and build a strong foundation in microbiological quality control. Your attention to detail and commitment to excellence will contribute to patient safety and support our mission to deliver life-changing therapies with integrity and care.

Kite Pharma is seeking a creative and highly motivated Sr. Research Associate to join our growing vector process design team in Santa Monica. In this integral role, you will contribute to the company's pipeline development for hematopoietic and solid tumor malignancies by supporting the development, scale-up, process characterization, and technology transfer of the lentiviral vector process.

Krystal Biotech, Inc is seeking a highly motivated and dynamic Bioprocess Engineer to support our product manufacturing at our Pittsburgh GMP facility. This role is critical to our make a meaningful difference in the lives of underserved patient populations having rare diseases. Quality, safety and on-time delivery is a must to be successful in this role! The ideal candidate will have foundational experience in upstream and/or downstream biologics or gene therapy manufacturing.

Krystal Biotech, Inc. is seeking a Clinical Trial Associate to support our Clinical Operations Team. The Associate's responsibilities will entail, but not be limited to, assisting with the management and inventory of clinical supplies, ensuring proper materials are available at clinical sites in a timely manner, and working with the Clinical Operations team to support multiple Clinical Trials. Conducting reviews of trial data and follow GCP/ICH protocols/guidelines. Will require travel to Clinical sites, including up to 50% of the time, during peak periods.

A project automation engineer to assist in design and start-up of a new manufacturing facility. The project automation engineer will work directly with the Site Head during the project phases and then transition to an operational role in the plant. The Automation Engineer is responsible for the design, commissioning, and operation of key KKNA Manufacturing Facility automated systems.

The Associate Chemist is responsible for analytical, environmental and physical testing He or she also performs testing on raw materials and compounded products. This person will also participate in the development and formulation of new products under the direction of a Chemist or Senior Chemist. The Associate Chemist may provide any necessary technical support to various other departments. In addition, he or she is responsible for any other task the Chief Technology Officer deems necessary.

Performs initial, in-process and final inspections during manufacturing/packaging of product; resolves inspection findings with Packaging Manager and /or QA Manager. Collects product samples for product release testing, process validation testing and product stability as applicable and prepare labels at completion of packaging. Prepares documentation and forward samples to QC Lab for required testing; records information on batches in-process of testing on QC board; notifying QC of any urgent testing. Monitors incoming materials as received in Quarantine. Reviews material received paperwork and compare to material received for accuracy; notifying Materials Department to call supplier if CofA has not been received or CofA is incomplete. Coordinates with production areas to anticipate material usage to meet required schedule. Performs other related duties as required.

This is an exciting opportunity for growth within the lab industry! Lighthouse Laboratory Services is seeking a highly motivated and experienced Full Time LCMS technologist to join our laboratory in Dickson, TN. The technologist will be responsible for the day-to-day operations of the toxicology laboratory, sample prep and processing, ensuring the delivery of high-quality testing services, and daily laboratory operations.

We are seeking a Process Engineer to support the pilot plant facility in Lebanon with a focus on peptide and oligonucleotide synthesis. This position involves solving technical challenges with equipment design, developing and sustaining process knowledge, optimizing processes, and managing equipment capabilities.

The Manufacturing Associate will be responsible for performing routine manufacturing activities across GMP manufacturing areas, including: Cell Culture, Downstream Purification, and Fill & Finish at the Lebanon Advanced Therapies, LP2 site. Initially, the Manufacturing Associate will be responsible for supporting execution of equipment qualification, developing site operations procedures and setting up production areas. During this initial project delivery/startup phase of the project, roles will be fluid and dynamic. Once the plant is operational, the Manufacturing Associate will be responsible for execution of production activities on their shift under the leadership of the shift supervisor.

The Manufacturing Scientist provides the technical support required to achieve the reliable and compliant manufacture of the Active Pharmaceutical Ingredient External Manufacturing (API EM) portfolio which includes raw materials, intermediates, enzymes and bulk drug substances. The API EM Manufacturing Scientist executes technical projects (experimental, modeling and/or production data analysis) to improve and optimize process control, yield, purity, and/or productivity. In addition, the manufacturing scientist should be capable and technically independent in setting up and executing a variety of experiments at the laboratory scale and conduct research on manufactured product for process improvements and troubleshooting in the technical services and manufacturing sciences laboratory.

We are looking for an Associate Scientist, Quality Control. In this “hands-on” role within the Quality Control Lab, the Associate Scientist will join a talented and collaborative team that welcomes input and suggestions to help continue Liquidia’s upward trajectory at the most exciting time in the Company’s history. Critical to success are a scientific laboratory background, ability to follow CGMP documentation requirements, and excellent communication skills. The Associate Scientist will conduct laboratory analysis of raw materials and intermediates in support of Liquidia’s lead product candidate.

Join Lonza as a Manufacturing Associate Level I for a remarkable chance to contribute to producing therapeutic proteins in New Hampshire, USA. Work with a top team to implement innovative ideas for improving lives under cGMP conditions! Working nights from 7pm-7am on a rotational schedule.

Become an essential part of a world-class team at Lonza AG as a Lab Technician in Greenwood, SC, USA! This outstanding opportunity allows you to support critical R&D functions, formulation development, and testing. Join us in our ambitious mission to improve lives through science.

The role of Assistant Scientist within our Quality Control Release department conducts routine general chemical and/or biological testing of materials and products for in-process, release and stability purposes, in compliance with all applicable procedures and regulations. A variety of duties are performed relating to the efficient and effective functioning of the Quality Control lab.

Join us in our pursuit to make a difference. Together, we can change the future of medicine! This position reports to the Vice President, Quality and Compliance and is responsible for providing quality support of product development and clinical trial activities and associated functions performed by external contract research, development and manufacturing organizations. This position also supports internal quality systems and compliance functions. The Quality and Compliance Specialist is expected to execute established processes involving quality assurance, quality systems and compliance.

The Quality Analyst II has responsibility for Product Release and Maintenance of Monthly Quality Metrics and Daily Notification to Management. They provide support for customer inquiries, gap assessments, batch record review, and label preparation as assigned.

Participates in duties associated with manufacturing of MatTek tissue models according to SOPs where applicable. May also perform duties assigned under Laboratory Assistant, as needed.

Medtronic is hiring in Woolwich County, here our employees are helping us deliver on the extraordinary. We actively seek a diverse workforce at every level: We require fresh ideas and inclusive insights to maintain our position as an innovative industry leader. That’s why we actively seek, attract, and develop employees who are patient-centric, passionate, and who reflect the wide variety of life experiences found among our patients. 

In this exciting role as a Quality Systems Specialist – CAPA Specialist supporting the Tempe Campus - you will have responsibility for compliance to the Corrective and Preventive Action (CAPA) processes and Medical Device regulations and requirements, serve as a CAPA subject matter expert; provide guidance to CAPA owners and CAPA Board members to develop CAPA activities and conduct assessment of CAPA documentation. The Quality System CAPA Specialist will ensure compliance with Medtronic policies, FDA regulations, ISO 13485, and other requirements by rigorously assessing CAPA activities and documentation. They will participate in CAPA Board activities, provide guidance and mentorship on CAPA processes and tools, and report on CAPA metrics. Additionally, they will support the development and implementation of CAPA procedures, software, and training, and assist in internal and external audits and inspections.

This position will lead all testing efforts for the Translational Research System team on Neuromodulation & Pelvic Health Implantable products such as cutting-edge neurostimulator systems for Deep Brain Stimulation, Spinal Cord Stimulation, and Sacral Nerve Modulation. The individual will support all test-related phases of development including definition, design, troubleshooting, characterization, and verification of medical device research systems. The individual will be an integral part of the R&T organization delivering the highest quality, life changing technology to our patients. This role requires a strong background in testing, problem solving, and issue investigation with a passion for improving healthcare through technology.

Translational Medicine is responsible for early clinical development of novel therapeutics, working in close collaboration with Discovery Sciences and late-stage Clinical Research across all therapeutic areas. Our team is focused on innovation and dedicated to translating breakthrough science into innovative medicines that extend and improve the lives of patients worldwide. Through clinical trials, we ensure the safety and efficacy of our pipeline and existing products to produce safe, effective, innovative medicine.

The Associate Quality Control Chemist at MilliporeSigma will evaluate products according to established protocols, provide technical support to others and perform operations in support of the group and department. The QC Chemist is also responsible for the general maintenance and upkeep of the analytical instruments that reside in the QC labs, and assists with managing existing service contracts and the onboarding and retirement of instruments.

The Associate Production Scientist role is focused on creating manufactured kits of reagents to support Multiplex, ELISA, and RIA kits in the Immunoassay Platform Solutions (IPS) portfolio in a timely manner.

MilliporeSigma in St. Louis, MO is seeking a Manufacturing Compliance Specialist for the Ewing Facility in St. Louis, MO. This Compliance Specialist will be responsible for supporting the Ewing operations through the management of quality records (deviations and CAPAs), managing the creation and updates of operating procedures, and assisting label issuance/management for production. This role will work collaboratively with QA, QC, Operations, Engineering, Validation, Process Development and Maintenance while adhering to GMP principles.

The Quality Assurance (QA) Associate will support QA processes, programs, and conduct QA activities. This position will uphold standards, methods, and procedures for all stages of production. This position will identify continuous process improvement areas, in compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GLP) processes and documentation for quality control activities. This requires excellent technical skills and abilities, analytical and mathematical skills, organizational and time-management skills, verbal, and written communication skills, plus ability to apply attention to detail.

The Quality Control Analyst Chemist for Mikart, LLC is responsible for conducting analyses on various components, in-process materials and finished dosage forms.

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

At MMT, our objective is to provide world-class solutions for precision hole making applications and contract medical device manufacturing. Each position contributes to the success of the company through accountability, responsiveness, and a solutions-oriented mindset. Working in concert with the appropriate internal and external resources, the Technical Sales Engineer will primarily focus on being a technical expert across all offerings within SYNEO’s Cutting Tools and Specialty Manufacturing Divisions. This position is required to perform Sample Material Evaluations, Inspections, Data Collection, and give feedback for application specific tooling or Specialty Manufacturing processes. The position requires close collaboration with internal manufacturing stakeholders, engineering, and sales resources to develop and implement recommendations that meet or exceed customer expectations.

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

Support the activities for reagents used in the Operations Department’s Clinical Laboratories. Executes the preparation and qualification of molecular diagnostic reagents. Performs Quality Control tests on new incoming shipments of raw materials and small-scale manufacturing procedures (formulations and dispensing) reagent. Reviews data obtained for compliance to specifications and reports abnormalities. Maintains and improves QC documentation pertaining to raw material specification, reagent qualification, and QC testing. Support Incoming Quality Control activities as needed.

The Research Associate 1, performs laboratory procedures of varying complexity contributing to cross functional activities as part of the Sample Processing team. Works primarily with R&D Scientific Operations, a multidisciplinary team within the research and development department.

Natera is currently seeking a Clinical Laboratory Associate to analyze laboratory specimens following the standard methods and procedures while maintaining equipment and instruments in good operating condition by troubleshooting malfunctions as needed.

Assists in analyzing specimens and maintains equipment in good operating condition.

We are in search of a collaborative, passionate scientist with sound scientific knowledge and excellent technical skills in cell-based in-vitro assays, molecular biology and analytical sciences for AAV gene therapy and biologics. In the biologics lead optimization team, you will be responsible for performing routine analytical tests and developing/optimizing analytical methods to support the development and manufacturing of AAV based gene therapy products and biologic therapeutics. In this role, you will collaborate across multiple groups including process development, CMC, research, as well as CROs to ensure all applicable analytical test methods are appropriate for the stages of preclinical & clinical development. This is an excellent opportunity to utilize, contribute and advance the ideal candidate’s laboratory skills in a progressive, state-of-the-art and diverse facility.

The Mechanical Engineer I will collaborate with team members to design and refine cutting-edge medical devices, contributing to product testing, validation, and optimization. Working closely with management, quality assurance, supply chain, and engineering teams, the Mechanical Engineer will oversee all stages of product development, encompassing mechanical design, materials sourcing, prototype fabrication, and the planning and implementation of characterization tests. Responsibilities will also include the development of test protocols, active participation in product testing, and the preparation of comprehensive test reports

The Manufacturing Associate I is responsible for the execution of production activities for early phase small molecule and/or biological programs within a GMP environment. The incumbent works cross-functionally with internal departments and external resources on manufacturing related issues. The Manufacturing Associate I supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

The Radiopharmaceutical Manufacturing Associate performs duties to support the development and manufacturing of radiopharmaceuticals for NorthStar operations. This includes equipment preparation, product dissolution, and dispensing of medical radioisotopes while complying with procedures, instructions, and prescribed routines. All duties and responsibilities will be completed in compliance with applicable regulatory agency standards. This position supports production in a 24-hour manufacturing facility which means your schedule provides days off during the week when weekend work is required. Early morning, late evening, weekend, and some holiday work will be required with occasional overtime. Requirements for this position include the ability to work 1st, 2nd, and 3rd shifts during the training period (several months).

Nova Biomedical is hiring a Quality Engineer I in our Manning Road, Billerica, MA facility. This role will support Quality Assurance activities within the corporate Quality Management System (QMS). Responsibilities include providing expertise and general oversight for the management and improvement of design and development, validations, quality planning, internal auditing, investigations, process controls, change management, quality records, corrective and preventive activities, data management, employee training, and other duties as assigned.

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

We are seeking a highly motivated and detail-oriented Quality Control (QC) Technician to support both Microbiology and Chemistry functions at our We are seeking a highly motivated and detail-oriented Quality Control (QC) Technician to support both Microbiology and Chemistry functions at our radioisotope production site. The primary responsibility of this role will be to perform routine quality control testing and analytical functions to ensure the production of high-quality radioisotopes. The QC Technician will work closely with the Quality Control and Production teams to maintain regulatory compliance, meet GMP (Good Manufacturing Practices) standards, and ensure the safety and efficacy of products produced at our Indianapolis Isotopes facility.

This position has primary responsibility to support Quality Control operations in the microbiology, analytical or inspection area. This position requires strict adherence to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. This position carries out routine QC testing and may support sampling, investigations, validations, projects and other related support activities for the manufacturing facility and process. This individual works with supervision on routine tasks and detailed instruction on new tasks.

This position has primary responsibility to support Quality Control operations in the microbiology, analytical or inspection area. This position requires strict adherence to cGMPs, established manufacturing practices and procedures, and compliance with quality regulations and guidelines. This position carries out routine QC testing and may support sampling, investigations, validations, projects and other related support activities for the manufacturing facility and process. This individual works with supervision on routine tasks and detailed instruction on new tasks.

As a Phage Lab Technician, you'll gain hands-on experience in a dynamic environment focused on customer support through our phage testing service.

Lead recovery optimization in lab and production scale. Provide technical support for troubleshooting efforts and process improvement initiatives. Identify and capture new opportunities for production process improvements. Contribute to closing global gaps on focus products. Ensure projects are aligned with Global Optimization Network guidelines. Lead and motivate project teams towards achieving ambitious yet achievable goals. Support the professional development of peers through scientific guidance. Plan and coordinate experimental work for small and large-scale trials. Conduct experiments and evaluate data to ensure project expectations and deadlines are met. Effectively communicate technical insights and project progress. Recommend improvements in recovery pilot scale equipment and processes

The Manufacturing Technician I will assist the Manufacturing team and report into the Associate Manufacturing Manager. This individual will sit out of our San Diego, California.

Nurix Therapeutics seeks a motivated Research Associate to join the Analytical Development and Quality Control group. The Research Associate will operate and maintain lab equipment and instrumentation, conduct sample receipt/analysis/data reporting, and communicate analytical results internally.

We are hiring a Validation Engineer to be on the cutting edge of automated validation techniques. You will be responsible for implementing our validation solutions while working with industry-leading companies. Ideal candidates are experts on the requirements of 21 CFR 11, have excellent critical thinking and interpersonal skills, and are motivated to meet client needs for compliance. If you are an A-level engineer who enjoys the challenge of solving real-world compliance problems then we would like to talk with you.

The Field Service Engineer (FSE) services and maintains all product lines for Olympus America medical products. Under supervision of Manager and Senior FSE Trainer, the FSE will service and provide expert level technical support to assigned equipment.

This is a 1st shift-based position, working on-site Monday through Friday, from 7am-3:30pm. The Cell Therapy Production Associate, Oncology plays a critical role in the production of Orca Bio’s life-saving cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. Reporting into the assigned manufacturing shift supervisor, the job involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. The role collaborates closely with Materials Management, Quality Control (QC), and Quality Assurance (QA) to carry out GMP manufacturing runs as part of a cross-functional team.

This is a 3rd shift-based position, working on-site Monday through Thursday, from 9pm to 7:30am. The Cell Therapy Production Associate, Oncology plays a critical role in the production of Orca Bio’s life-saving cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and aseptic production techniques. Reporting into the assigned manufacturing shift supervisor, the job involves repeatedly executing manufacturing processes, cleaning and maintaining production equipment and workstations and documenting production activities in a highly regulated environment. The role collaborates closely with Materials Management, Quality Control (QC), and Quality Assurance (QA) to carry out GMP manufacturing runs as part of a cross-functional team.

This is an entry level position. The Associate will perform all activities involved in the aseptic processing of a living product (Apligraf), under the direct supervision of the Apligraf Team Leader/Apligraf Supervisor/Manager. The Apligraf Associate I will support the Apligraf Manufacturing department by performing the tasks that will assure the safe and timely processing of Apligraf, working in both a Class 100 and Class 10K cleanroom.

Outpace Bio is seeking an Research Associate II/Senior Research Associate to support development of analytical assays and technology transfer to CDMO partners for the GMP production of lentiviral vectors and CAR/TCR drug products. As a member of the Technical Operations team, the Research Associate II/Senior Research Associate will contribute to analytical development projects supporting CMC activities, authoring analytical development reports, advancing early phase analytical method transfer from the Outpace R&D team, and conducting hands-on, technical laboratory work. This position will report to the Senior Scientist, Analytical Development and will work closely with R&D functional groups (Platform, Immunology, CAR T development) as an integral part of project teams. Key contributions expected from this role include novel assay development, support for internal process and assay technology transfer to CDMOs and CROs, communications to internal and external stakeholders, and providing necessary technical support for regulatory submissions.

We are hiring for multiple Microbiologist II Technicians to support the Microbiological analysis of products, stability samples, validation samples, raw materials, and environmental samples through testing, data analysis/interpretation, method validation and continuous improvement projects.

We are looking to fill a Scientist 2 or 3- Device Verification Scientist position working as a full-time employee of Parexel on long-term assignment onsite at one of our clients located in West Point, PA. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship. The Center for Packaging and Device Analytics (CPDA) provides physical analytical expertise in support of production and commercialization of packaging and combination device products.

We are looking to fill a position for a Scientist 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 III - Process Development and Characterization Support position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in West Point, PA. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship. Support of standard analytical testing of samples from vaccines and large molecule process development/characterization. Other potential opportunities include method development/optimization.

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

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.

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.

Perrigo is now hiring for a Validation Engineer who will work out of our facilities in Holland, Michigan. The Validation Engineer will primarily be responsible for preparing and reviewing plans, protocols, reports, and studies associated with validation activities (Process, Packaging, Cleaning, and Equipment).

At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California.

The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality Control activities associated with clinical and/or commercial product, raw materials, and validation.  Key responsibilities are performing GMP tasks associated with maintaining compliant Quality Control and Stability laboratories; testing, analyzing, interpreting, and trending results; and creating, reviewing and approving documentation. Individual should have knowledge of current Good Manufacturing Practices (cGMP), Laboratory Information Management System (LIMS), Microsoft Office™ applications specifically Word and Excel, analytical techniques and instrumentation, Lean Six Sigma concepts, and Lean Labs.

Executes the activities of QC Microbiology Laboratory by following approved microbiological and chemical test procedures and ensuring their delivery in an accurate and timely manner following proper safety precautions.

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

We are on the hunt for bold, innovative thinkers who are ready to help push the boundaries of science and make a tangible difference in the world. The successful candidate will focus on document management and quality operations within the cardiovascular pharmaceuticals sector. Your expertise will support continuous improvement initiatives and ensure compliance with industry standards.

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

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

This position works within the Forensic Toxicology Laboratory and is responsible for all aspects of testing of donor specimens including specimen preparation and instrument operation.

Participates on a team of scientists in the development and transfer to manufacturing of processes to purify, characterize and modify enzymes, antibodies and other proteins. Candidate will be expected to work in the laboratory.

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

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

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

The Microbiologist I is responsible for all duties related to performing environmental monitoring, personnel monitoring, microbial enumeration, microbial identification, and sampling of utilities. The Microbiologist I is also responsible for performing all the microbiological testing related to raw materials, utilities, and in-process product testing. Other responsibilities include data entry, data review, ensuring calibration of equipment, maintaining and ordering inventory of laboratory supplies, and maintaining the Microbiology laboratory by ensuring its cleanliness and order.

The Project Engineer will execute and provide engineering support for the procurement, enrollment, and installation of equipment and systems. They will also support validation and commissioning activities. This critical role will develop and review related documentation and collaborate with Quality Assurance to ensure adherence to world-wide regulatory requirements and corporate standards.

The Quality Control Microbiology, QC Analyst will be responsible for collecting environmental samples in clean room areas to support manufacturing operations, sample management activities, and testing of cell therapy in-process and release product samples. The person will be responsible for reporting data and writing/revising standard operating procedures (SOPs) and test methods. This position will also provide support to assist the QC group and partner project teams during technology transfer, analytical method qualification, and routine GMP testing. The QC Analyst I/II, Microbiology will partner with the QC analytical team, interface with multiple groups including manufacturing, and must have the ability to assess method suitability, interpret results, perform tasks independently, and troubleshoot. Identifies and supports initiation and completion of deviations, corrective and preventative actions, and laboratory investigations in compliance with all applicable quality systems and current cGMPs.

As a Technical Support Specialist, you'll play a critical role in empowering researchers worldwide. You'll work closely with scientists to provide expert guidance, troubleshoot technical issues, and contribute to product development.

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.

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

The incumbent manages all technical aspects of assigned products and/or new processes in manufacturing. This includes preparing batch log records and cleaning log records, supporting production, conducting investigations, implementing corrective actions, and improving yields and cycle times.

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

Smithers PDS LLC (Pharmaceutical Development Services) offers a comprehensive range of pre-clinical and clinical services for all phases of drug development, including support for development of drug delivery devices, and medical and pharmaceutical packaging testing. Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP, GCP, and CLIA compliant laboratories. We are seeking a talented Associate Scientist to join our team in the Gaithersburg, MD laboratory.

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

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

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

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

We are currently seeking a Quality Control Technician for testing products, such as antibodies and proteins, following SOP’s and ISO requirements.

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

We are currently looking for a Quality Control Analyst to perform analysis of raw materials, finished product, stability samples, and R&D materials as part of the quality team. This will include understanding the basics of proteomics and DNA, handing sensitive materials, performing statistical analysis on results, and technical writing to report results as part of supporting multiple departments to achieve a common goal

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

The Quality Analyst is responsible for assisting in administration of the quality management system at a site to assure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. This role leads complaint/CAPA investigations, supplier quality improvement initiatives, continuous improvement initiatives and countermeasures 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. The Analyst also supports production and quality operations by coordinating and performing problem-solving investigations, pre-reviews and final acceptance/run release of processing runs that contain non-conformances. Responsible for the activities related to quality and regulatory compliance to ensure all product processing requirements are met in accordance with Customer specifications including calibrations, dosimetry results, generation of test methods, audits, scheduling, validations, record keeping and reporting.

The Quality Engineer in our Conroe, Texas facility 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. In this role the Quality Engineer 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, the Quality Analyst is responsible for assisting in administration of the quality management system at our Minneapolis site to assure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. This role executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems. The Analyst also supports production and quality operations by coordinating and performing problem-solving investigations, pre-reviews and final acceptance/run release of processing runs that contain non-conformances. You will be responsible for the activities related to quality and regulatory compliance to ensure all product processing requirements are met in accordance with Customer specifications including calibrations, dosimetry results, generation of test methods, audits, scheduling, validations, record keeping and reporting.

We are looking for an Associate Scientist to join the In Vivo Discovery group to conduct proof-of-concept, validation, and pharmacology studies to support multiple pre-clinical programs. You will be passionate about scientific discovery, undeterred by bold challenges, and enjoy working as a team to develop the next generation of mRNA medicines. You should be highly organized, a critical thinker, adaptable to changing priorities, and possess a strong ability to collaborate effectively with teams of diverse backgrounds.

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

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

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

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

The Quality Control Associate I, is responsible for supporting the control and management of samples within QC and performing routine testing of in-process, release, and stability samples following written methods and procedures. The position will work as part of the Analytical Development (AD) / Quality Control (QC) group to support the team responsibilities. Adherence to GMP/ GDP guidelines and ability to follow SOP’s is required.

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

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

We are looking for a highly skilled Research Associate to join our Biological Modeling team within the Biorepository. Our CAP accredited Biorepository develops complex, microenvironment-rich human tumor models for use in a range of studies with our academic and pharmaceutical partners to develop next generation cancer therapies. The ideal candidate will have a strong understanding of immuno-oncology, cell biology and experience with sterile tissue culture and molecular techniques. Prior laboratory experience with mouse and human primary cells and training in CRISPR gene editing approaches is preferable. The successful candidate will be responsible for developing, maintaining and archiving tumor organoid cultures, as well as working with multidisciplinary teams supporting functional assays.

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

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

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

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

The Process Engineer is essential to ensuring the seamless integration of manufacturing processes with quality management systems, driving operational efficiency, product excellence, and regulatory compliance. This role combines process engineering expertise to optimize production workflows and resolve technical challenges with quality engineering responsibilities, including maintaining product quality, managing non-conformances, and supporting continuous improvement efforts. This individual is responsible for supporting the development and implementation of robust procedures, track key performance indicators, and ensure alignment with industry standards. A successful Process Engineer will bring strong problem-solving skills, a data-driven mindset, and a proactive approach to identifying and implementing process improvements.

The Scientist II will make an impact by driving raw material second-sourcing projects, including conducting characterization studies and bench builds. Perform characterization studies and analyze organic or inorganic compounds, raw materials, and finished products. Execute bench experiments effectively and develop polymer products and related processes to meet performance specifications.

The Sr. Formulation Technician will be able to perform tasks with little to no direction. They will provide guidance in the absence of the Lead Formulation Technician. They will be proficient in aseptic filling and manufacturing. This colleague follows written and verbal instructions using cGMP documents and operating equipment when performing the following duties. Shift hours are 6am-6pm on a 2-2-3 rotating schedule.

The Scientist I, Manufacturing Sciences, will be responsible for the synthesis of functionalized resins used in columns.

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

This role will support manufacturing production through root cause analysis and implementing engineering solutions. The Engineer will identify and complete improvements to current manufacturing processes. Must uses the latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project timelines and product costs.

Provides line-level management coordination of resources and work schedules for laboratory activities. 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 laboratory staff continues to be developed to keep pace with department goals and growth.

Join Thermo Fisher Scientific as a Large Volume Formulation Tech 2 on our 2nd shift. This position in our Manufacturing division offers a remarkable chance to perform precise techniques and procedures in formulating liquid chemical solutions for reagents, controls, and calibrators. You will work with large volume equipment (1500L – 36000L).

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

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

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

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

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

Vaxcyte is looking for an energetic and talented individual to play a key supporting role in the Formulation Development function. Vaxcyte is focused on the development of protein conjugate vaccines. They would support manufacture of drug products to support analytical and process development groups within the Drug Product Team. In addition, they would also support scientists in the execution of large and complex experimentation as well as routine studies and testing.

As an Associate Scientist II, you will be using state-of-the art technologies to perform bioanalytical testing for emerging pharmaceutical and biopharma companies. At Veloxity, we hire driven and motivated individuals and provide training and career advancement opportunities within our organization.

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

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

Responsible for performing routine and complex testing of in-process samples and final products in accordance with SOPs for product release and validation.

At Versatope Therapeutics you will work alongside other bright, motivated scientists in developing groundbreaking vaccines and therapeutics. We hire amazing people who are intensely curious and continually questioning.

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

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

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

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

Perform Sterility Testing in compliance with applicable Regulations, International Standards following SOPs in cleanroom type environment, perform QA/QC tasks, prep carts.

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