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8 years of GMP quality assurance experience in the pharmaceutical, biologics or health industry as Quality Assurance Manager, Lead, Specialist or similar role; 10 years of GMP quality assurance experience in the pharmaceutical, biologics or health industry as Quality Assurance Manager, Lead, Specialist or similar role;OR.
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The GMP Laboratory Technician will provide support to the GMP Production team through cleaning glassware, and following established safety and GMP regulations. Cambridge Isotope Laboratories, Inc. (CIL) is searching for a GMP Laboratory Technician based onsite in our Tewksbury, MA facility.
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The ideal candidate should have relevant experience in cell therapy process development, technology transfer to GMP manufacturing and GMP principles related to cell therapy, and enjoy fast-paced, collaborative and vibrant startup culture.
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Operate and execute change control process for system deployment and release management of system software across Good Manufacturing Practice (GMP) validated and Non-GMP environments. Develop and maintain GMP/Non-GMP design documentation and diagrams.
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Consistently conduct pre-processing staging to assure that required raw materials are assembled, weighed, and meet specified parameters following strict GMP procedures. Our GMP Production Technicians work in a team-based environment and are responsible for safety, production, maintenance, and product quality.
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HPLC, GMP, GC, wet chemistry, dissolution, titration, viscosity, UPLC, icp ms. HPLC Wet Chemistry GMP Performs microbiological or analytical chemistry examination testing on raw materials, finished products, environmental monitoring (air, water, surface) and stability samples in accordance with approved Standard Operating Procedures (SOPs) or USP methods, where applicable.
$38 - $43 an hourFull-timeExpandUpdated 10 days ago - UpvoteDownvoteShare Job
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Provide technical leadership and subject matter expertise to the Nucleic Acids testing team to ensure the successful execution of all GMP release and stability PCR testing executed in support of Sarepta' s Gene Therapy programs (currently 1 commercial program and 5+ active clinical programs.
$156,000 - $195,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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BS in Biochemistry, molecular / cellular biology or chemistry with a minimum of five years of Quality Control experience in GMP biopharmaceutical or biotechnology industry. This individual will join the Quality Control Bioassay team supporting the GMP manufacturing facilities in Redmond, WA and Seattle, WA. The role is responsible for conducting routine/non-routine testing and analysis of GMP product using methods such as ELISAs, qPCR, and cell-based assays at both Washington state facilities.
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This position will be involved in bioprocess development and GMP production, including lab scale process development; scale up and tech transfer of the process into the GMP suite, and execution of the process under GMP compliant conditions.
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You will be a part of the Analytical Method Development (AMD) and report to the Principal Scientist responsible for development and optimization of analytical methods that will be used for investigative testing, GMP release testing, and stability testing of Aldevron Products (e.g., nucleic acids, lipid nanoparticles.
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The incumbent will provide Automation support to the daily operations, continuous improvement, and projects for the Pilot Plant, Bulk Manufacturing, Filling, Assembly, Packaging, Utilities, Facilities, and other DCS and PLC Automated Equipment and Control Systems on a GMP regulated environment.
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Ensuring that methods are robust and fit-for-purpose as release tests for GMP Quality Control. This includes creating, revising, and finalizing standard operating procedures (SOP), study protocols, study reports, product specifications, and other GMP documents.
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You will have demonstrated experience, leadership, and independence with QC functions associated with the GMP production and testing of cell/gene therapy products or biologics in both clinical and/or commercial settings.
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Demonstrated background in support of GMP Quality management systems, Background in one or more specialties of biotechnology: bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, process development, cell biology, chemical engineering, and/or biochemical engineering.
$80,000 - $81,000 a yearFull-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Thorough knowledge of quality assurance principles, US Food and Drug Administration (USDA/FDA) meat processing regulations and Global Food Safety Initiative (GFSI) and Food Safety Enhancement Program (FSEP) and Good Manufacturing Practices (GMP) standards.
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