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6+ years cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, and bulk formulation. Coordinate daily operations and lead on the floor manufacturing employees to complete production activities safely and compliantly in accordance with OSHA and cGMP guidelines.
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0-2+ years cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish.
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M.Sc. degree in analytical chemistry, biochemistry, or other related fields with minimum of 10 (Sr. Sci I) or 12+ years (Sr. Sci II) of relevant experience (or equivalent combination of education and experience, e.g., B.S. degree and 12 years of experience) working in current Good Manufacturing Practice (cGMP) facilities engaged in the manufacturer and/or quality control of pharmaceuticals and/or dietary supplements.
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PBF is a one-of-a-kind cGMP-compliant pharmaceutical manufacturing facility engaging in next-generation development for cutting-edge companies and government agencies. Our core practice areas include vaccine research, development, and production; microbiology and infectious disease research; biodefense; clinical research; global health security; and HIV/AIDS programs.
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Sr. Scientist I/II : M.Sc. degree in analytical chemistry, biochemistry, or other related fields with minimum of 10 (Sr. Sci I) or 12+ years (Sr. Sci II) of relevant experience (or equivalent combination of education and experience, e.g., B.S. degree and 12 years of experience) working in current Good Manufacturing Practice (cGMP) facilities engaged in the manufacturer and/or quality control of pharmaceuticals and/or dietary supplements.
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Conduct clinical research studies involving administration of investigational products according to the principles of current Good Clinical Practices (cGCP), Good Laboratory Practices (cGLP), and Good Manufacturing Practices (cGMP) and in accordance with all relevant host nation, US Federal, Department of Defense (DoD) and Army regulations and policies.
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Performs cell culture operations safely and compliantly in accordance with OSHA and cGMP guidelines. Utilize standard operating procedures and documents cGMP activities within batch records and logbooks applying good cGMP documentation and data integrity practices.
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Demonstrated experience supporting technology transfers, cGMP manufacturing operations and CMC regulatory submissions and inspections required. Understanding of cGMP, ICH, USP guidance and standards and FDA/EMA regulations relating to CMC and manufacturing for medical devices and combination products.
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You will use your training and knowledge of biopharmaceutical manufacturing to execute operations in a cGMP Facility. Complete setup, use, and cleaning (as necessary) of cGMP production equipment.
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Knowledge of aseptic technique, cGMP, cGLP, or FDA regulations a plus. We seek a Quality Control (QC) EM Specialist to support the Pilot Bioproduction Facility (PBF) at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland.
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The role requires knowledge and experience of scientific concepts, practices, and procedures within the biopharmaceutical field and a cGMP environment. 1-3 years of relevant experience working in a Quality Control work environment, preferably in the pharmaceutical industry with knowledge of cGMP is a plus.
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To be based at HJF in Bethesda, Maryland, and Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland, supporting clinical research activities conducted by the WRAIR Military HIV Research Program (MHRP), the Emerging Infectious Disease Branch (EID), and other affiliated programs.
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Write and revise cGMP documents related to technology transfer and production and materials management (SOP’s, MBR’s, DR’s, etc.,) Maintenance of cGMP manufacturing facility, including equipment and manufacturing rooms.
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Scientist IV: M.Sc. degree in analytical chemistry, biochemistry, or other related fields with minimum of 8 - 10 years of relevant experience (or equivalent combination of education and experience, e.g., B.S. degree and 10 years of experience) working in current Good Manufacturing Practice (cGMP) facilities engaged in the manufacturer and/or quality control of pharmaceuticals and/or dietary supplements.
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Establish and publish Key Performance Indicators (KPI) to track cGMP compliance for stability studies and sample management. Provide hands-on leadership for the QC Sample Management operations; management of daily/weekly/monthly activities of staff and operational oversight of group, data review, schedule, and training.
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cgmp job in Bethesda, MD
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