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The scientist will also ensure the transfer of robust manufacturing processes to CMO from Bristol Myers Squibb (BMS) Product Development (PD)/ Global Product Development and Supply (GPS) or CMO. The scientist will also ensure robust process performance at CMO during commercial manufacture by use of continuous process verification, Operational Excellence (OPEX) principles, etc.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Partner with Manufacturing, Product Support, Microbiology, Regulatory Affairs, Quality Control Labs, Engineering and Compliance. Utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), and international organization for standardization (ISO.
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The QC Microbiology Data Reviewer is an exempt level position with responsibilities for reviewing microbiology data and documentation generated from the Environmental Monitoring program, drug product and intermediates testing from the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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We are seeking an innovative and highly motivated individual to join us as the Manager, Quality Control Microbiology at our GMP manufacturing facility located in Bridgewater, NJ. You will work with the Quality Control team in supporting our efforts in the GMP manufacturing of cellular therapy products.
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The Quality Engineer II will provide compliance and technical support to Manufacturing on all aspects of the biological manufacturing process controls at the Raritan manufacturing site for the Transfusion Medicine line of business.
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Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant", Technical Transfer teams, Supplier Selection, Serialization Manufacturing and Packaging launch teams.
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Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery.
$21 - $45 an hourFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent. Investigate and/or evaluate manufacturing, packaging and laboratory deviations or incidents and associated Corrective and Preventive Actions (CAPA's) and provide direction and recommendations as to future course(s) of action.
ExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Write, review, and implement SOPs to ensure compliance with current Client standard and current Good Manufacturing Practices (cGMP) Provides Quality and Compliance oversight to Contract Manufacturing and Packaging Organizations (CMOs) within a cross-functional team and Product Disposition functionality for drug products manufactured by CMOs.
ExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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Provides Quality and Compliance oversight to Contract Manufacturing and Packaging Organizations (CMOs) within a cross-functional team and Product Disposition functionality for drug products manufactured by CMOs. Primary responsibility is to ensure that the CMOs are operating in compliance with all.
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Provides Quality and Compliance oversight to Contract Manufacturing and Packaging Organizations (CMOs) within a cross-functional team and Product Disposition functionality for drug products manufactured by CMOs. Primary responsibility is to ensure that the CMOs are operating in compliance with all Client (Client) Co. and applicable Food and Drug Administration (FDA) and international regulatory standards.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Write, review and implement SOP s to ensure compliance with current Company standard and current Good Manufacturing Practices (cGMP). Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control and Archiving (DCA.
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Work for a growing CDMO cell and gene therapy Biotech company that does both product development and manufacturing! Candidates must have experience gowning up, along with EM, bioburden testing, and water and air sampling to be considered for this roleSummary:+ Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU, and other global regulatory requirements at all times.
Full-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Role Overview The QC Microbiology Supervisor, CAR-T Manufacturing is an exempt level position with. Role Overview The QC Microbiology Supervisor, CAR-T Manufacturing is an exempt level position with.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility.
ExpandApply NowActive JobUpdated 7 days ago
microbiology manufacturing jobs in Piscataway, NJ
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