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It is preferable that the candidate has experience working in a cGMP manufacturing facility, quality assurance, manufacturing compliance, clinical quality, or cell therapy. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
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CGMP manufacturing experience, preferably cell/gene therapy, with experience in tech transfer, process validation, project management, and change management. We are seeking a highly motivated Executive Director of Operations who will be responsible for the launch, ramp-up, and oversight of cGMP Operations within a state-of-the-art multi-product cell therapy manufacturing facility that will be utilized to manufacture autologous and allogeneic cell therapy products.
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This position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. Technical knowledge in metrology, calibrations, instrumentation, automation PLCs, VFDs and electrical practices generally attained through hands-on experience, cGMP compliance, EHS and regulatory standards (e.g. EPA, OSHA and DEA.
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Reporting directly to the Senior Manager of Quality, this position collaborates closely with External Manufacturing Organizations (EMO), spanning pharmaceuticals, medical devices/combination products, consumer products/OTC, and biologics sectors, ensuring adherence to cGMP regulations and Bausch Health requirements.
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Familiarity with the guidelines and regulations of FDA, OSHA, ISO and cGMP is preferred. A bachelor's degree in Medical Technology/Medical Laboratory Scientist, Biology. Medical Technologist Specialist needs 1-3 years' experience with QC, GMP, and immunohematology procedure.
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Safety and Quality Focus: Perform tasks with unwavering commitment to safety policies, quality systems, and cGMP requirements. Our state-of-the-art facility complies with current Good Manufacturing Practice (cGMP) standards, ensuring our products' highest quality and safety.
$49,088 - $66,413 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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A minimum of 5+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy. A minimum of 5+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy.
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The candidate will be expected to organize work to ensure efficient utilization of time and materials and to complete all procedures in a cGMP compliant manner. Ability to work under cGMP guidelines, and coordinate/implement production schedule is necessary.
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The ideal candidate will have experience working within the lab as well as tech transfer within a cGMP environment and be comfortable going into a clean room environment to observe and gather data.
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Train personnel in manufacturing process/operations following standard operating procedures and cGMP guidelines. Responsible for cGMP compliance, ensuring that all production equipment is properly validated and procedures are maintained within validated state.
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Own the coordination and execution of all clinical supply related activities including supply planning, cGMP secondary packaging/labelling, distribution, and logistics for R&D clinical programs.
$120,000 - $155,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Packing Operator is responsible for safely operating the package equipment to package in-process products in accordance with Packaging batch record while following SOPs and Maintaining 100% cGMP & compliance during operations.
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Ability to provide guidance and direction to teams to ensure compliance to regulatory (e.g., cGMP, QSR, EU Directives, ISO standards, etc.) Medical Device, Biopharmaceutical, Pharmaceutical or other highly regulated industry (BLA, PMA, 510K or equivalent) experience is required.
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To ensure product quality, this role much adhere to standard procedures and cGMP (Current Good Manufacturing Practices). Adheres to standard operating procedures and cGMP. The Manufacturing Technician is responsible for the aseptic manufacturing of tissue-based (human and porcine) products for the regenerative market.
$20 - $24 an hourExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Maintains the work area in a neat and orderly fashion at all times and complies with cGMP s and Good Housekeeping Practices. Must be able to operate a fork truck and willing to participate in the safety drug screening program.
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cgmp job in Branchburg, NJ
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