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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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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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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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This is a unique opportunity for a Part Time Lab Technician to join a collaborative team testing personal care products under cGMP/GLP regulations. Other courses that would be helpful are: Microbiology, Organic Chemistry, Analytical Chemistry, Instrumentation Analysis, Molecular Biology, Cell Biology, Biochemistry.
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Legend Biotech is seeking QA Document Control Specialist as part of the Quality team based in Raritan, NJ. Role Overview The Quality Assurance Document Control Specialist role is an exempt position responsible for supporting the document management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment.
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Familiar with cGMP/GLP regulations, FDA requirements for pharmaceutical API and finished products, impurity identification, structure determination, USP tests for various pharmaceutical products.
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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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Knowledge of MSDS. Direct experience with regulated environments (e.g., cGMP, OSHA, EPA) preferred. Assists with EHS program tasks and activities, including industrial hygiene, biosafety, ergonomics, process safety, environmental compliance, EHS inspections, fire protection, loss control, hazardous waste management and assistance with EHS committees.
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This position contributes significantly to the successful timey manufacture of experimental and cGMP clinical batches in the Pilot Plant through the maintenance and repair of equipment on the shop floor.
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The candidate will be responsible for executing cell culture batches from 50 L to 1000 L volumes engineering and clinical batches in a cGMP environment. Perform cell culture and bioreactor operations at multiple scales.
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General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
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This position will be responsible for providing operational excellence continuous improvement support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will lead continuous improvement initiatives with various site functions to support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements.
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This individual will partner with other functions to support the production of cell therapy products through safe and compliant manufacturing operations according to cGMP requirements. This individual will oversee process engineering, manufacturing support, technology transfer, validation, and cell therapy automation and provide technical and continuous improvement support to ensure robust production, testing, and the timely release of cost-effective, compliant, and high-quality cell therapy products.
$170,000 - $220,000 a yearFull-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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The candidate will be responsible in the purification of L to 0L volumes engineering, clinical and commercial batches in a cGMP environment. This position requires extensive technical expertise in mammalian cell-based purification processes, cGMP manufacturing and compliance for BLA requirements.
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Specialist, QA Operations, is responsible for quality oversight of Cell Therapy Development Operations (CTDO) activities in accordance with BMS policies, standards, procedures, and Global cGMP requirements.
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cgmp job in Raritan, NJ
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