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Create and execute project plans for process and assay development and support the transfer of processes to cGMP manufacturing and quality control. Offers training to manufacturing and quality control teams during the tech transfer process.
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As the Associate Director of Process Development, the individual will be responsible for creating protocols and methods for the production of various cell and gene therapy products, procuring the necessary equipment and components for cGMP production, making adjustments to the process and reagents to meet cGMP requirements, facilitating technology transfers, and developing assays for product characterization.
$130,000 - $139,000 a yearFull-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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The Keck School of Medicine at USC is seeking a highly motivated individual to join the USC/CHLA Cell Therapy program and cGMP Facility. Demonstrated experience in academic administration and quality management.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Manages, prioritizes and participates in batch record review and release activities including manufacturing, quality control data and responsible for final release of manufactured product.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Working knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs and USP, JP, EP procedures.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Working knowledge of applicable CTP/SOPs, EHS requirements, and application of cGMP/GDPs. Working knowledge of applicable CTP/SOPs, EHS requirements, and application of cGMP/GDPs. Perform environmental monitoring of clean rooms and controlled areas to support qualifications and routine sampling of the facility and critical utilities including WFI, compressed gas, nitrogen.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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2+ years of relevant experience in biotechnology or pharmaceutical industry with emphasis on quality control testing preferred. Perform routine quality control (QC) activities required for final product release and stability monitoring.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Quality Systems (Change Control, Non-Conformances, Requalification, etc), and Process Excellence Methodologies (Six-Sigma, Lean, etc. Perform testing of the entire SDLC, including version/change control and new software rollouts.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Minimum one year experience in a fast-paced FDA regulated, cGMP manufacturing environment and demonstrated consumer goods product knowledge. Monitor, and evaluate all documented test results, and batch adjustments, recommending corrective action or change control as required.
$19.5 an hourExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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B.S. degree in a scientific discipline with 3 years of experiences in a cGMP compliant environment. Performs QC analytical testing to support the release and stability of final products to support the release of products for commercial use, with consideration of compliance, quality, and consistency.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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You will oversee projects which involve radiosynthesis, quality control and packaging of clinical radiotracers. You will produce, test, and package radiopharmaceuticals in a cGMP compliant environment.
$67,400 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Maintains internal quality system documentation, change control, specification, validation systems managing CAPAS and non-conformance to assure compliance to cGMP. Assures systems are in place to appropriately identify, review scope and impact, and disposition process variations and deviations from written standards and procedures.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Bachelor’s Degree and 5+ years’ experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, and/or cell therapy operations. Liaise between support organizations, Microbiology, Quality, Engineering, Validation, Regulatory Affairs, Process Development, etc.
ExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Develops and implements primary quality control systems consistent with GXP (GMP, GLP, GCP) and SOPs. Hires, trains, supervises, motivates, and develops quality control staff; manages schedules and workflow.
ExpandApply NowActive JobUpdated 6 days ago
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