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Robust scientific background and understanding of CAR-T manufacturing and process development under cGMP processes. Experience supporting autologous cell therapy process development, process scale up, optimization and manufacturing along with process characterization and late-stage development is highly desired.
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As a member of the Technical Development group, this individual will manage and own current and future Cell and Gene development projects and contribute to interdisciplinary technical development work in the larger CGT organization.
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Prefer Operational Excellence experience in a regulated industry such as pharmaceutical, nutraceutical or food processing industries, with familiarity of cGMP and other regulatory requirements.
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Knowledge of current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and regulatory pharmaceutical marketing and manufacturing principles, practices, and their application.
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Resolve observation / CAPAs generated from internal and external cGMP audits related to Validation, Qualification, and Commissioning studies. Understanding of validation principles, current Good Manufacturing Practices (cGMP), and applicable regulatory requirements.
$61,750 - $143,000 a yearFull-timeExpandApply NowActive JobUpdated 1 days ago - UpvoteDownvoteShare Job
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2-4 + years of applicable experience in a clinical laboratory, hematology, blood banking, immunology or cGMP manufacturing. Under the supervision of the Associate Manager, the Manufacturing Associate II processes, cultures, cryopreserves and otherwise manipulates cell products using aseptic techniques, according to written Standard Operating procedures, in accordance to facility GLP, GTP and GMP practices.
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The Quality Assurance Manager will ensure compliance with current Good Manufacturing Practices (cGMP) as they pertain to the local regulation and exporting countries regulation as applicable (such as FDA, MHRA, EMA, Health Canada.
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The Manufacturing Operator/Technician II is responsible for all functions relating to the processing of drug products; consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP.
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At least 2 years warehouse experience in a cGMP environment. Must wear steel-toe shoes/boots, protective eyewear, lab coat and gloves are mandatory when handling open shipments of returned goods.
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Manufacturing operator/technician II are expected to operate any industrial machinery such as Forklifts, Hi-Lo, Reach Truck, Hand truck, Pallet Jack, Drum lifter etc. Operates pharmaceutical production machinery and executes procedures for manufacturing such as dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing etc.
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Maintain cGMP supplies such as hairnets, ear plugs, and beard nets. Maintain cGMP supplies such as hairnets, ear plugs, and beard nets. Communicate with the lead person as to specific job requirements.
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Support cGMP, GFSI, ISO9001, SPC, SQC, and any other Quality and Food Safety and Occupational Safety programs/initiatives. Experience with lab instrumentation such as gas chromatography, NIR, specific gravity, melting point, and wet chemistry techniques.
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The engineer will perform a wide variety of tasks following cGMP which will include the. SkySys specializes in Recruitment & Staffing, 24/7 On-Site & Remote Services, Managed Services Provider (MSP), Value Added Reseller (VAR) partner for Cisco and Dell, Contact Center Solutions (Cisco, Avaya, Genesys), Web Solutions, and other services.
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6+ years relevant experience with tissue manufacturing, gowning, and operation within cGMP environments. Leveraging Celularitys new, state-of-the-art cGMP capable facility, this position will make use of existing innovations and future technologies to meet and exceed manufacturing demand.
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Trained in cGMP requirements, including batch documentation and sanitization Quality oriented resolute Computer skills are required. Maintain a neat and tidy work area at all times Quality - Take full responsibility for the Quality of our product by: Understanding and following all cGMP requirement Following all quality related SOP's, signs, directions, etc.
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cgmp job in Fairfield, NJ
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