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Oversee all manufacturing activities to ensure compliance with GMP regulations, FDA guidelines, and industry standards specific to cell and gene therapy. In-depth knowledge of GMP regulations, FDA/EMA guidelines, and industry best practices specific to cell and gene therapy manufacturing.
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Strong knowledge of general food safety programs and policies, to include government regulations, OSHA, FDA, USDA, AIB, HACCP, GMP, TTB and Allergen Program. Provide daily monitoring of facility and personnel to ensure compliance to the food safety system of the facility; perform formal audit on GMP.
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Support or lead new process or technology transfer from internal and external partners into GMP manufacturing department including documenting tech transfer progress and authoring technical reports.
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Regulatory Affairs, CMC, IND, IMPD/CTA, NDA, MAA, GMP. Solid knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed product regulatory issues.
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Mechanical aptitude, production, machine operation, production line, production environment, blending, mixing, blender, manufacturing environment, food industry, picking, batch record, compound, fermentation, gmp, food production, compounding, batching, food manufacturing.
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Education and ExperienceBS/MS or PhD in scientific related field10+ years of experience in Radiopharmaceutical or injectable GMP manufacturing environment. The Director of Production will set vision and drive a culture of compliance and teamwork in a GMP radiopharmaceutical environment.
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HACCP procedures, Good Manufacturing Practices (GMP), Integrated Pest Management (IPM) The company's portfolio includes beloved brands such as Honey Bunches of Oats, PEBBLES, Grape-Nuts and Malt-O-Meal cereal, and Peter Pan peanut butter, as well as Rachael Ray Nutrish, Kibbles 'n Bits and 9Lives dog and cat food.
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GMP Manufacturing Associate Day Shift Kelly Science is looking for a GMP Manufacturing Associate to join a leading biopharmaceutical company in Oklahoma City, OK. Job Responsibilities: Execute and monitor GMP manufacturing processes for cell culture-based production, ensuring compliance with protocols and regulations.
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Resilience.com Position Summary: We seek an experienced Analyst, QC Bioassay / Biochemistry to support establishing new commercial-level in-house GMP testing laboratories performing release and stability testing for multiple stages of our gene therapy and immune oncology products.
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Analytical Chemist" , Chromatography , HPLC ,MDI , "Metered Dose Inhaler" , DPI , "Dry Powder Inhaler" ,GMP , "Good Manufacturing Practice. Experience working in a GMP testing laboratory, and/or familiarity with relevant external guidance documents and cGXPs in support of analytical testing.
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Establish and monitor overall plant performance for production and quality standards including compliance with established HACCP, SQF, and GMP guidelines. This position reports to the Chief Executive Officer of Jelly Belly and Ferrara's Chief Manufacturing Officer.
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Hands-on experience in upstream processes and downstream development and manufacturing of biologics (mAbs, fusion proteins) in a GMP environment. The ideal candidate will have extensive hands-on experience in cell line optimization, upstream and downstream development, GMP DS manufacturing, process characterization, validation preparation and PPQ campaigns.
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Develop/support GCP inspectional readiness plans and lead inspectional readiness activitiesHost and/or assist with management of GCP-related inspectionsPartner with GMP Quality and Clinical Operations teams to facilitate the investigation of clinical supply quality issues such as temperature excursions, product complaints and deviations reported from clinical sites.
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Knowledge of HACCP, GMP, FSMA, GFSI (preferably SQF), Food security, Food fraud, Allergens, and other essential food safety programs. Fulfill role as SQF Practitioner (both food safety and quality), HACCP coordinator, and PCQI in compliance with FDA Food Safety Modernization Act.
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In-depth knowledge of USDA regulations, including GMP, SSOP, HACCP, and labeling. GMP Guru: Daily monitoring of plant GMPs (Good Manufacturing Practices) and other essential prerequisite programs to maintain top-notch quality.
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