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AA or BA/BS in a technical field (biotechnology, chemical engineering, bioengineering, microbiology, biochemistry) or equivalent experience, and experience working in a cGMP industrial setting. Our ideal candidate brings previous experience in a cGMP bioprocess or biotechnology setting, and enjoys working with precision in a fast-paced, changing environment, while bringing attention to detail, collaboration, passion, and dedication to their work.
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You have a minimum of 3 years biopharmaceutical industry experience within upstream cell culture development or process development; MSAT, cGMP Manufacturing and/or Tech Transfer experience a plus.
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GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines.
$115,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Recent experience in a clinical laboratory setting that handle cell therapy products using aseptic technique, knowledge of cGMP, cGTP and cell therapy product processing and cryopreservation. Under the direction of the Pediatric Cellular Therapy Laboratory (PCTL) Senior Supervisor, the Clinical Lab Scientist Supervisor has leadership responsibility and appropriate authority for administrative and fiscal functions as assigned.
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Ensure batch records are filled out accurately and completely according to cGMP guidelines. Maintain records to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and SOPs.
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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. Support our software team in developing a robust end-user solution for cell therapy manufacturing that integrations with external manufacturing process and data management software including eBR, MES, QMS, ERP, and LIMS.
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The company focuses on producing cell culture products, instruments, and solutions that help customers streamline their discovery, development, and production processes, and by making custom cGMP bioprocess liquids that radically simplify customers' manufacturing workflows - regardless of batch size.
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How to apply your experience in bioprocess & cell culture to the production of next-generation seafood utilizing cGMP practices. We were founded in 2016 by Aryé Elfenbein, a cardiologist and molecular biologist, and Justin Kolbeck (CEO), a former US diplomat who served in Pakistan and Afghanistan, in an effort to solve one of the world's biggest problems: how to feed a growing population without stripping the earth of its natural resources and biodiversity.
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Expert knowledge of cGMP compliance, ICH guidelines, compendial standards, and HA regulations pertaining to pharmaceutical manufacturing, method validations, product specifications, stability programs and other QC/AD activities.
$178,000 - $218,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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In meeting these goals, the Drug Product Director will ensure that the facilities are maintained in a cGMP-compliant state. Provides leadership in ensuring that all GMP raw materials and supplies are compliant with cGMP.
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Ensure all development work is fully captured intechnical reports, tech transfer and cGMP production records with process development andcharacterization conducted consistent with QbD principles, risk assessments as needed, andprocess validation as appropriate and in compliance with regulatory expectations.
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5+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy. 5+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy.
$90,000 - $210,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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At least 10+ years of experience pharmaceutical or biotechnology industry cGMP experience with 4+ years of relevant experience in GMP Quality Assurance. At least 10+ years of experience pharmaceutical or biotechnology industry cGMP experience with 4+ years of relevant experience in GMP Quality Assurance.
$100 - $130 an hourPart-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Understanding of cGMP quality and regulatory requirements for CMC biologics is preferred. Good understanding of biophysiucal characterization and analytical methods for biologics development: e.g., DLS, SEC, CE, cIEF, ELISA, LC-MS, Peptide Mapping.
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In addition, our team also works on projects with clients to manage these Quality business processes for supply chain, manufacturing, commercial operations and R&D. This includes analyzing various cGMP and 21 CFR Part 11 regulations in the Regulatory Compliance area to determine impact on risk exposure.
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cgmp job in Brisbane, CA
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