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The QA Specialist will have oversight of and involvement in, GMP compliance for production of Clinical Trial Material (CTM), including work performed by Contract Manufacturing Organizations (CMOs.
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Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries.
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Coordinates periodic CMO Manufacturing meetings preparing minutes and tracking completion of action items. The Director of Manufacturing is the Business lead, Technical Lead and primary contact responsible for managing Acadia’s commercial Drug Product (DP) Contract Manufacturing Organizations (CMO’s), and other third-party suppliers.
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This includes but is not limited to ensuring compliant and timely manufacturing, OTIF shipments, quality compliance and cost management) - be the BMS 'eyes and ears' at the CMO for flawless execution of commercial operations.
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Contribute to CMO Manufacturing oversight via document review, person in plant responsibilities, and troubleshooting when necessary. Experience working with CMOs highly desired; ability to effectively transfer processes to CMO, and to oversee development and manufacturing activities performed at CMO; ability to travel to CMO (some international travel required) to perform person-in-plant oversight activities.
$129,000 - $146,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Working closely with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events.
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This position reports to the Associate Director Quality Product Testing and will oversee compliance of GMP activities for assigned Contract Testing Laboratories (CTL)/Contract Manufacturing Organizations (CMO) as it relates to QC testing of ImmunoGen products.
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The CMO will lead Manufacturing and help steer department leaders across the organization to successfully scale their processes during the ebb and flow of the sales pipeline, supply chain, and labor market.
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We are seeking a Cost Accountant who assists and is primarily responsible for accounting for inventory, inventory costing and project accounting, in connection with the Companys biopharmaceutical manufacturing operations.
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Execute technology transfer to CRO/CMO organizations and Lilly manufacturing sites. Drive the implementation of technical solutions and analytical strategies to enable synthetic chemistry, process engineering, formulation design, and continuous manufacturing.
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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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Work closely with Global Product Quality, External Manufacturing, and Supply Chain to understand forecasts and deadlines to ensure timely CoA/CoT (Certificate of Analysis/Certificate of Testing) generation for Cell Therapy vector products.
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We specialize in executive searches at all levels inR&D, Drug Discovery, Translational Biomarkers, Precision Medicine, Immunotherapy, Companion Diagnostics, Pharmaceutical Manufacturing & Clinical Trials through to commercialization.
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Partners with Technical Development and internal Gilead manufacturing sites for successful technology transfer and validation of new or existing processes/products to the identified CMO(s.
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To meet the stringent needs of biotechnology research and production customers, the company's cell culture sera and bioprocess liquid manufacturing facilities are segregated between animal origin-free cGMP manufacturing and animal component cGMP manufacturing.
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