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Knowledge of cGMP Quality Systems including change control, discrepancy management, CAPA, lot release and validation. cGMP Cell Culture or Purification experience required. Manage and oversee cGMP operations at Adverum’s drug substance CMO to ensure manufacture of Adverum products on-time and meeting quality, compliance, and applicable regulatory requirements.
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The Sr. Manager will be responsible for leading all facets of Technology Transfer into manufacturing, GMP floor support and Continued Process Verification in accordance with current good manufacturing processes (cGMP.
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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 role will contribute to refining QC procedures across Gilead's biologics manufacturing network, ensuring compliance with global cGMP and Gilead's Quality Management System. Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Well versed in FDA, EMA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and authored CMC sections in INDs. Working knowledge in lab automation, data science, knowledge management, single-use manufacturing technology and cGMP guideline is a plus.
$221,170 - $286,220Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Responsibilities include supporting outsourced testing coordination, sample management and shipping, reference standard inventories, and data entry from CTLs/CMOs into Gilead’s LIMS. The role is accountable for refining QC procedures across Gilead’s biologics manufacturing network, ensuring global cGMP compliance.
$99,790 - $129,140ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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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.
Full-timeExpandApply NowActive JobUpdated 2 days ago - 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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Ensuring Robust Production: Lead cell therapy manufacturing operations and facility support activities to ensure robust and safe production in compliance with cGMP requirements. Strong knowledge/ understanding of FDA regulations (GMP’s), industry standards, and cGMP Quality systems.
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Possess a strong knowledge of the FDA, cGMP, and GCP standards as well as regulatory guidance documents such as Annex 13. Possess clinical supplies experience/knowledge in forecasting, demand / supply planning , IRT systems, inventory management, clinical labeling and distribution including cold chain, import/export, and reverse logistics.
ExpandApply NowActive JobUpdated 8 days ago - 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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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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Leads end –to-end clinical supply responsibilities including but not limited to protocol interpretation, demand planning, supply planning, distribution, inventory management, label generation and planning and execution of labeling operations at partner contract manufacturing organizations (CMOs.
$74 - $82 an hourExpandUpdated Yesterday - UpvoteDownvoteShare Job
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Solid knowledge base in cGMP and/or GMP Annex 1, with direct experience in managing and executing Cx and validation (e.g., manufacturing facility IOQ, PQ). In this position, you will develop, implement, and oversee capital cGMP projects to support biopharmaceutical research and development, and operations.
$154,020 - $199,320Full-timeExpandApply NowActive JobUpdated Today
cgmp job in San Mateo, CA
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