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The Senior Research Scientist I, Cell Culture Process Development (Pre-Pivotal) will be responsible for leading aspects of cell culture development including process development and process implementation at internal or external GMP facilities for Gilead biologics entities during pre-pivotal phases development (pre-clinical, phase I/II.
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In-depth understanding of product characterization of biologics, including monoclonal antibodies and proteinsIn-depth technical understanding of early and late-stage development of biologics products, including CMC Regulatory, Process/Analytical Development, and GMP Manufacturing and QC release and stability testing.
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Has hands on experience with monoclonal antibody or antibody-like molecule purification at GMP, pilot and/or laboratory scale. Support transfer processes to GMP manufacturing site for clinical material production.
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Plc programming, Rockwell, Allen-bradley, scada, autocad 2d, hmi programming, equipment validation, project design, project management, gmp, industrial automation, engineering change orders, documentum.
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The Head of PMV oversees an organization of over 100 team members including scientists, engineers and associates responsible for QC microbiology supporting all South San Francisco GMP production operations, adventitious agent testing, process virology R&D and validation, purification processes development and transfer to manufacturing operations from non-clinical studies to the registration stage of biologics.
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Act as Technical System Owner (TSO) for a wide range of automation platforms, control systems and system applications such as BAS, PLC, SCADA, data historian and other GMP & non-GMP automation assets.
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This position provides cross-functional GMP/GCP/GLP compliance support for ongoing and new clinical studies. Experience working effectively with CROs/CSPs. Expe rience with electronic Quality Management Systems and Trial Master File. Skills and Abilities A solid understanding of GCP, GLP, GMPs and CMC requirements is expected.
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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. In-depth knowledge of ICH, FDA, and EU GMP and GLP regulations with all phases of drug development.
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About Insourcing Solutions Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment.
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The Vice Preside of CMC Radiopharmaceutical Process Development will provide oversights to cell line development, antibody process development and scale up, conjugation and radio drug substance and drug product development and GMP manufacturing.
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Working with the firm’s management, in particular the Global Managing Partner (GMP), Regional Managing Partners (RMP), the Chief Operating Officer (COO) and other key stakeholders, the Global DS&E will identify, develop and implement initiatives at the core of the strategic development of the firm.
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Participate in the tech transfer of Master cell bank generation, cell culture and primary recovery processes to the GMP manufacturing facilities in Worcester, MA. The Cell Culture Development Group in South San Francisco, CA is seeking a Scientist I to join a talented and collaborative team to develop cell culture processes for GMP applications.
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Tech transfer to CMO and scale-up of chemistry, including supporting GMP manufacture. Awareness and understanding of ICH, GMP, and regulatory guidances that are important to consider in new drug development.
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Thorough understanding and working experience in drug substance development and manufacturing with respect to GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements.
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Design Controls for regulatory compliance & filing (ISO , etc): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, batch records, etc. Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
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gmp job in South San Francisco, CA
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