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Position Responsibilities: Perform cGMP analytical testing (bioassay, flow cytometry, qPCR, ELISA, and UPLC) Review and evaluate raw data from a peer or technical review level of all analytical methods, as well as sample authorization.
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In this critical role you will p erform laboratory work in a cGMP manufacturing setting, primarily working with iPSC cell culture and differentiation, following bio-manufacturing procedures and manufacturing schedules to facilitate on-time delivery of high-quality finished products.
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Routinely provide performance feedback and guidance to employees in addition to conducting formal evaluations and reviews QUALIFICATIONS BS or MS in analytical chemistry, biochemistry, or biotechnology or equivalence BS with 3+ years or MS (0+ years) of professional experience in the vaccine or pharmaceutical industry in the field of QC analytics or R&D. Preferred 2 years of experience in cGLP or cGMP lab.
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Provide hands-on leadership for the QC Sample Management operations; management of daily/weekly/monthly activities of staff and operational oversight of group, data review, schedule, and training.
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CGMP manufacturing experience, cell/gene therapy, with experience in tech transfer, process validation, project management, and change management. We are seeking a highly motivated Senior Director of Cell Therapy Operations who will be responsible for the readiness, launch, ramp-up, and oversight of cGMP Operations within a state-of-the-art multi-product cell therapy manufacturing facility that will be utilized to manufacture autologous and allogeneic cell therapy products.
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Responsibilities include managing QC samples, shipping, and testing logistics, reference standard inventories, and data entry from CTLs/CMOs into Gilead's LIMS. The role will contribute to QC procedures across Gilead's biologics manufacturing network, ensuring global cGMP compliance.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Proven experience as a direct manager of people and as a leader in a cGMP Manufacturing operations of cell therapy products with clear understanding of the required relationships between Manufacturing and the other supporting departments (i.e. Warehouse, Maintenance, QC, QA etc.
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The QC Analytical Scientist’s primary responsibility is to perform routine to complex QC testing pertaining ELISA testing and Cell Based Assays in accordance with cGMP regulations.
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In QC Bioassay we perform a broad range of compendial methods, bioassays (e.g., ELISA’s, protein concentration, and SDS-PAGE), as well as cell-based assays. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan.
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Responsible for supporting the sample management process for QC (pick up from manufacturing, maintaining chain of custody in LIMS, aliquoting/delivering samples to appropriate lab, etc) Individual should have knowledge of current Good Manufacturing Practices (cGMP), Laboratory Information Management System (LIMS), Microsoft Office™ applications specifically Word and Excel, analytical techniques and instrumentation, Lean Six Sigma concepts, and Lean Labs.
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The QC Analyst II will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial small molecule and biosimilar products in cGMP-compliant laboratories.
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The QC Sample Management Consultant position will be responsible for supporting the Quality Control team in the establishment of a robust GMP sample shipment process as well as internal sample tracking/reporting capabilities.
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Bristol-Myers Squibb is seeking a quality control professional to join our QC STAT team, performing QC testing in support of biologics bulk drug substance manufacturing using defined methods in a cGMP compliant laboratory.
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Ensure compliance to all data integrity and cGMP practices, and procedures, and expect. This QC opening performs routine testing using various chemistry techniques. Hplc, sap, Karl Fisher, FRIT, uplc, GC, gas chromatography, raw material, Chemistry, Quality control, Analytical chemistry, Gmp.
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The Senior QC Analyst position interacts regularly with TScans Quality Assurance, Analytical Development, Process Development, Manufacturing, Facilities, as well as TScans external test laboratories, where applicable.
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