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Strengthen internal cell therapy CMC capability by work with internal stakeholders and external partners to evaluate and enable cell therapy related GTP/GMP facility, along with delivering clinical material for cell therapy trials.
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This position provides cross-functional GMP/GCP/GLP compliance support for ongoing and new clinical studies. Participates in clinical programs and coordinates the cQA interface with Contract Clinical Research Organizations (CROs), Contract Service Providers (CSPs), Bioanalytical Labs and Investigator Sites.
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In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material.
$111,000 - $136,000 a yearExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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This role will report to the head of Analytical Development and will be responsible for developing, qualifying, and performing Liquid Chromatography-Mass Spectrometry (LC-MS) based methods to be used for characterization and/or GMP quality control of therapeutic proteins in all clinical stages (from early to pre-BLA.
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Responsible for supporting and maintaining the GMP clinical/commercial manufacturing and facility process equipment, Pilot Plant and QC laboratory equipment. The GMP Lead Maintenance Technician: A motivated self-starter with prominent levels of initiative.
$31 - $42 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Partner with GMP Quality and Clinical Operations teams to facilitate the investigation of clinical supply quality issues such as temperature excursions, product complaints and deviations reported from clinical sites.
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The successful candidate will be responsible for the development of scale-able and robust downstream ADC processes and support technology transfer efforts, leading to clinical GMP manufacturing of ADCs.
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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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Creativity and flexibility in problem solving; work collaboratively as part of a teamKnowledge of GMP batch record development, review, and approval processesWorking knowledge of regulations relating to clinical labeling, packaging and distribution activities.
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Review and approve GMP documents (e.g., production batch records, clinical labelling records, lab batches, API and raw material specification, drug product specifications, analytical work order reports, standard test methods, standard operating procedures, protocols for method validation, method validation reports, stability protocols and stability reports, equipment IQ, OQ, PQ qualification protocols and reports, and equipment calibration documentation.
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Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Knowledge of GMP and regulatory requirements applicable to cell and gene therapy drug products.
$130,000 - $160,000 a yearExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Key functions outside CMC include Quality, Regulatory, Clinical, Safety, Corporate Program Management, Project Team Leaders, Toxicology, DMPK, Preclinical functions, Budgeting and Forecasting, IP, and others as organization evolves.
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Manage tech transfer, process familiarization, process development, GMP preparation and manufacturing activities of CDMOs∯*∯ Generate, review, and/or approve study protocols, development reports, and manufacturing batch records.
$205,000 - $225,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Experience in an GMP environment. Technical expertise in Multi-Color Flow Cytometry and ability to perform minor troubleshooting. Maintain flow cytometry and cell sorting instruments as the subject matter expert, including regular preventative maintenance, qualification, software update, data backup, SOP development, and staff training.
Full-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Technical expertise in Multi-Color Flow Cytometry and ability to troubleshoot. We are seeking an Analytical Development, Senior Scientist to join our Technical Operations team in Berkeley. This role will report to the Director of Analytical Development and will be primarily on-site at our facility in Berkeley, CA.
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gmp clinical jobs in Emeryville, CA
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