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Team scope is organized around cell therapy manufacturing unit operations such as media, selection, activation, or harvest which are executed in accordance with Current Good Manufacturing Practices (cGMP's) in both a clinical and commercial setting.
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As the head of Biologics Development, you are responsible for the end-to-end, cell vial to product vial, development of biologics manufacturing processes, which include antibody, conjugation, formulation and drug product.
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Provide QA and CSV expertise within a manufacturing environment, specifically working with MES, DeltaV, and OSI PI systems. Manufacturing experience with a focus on MES, DeltaV, and/or OSI PI.
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Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck's first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes.
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This is a key position that ensures the reliability of equipment for new Bio-Manufacturing Facility as well as maintaining the current operation of the existing facilities. Perform preventative maintenance work on complex manufacturing equipment such as bioreactors, processing pumps, valves, RO/DI water systems, distillation systems, distribution systems, steam generation, compressed air systems and other manufacturing and utility system equipment.
$49.55 an hourFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Knowledge of materials selection, composites, and additive manufacturing techniques. Evaluate materials and manufacturing techniques to optimize structural performance while considering weight, cost, and manufacturability constraints.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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The Senior Manager, Cell Therapy Instrumentation will lead a product management team that is passionate about developing and driving a multi-generation product portfolio strategy to commercialize instrument solutions that support the development and manufacturing of cell therapies.
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Since integrating into Lundbeck in October 2019, Lu-SBP has supported the commercial launch of Lundbeck’s first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes.
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Create and modify PCBA design packages and electrical component specifications, including but not limited to electrical circuit schematics, PCBA manufacturing specification packages, and wire harness / cable assembly specifications for products currently in production phase.
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In partnership with QC, serve as the Subject Matter Expert (SME) in the transfer of analytical methods from Lundbeck to GMP contract labs/contract manufacturing organizations (CMOs) Assist in the preparation of CMC regulatory submissions including authoring and/or review.
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Inform Supervisor/Manufacturing Engineer of problems or issues. Assist Supervisor/Manufacturing Engineering in maintaining and reporting on Daily Management and Build Schedule progress. The Manufacturing Assembly Technician I will work closely with the manufacturing engineering team and will be primarily responsible for manufacturing instruments on an assembly line.
$46,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Ph. D. or M.S. in cell biology, molecular biology, biochemistry or related field with 8+ years of relevant experience (for Ph. D) or 12+ years relevant experience (for M.S) in biologics. Independently develop strategy for potency assays including justification for design of assay and link to mechanism of action (MOA.
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AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, they deliver deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics and cell and gene therapies.
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Strong knowledge of design control, change control, process validation and tech transfer, and in-vitro molecular diagnostic manufacturing. Work scope of this position includes management of key processes relating to quality engineering tasks, ensure robust design controls, supplier quality, risk management, tech transfer to manufacturing operations and driving KPI affecting quality in manufacturing.
$110,000 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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The MES Recipe Engineer and Validation Specialist role will deliver electronic batch record (EBR) configuration and validation in the Client Syncade Manufacturing Execution System. Experience with cell therapy or other biopharmaceutical manufacturing.
Full-timeExpandApply NowActive JobUpdated 5 days ago
manufacturing job Title: senior scientist in Bothell, Peoria, Arizona
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