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Transfers and Introduces technology of cell therapy-based and therapeutic protein processes into manufacturing collaborating extensively with Scorpion’s Process Development group to develop cGMP-compliant, clinical-scale production processes.
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Knowledge in purification of vaccines/biologics; Experience in various chromatography methods, filtration, and TFF unit operations at bench scale and pilot scale desired. We are seeking a Scientist to join our Downstream Process Development Department - Process Sciences in Gaithersburg, MD. Qualified individuals will play a role in downstream process development; scale up, new technologies, and technical support of cGMP manufacturing for protein particle vaccines.
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Hands-on experience at laboratory, pilot, or manufacturing scale for biologics products. The successful candidate will apply scientific principles and utilize/Operate Disposable bioreactor systems ranging from 2L to 500L scale, various filtration techniques, and separation technologies to improve current commercial and develop next-generation processes of monoclonal antibodies and recombinant proteins, with responsibilities spanning bench and pilot-scale process development & characterization, as well as the support of technology transfer to manufacturing facilities.
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In-depth knowledge of medium development, bioreactor scale-up principles, scale-down models, tech transfer concepts, and bioreactor engineering. The global Cell Culture Development (CCD) organization within Sanofi operates with the mission to develop robust, scalable and high productivity cell culture processes for Sanofi’s very diverse early and late-stage biologics pipeline.
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In-depth knowledge and deep understanding of mammalian cell-culture processes including molecular biology & cell culture engineering concepts, media design, bioreactor scale-up, mass transfer, bioreactor control, single use and stainless bioreactor systems.
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They will also be a member of the Pivotal/Commercial Biologics Technical Development Leadership Team, that is responsible for providing leadership and decisions on the development and commercialization strategies for all aspects of late-stage process development (Cell Culture, Purification, Drug Product, Analytical Sciences, MSAT, and Materials Sciences.
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The successful candidate excels in a collaborative, cross-functional, matrix team environment to enable the development of new drug products for pharmaceutics, biologics, and emerging modalities such as, but not limited to, antibody-drug conjugates, gene therapy, oligonucleotides, and SiRNA nanoparticulate delivery.
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The individual will play a hand-on execution role in the routine operation of the Biological pilot plant whose purpose is to produce material for preclinical, clinical, and commercial biologics drug substance to support Clients pipelines.
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Process Engineering also partners with Biologics CMC Development and Aesthetics R&D functions to provide active engineering support to enable robust process scale-up and manufacturing of biologics drug substances and drug products, including toxins and cosmetic active ingredients (CAIs.
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Senior Associate Scientist, Cell Culture Process Development - Pre-Pivotal Biologics CMC Development – Foster City, CA. Hands-on laboratory operations experience including shake flask, high-throughput bioreactor, bench scale bioreactor, and pilot scale cultures.
$133,280 - $172,480Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The individual will be responsible for executing and participating in activities supporting the scale-up and system operations for the manufacture of biologics drug substances, ensuring compliance with relevant regulations and GMP guidelines.
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The Biologics Virus Clearance Validation Leader is responsible for cell culture and purification process stretching studies, resin lifetime studies, buffer/solution hold time studies, at-scale membrane and resin lifetime verification studies, virus clearance studies, limit of in-vitro cell age studies, preparation for the regulatory files, PAI and support through the product lifecycle including knowledge management.
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You possess knowledge of biopharmaceutical industry including biologics, viral, or cell therapy process development with scale up for relevant modalities highly encouraged. You have a minimum of 3 years biopharmaceutical industry experience within upstream cell culture development or process development; MSAT, cGMP Manufacturing and/or Tech Transfer experience a plus.
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Associate Scientist, Biologics Process Research & Development page is loaded. Conduct laboratory-scale and/or pilot-scale studies to support scale-up and tech transfer of processes.
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The ideal candidate has a combination of strong academic and industrial research and development background in the formulation of dry microbial products (or other biologics such as enzymes and proteins) including tech transfer and scale-up for applications in food, agriculture, nutraceuticals, biotherapeutics, personal care, or consumer care products.
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