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Develop RNA purification, characterization, and analytical methods to generate therapeutic grade material for in vitro and in vivo studies. The ABC site, based in Worcester, MA, offers a unique setting where GM, Biologics drug discovery, development and manufacturing coexist in one location.
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Biologics process development experience, particularly designing and scaling up of bioreactor and purification processes for protein therapeutics. 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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Support of pilot scale operations (up to 500L product bioreactor and corresponding downstream purification process) including upstream mammalian cell culture, downstream purification steps, and buffer preparation operations for production of biologics.
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Experienced Senior Process Development Associate will be responsible for independently executing bench-scale experiments to develop, characterize, and optimize manufacturing processes involving production of protein biologics and plasmid DNA. The Senior Associate will work with scientists, engineers, operators, and other associated groups to optimize, implement, and tech transfer new processes and to troubleshoot any process-related problems.
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As a Senior Manufacturing Associate you will produce research and clinical grade components and products by setting up, cleaning, operating, and maintaining equipment; performing wet chemistry reactions; utilizing pilot grade purification systems, authoring and implementing SOPs, and documenting actions in batch records.
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The Head of PMV oversees an organization of over 100team 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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The R&D Manufacturing Associate will gain experience in various protein purification unit operations for manufacture of drug biologics. The R&D Pilot Plant group primarily focuses on process scale-up and production of drug biologics at the 20L to 1000L scale for use in clinical trials.
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Extensive knowledge of fermentation, standard recovery, purification processes, and related analytics for protein products. Bachelor's, Master's, or Ph. D. in Molecular Biology, Biochemistry, Biological Sciences, Bioengineering, Chemical Engineering, Chemistry, or related scientific discipline.
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Experience with lipid nanoparticle formulation and purification processes, or experience with process development, engineering and manufacturing of biologics drug product processes are highly desired.
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LOTTE BIOLOGICS entered the biologics CDMO business after acquiring Bristol Myers Squibb’s Syracuse biologics drug substance manufacturing site, as of January 1, 2023! The primary role of the Bioprocess Associate I is working on assignments that train for proficiency in the operation of primary production equipment within Manufacturing Operations (Inoculum, Cell Culture and Purification) including adherence to detailed procedures and batch records ensuring compliance with cGMP and safety requirements.
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Oversight of purification development, QC microbiology, and Process Virology sub-functions. Create a strategic direction for Purification process technology development and data management, meeting the future needs of both Technical Development and clinical and commercial customers.
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Execute and monitor critical processes for mAb manufacture such as media and buffer preparation, upstream expression, downstream purification, formulation, fill/finish, and/or secondary packaging.
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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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6+ years cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, and bulk formulation. 6+ years cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, and bulk formulation.
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0-2+ years cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish.
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