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Experience working in a cGMP or clean room setting (this job is non-GMP but knowledge of GMP is helpful for process/tech transfer activities). Experience with upstream and/or downstream bioprocessing equipment, especially perfusion technology.
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This person will join a fast-paced, collaborative, and multidisciplinary team to support bioreactor process development (perfusion and intensified fed-batch) at the bench and pilot scale for the advancement of low-cost biotherapeutics manufacturing.
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Aseptic, Sterile Injectables, cGMP, Downstream, Fill finish, Gmp, Cleanroom, Laboratory, Contract Manufacturing, Compound, Compounding, batch processing, Autoclave, pharmaceutical manufacturing, pharmaceutical, gowning, Chemistry, Sop, Batching, Aseptic technique, Quality assurance, Inspection, Sanitization, Batch record.
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Minimum 2+ years of experience in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing. Develop a Subject Matter Expert (SME)-level understanding of and be able to skillfully execute as well as troubleshoot Iovance’s GMP cell therapy manufacturing process(es.
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Demonstrated administrator knowledge of computer systems in the specific area of expertise for example BMS for Utilities, CMMS for GMP Support, specific equipment software for Upstream/Downstream, etc.
$100,000 - $150,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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As a scientist in the Purification Development group, you will identify and develop new purification technologies, work to design optimized downstream drug substance processes for new biologic candidates, employ strategic thinking to overcome technical hurdles and oversee process technical transfer to GMP manufacturing facilities, as they make their way from discovery to the clinic and eventually commercialization.
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The group supports non-GMP transient protein lead production across the companies diverse biotherapeutic discovery portfolio to enable the research units and their pre-clinical therapeutic in-vitro and in-vivo needs.
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We are in search of a proficient and seasoned Manufacturing Manager or Supervisor with expertise in GMP (Good Manufacturing Practice) environments, particularly in overseeing cell culture and downstream processing operations.
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The desired candidate will perform tasks in a GMP laboratory setting involving upstream processes (large scale bioreactors, centrifugation, and filtration) along with downstream processes (chromatography, ultrafiltration, and nanofiltration.
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Drive collaboration, alignment and awareness across Global Quality and GMP related functions (Supply Chain, Regulatory Affairs, CMC, Pharmaceutical Technology) who are either direct or downstream users/consumers of the related QMS Systems.
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Biologist, biology, mammalian cell, cell culture, protein purification, aseptic, cell banking, GMP, cGMP, cell production, upstream, downstream. biologist, biology, mammalian cell, cell culture, protein purification, aseptic, cell banking, GMP, cGMP, cell production, upstream, downstream.
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Fundamental understanding of bioreactors/fermenters and/or downstream purification techniques. The candidate will be responsible for maintaining current records in accordance with GMP guidelines involving the production of monoclonal antibody (mAb.
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Knowledge of upstream/downstream processing, cell culture, or bioreactor operations is highly preferred. Support bioprocessing activities (buffer preparation, upstream, downstream, aseptic fill) in a cGMP cleanroom setting.
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Lead and oversee the downstream request for proposal (RFP) and bid process and prepare detailed scope of work documents for supplier and subcontractor contracts, including recruiting, prequalifying, evaluating, recommending, and selecting subcontractors, and suppliers.
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Key Words: Sales, Biopharmaceutical, distribution, Bioprocess, Upstream, Downstream. Our client is a provider of manufacturing components to the GMP manufacturing marketplace. Key Words: Sales, Biopharmaceutical, distribution, Bioprocess, Upstream, Downstream.
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