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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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Biology, mammalian cell, cell culture, aseptic technique, cryopreservation, thawing, gowning up, gmp, cgmp, upstream, downstream, mammalian, gene therapy. biology, mammalian cell, cell culture, aseptic technique, cryopreservation, thawing, gowning up, gmp, cgmp, upstream, downstream, mammalian, gene therapy.
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Support in equipment troubleshooting, pilot scale material generation, non-GMP tox material generation and GMP downstream manufacturing activities. Execute, with oversight of qualified staff, complex unit operations including but not limited to chromatography, TFF, depth filtration, virus filtration, and buffer preparation in GMP manufacturing suites.
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The Fill/Finish Supervisor's role entails aiding in GMP Fill Finish manufacturing processes by applying extensive knowledge of theories, methods, and principles to address operational and routine tasks in aseptic production of biologic drug products for Phase I/II & commercial GMP manufacturing.
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The Lead BPA is responsible for supporting the overall GMP manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing.
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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.
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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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3+ 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 can execute as skillfully as well as troubleshoot Iovance’s GMP cell therapy manufacturing process(es.
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Experienced in GMP downstream manufacturing; especially with TFF, Chromatography systems and purification of Mabs. Key Experience For Manufacturing Associate, Downstream. Complete relevant paperwork following GDP/GMP guidelines.
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Support large-scale biological production campaigns for GMP by performing: Aseptic inoculation and growth of mammalian cultures of various sizes Operation of bioreactors/fermenters, tangential flow filtration (TFF), centrifugation, chromatography, and ultra-purification processes Cleaning and steam-in-place activities for equipment.
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Experience with Tech transfer to CDMO for non-GMP and GMP manufacturing, including cell line development, process development, analytical method development and manufacturing scale up. Protein Biologics Development experience with proteins refolded from E. coli and proteins expressed in CHO cells with oversight of process development for both upstream and downstream.
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Leading biologics downstream process development to design and conduct studies to deliver high process yield, robust, and scalable processes to support GMP manufacturing of biotherapeutics.
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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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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 Process Engineering Intern will support operations and equipment in both upstream and downstream drug substance manufacturing. The incumbent will provide technical engineering support to help ensure the successful deployment of new equipment, single-use systems, and processes; support and troubleshoot existing equipment for GMP clinical manufacturing processes and be involved with the tech transfer of processes from small/lab scale to large/commercial scale.
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