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Here's What You'll Do:Lead right-first-time cGMP manufacturing of cell and gene therapy products including but not limited to aseptic processing, cell isolation, selection, culturing, cryopreservation, upstream processing, downstream processing, aseptic fill finish and final product visual inspection.
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Duties include processing in upstream and downstream operations while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which apply.
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About you:Commissioning, PIDs, biotech, cGMP, ISA data sheets, valve sizing, pump sizing, single-use, CIP/SIP, URS, FS/FDS/FRS, communication, organization, problem solving, hands-on, self-motivated.
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We are seeking a senior CMC leader with experience to advance our TCR bispecific therapies from lead candidate to clinical development, including internal upstream and downstream development of robust manufacturing processes as well as tech transfer and oversight of cGMP manufacturing at external contract development and manufacturing organizations (CDMOs.
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High level of downstream experience formulating a wide range of products such as creams, lotions, solutions, serums, mousses, surfactant systems, and aerosols. Familiar with GLP, cGMP, and QA/QC personal care industry best practices.
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Train and transfer testing and optimization of downstream oligonucleotide processing including chromatographic purification methods to new or existing team member. Have previous knowledge or willing to learn oligonucleotide process development (cGMP.
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Demonstrated knowledge of cGMP manufacturing with knowledge in manufacturing operations in downstream processing utilizing single use technology (SUT). Demonstrated knowledge of cGMP manufacturing with knowledge in manufacturing operations in downstream processing utilizing single use technology (SUT.
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Support tech transfer to third party manufacturing facilities for scale-up and production, including identifying and generating appropriate product specifications. Experience in leading or assisting in tech transfer, scale-up, and full-scale production batches.
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Provide technical support for engineering and cGMP manufacturing campaigns (e.g. batch record review, change control management, deviation investigation, etc) in collaboration with other line functions (e.g., Manufacturing Sciences & Technology), as needed.
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Lead right-first-time cGMP manufacturing of cell and gene therapy products including but not limited to aseptic processing, cell isolation, selection, culturing, cryopreservation, upstream processing, downstream processing, aseptic fill finish and final product visual inspection.
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You'll collaborate closely with our Process Liquids Solutions Technical Sales Executives (TSEs) to identify and cultivate opportunities for custom cGMP process liquids manufacturing services, aimed at simplifying bioprocess workflows both upstream and downstream.
$120,000 a yearRemoteExpandUpdated 4 days ago - UpvoteDownvoteShare Job
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The product engine, supported by foundational IP, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale.
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