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Experience with management of contract analytical work in CAR T or other ex-vivo cell therapeutic discipline and/or lenti-viral vector, including analytical method development, technology transfer, and validation.
$170,000 - $205,000 a yearFull-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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The candidate will play a key role in bringing a wide variety of high-quality clinical and licensed drug products to patients through demonstrated excellence in aseptic processing, technology transfer, process characterization, process validation and continuous process verification.
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This involves the startup of a new commercial manufacturing site, technology transfer, and process validation. Fundamental understanding and application of technology transfer and validation processes.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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It is the division's leader in sterile product and process development, responsible for late-stage commercialization activities including process scale up, technology transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The candidate is expected to proficiently manage manufacturing aspects of commercial support of biologics drug substance process throughout the product life cycle: from technology transfer, process validation to commercial manufacturing, and process improvement in order to meet the financial, quality and throughput objectives.
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Identify candidate sensor technology and candidate endpoints to reflect functional concept, create a plan for human studies (Verification/Pilot, Validation/CES, Interventional trials), including assembling a Digital Biomarker team.
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Apply a fundamental understanding of Upstream (Cell Culture) bioprocessing to support biologics technology transfer, process validation, and plant start-up. + Understanding of process scale-up, technology transfer, troubleshooting, and complex investigation.
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The CES Ops portfolio is dynamic in nature; study types include, but are not limited to, less complex data transfer agreements, retrospective sample/data acquisition studies to more complex prospective studies including sample/data acquisition, biomarker/technology/method validation, genotypic/phenotypic call back studies, and challenge/screening studies.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Strong understanding of QMS business processes, Manufacturing, Development Technology Transfer process, Computer System Validation. Additional Experience in the following would be preferred but not required: o Veeva Vault Quality, Trackwise, Veeva Quality Docs, Kneat Validation Execution, Metric Stream, Process PLM in Manufacturing and Qualityo Manufacturing Execution System (MES) or manufacturing systems integrations i.
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Job Title: Renewable Energy Automation Engineer, BESSDepartment: Systems EngineeringReports directly to: Renewable Energy Engineer – Technology Dept. FLSA Status – Exempt Nidec Industrial Solutions:Nidec Industrial Solutions [NIS] is a $400M Business Unit of Nidec Corporation, a $13 Billion global company focused on motors, drives, and controls.
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Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement. Author and develop SOP and VMP for computer system validation for manufacturing equipment.
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Manage the overall schedule development and integration, including engineering and design deliverables, procurement tasks, and construction management tasks, integrated with IT-automation tasks, commissioning and qualification, operational readiness, process validation and technology transfer.
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Knowledge of biologics regulatory guidelines including FDA/ICH on risk management, technology transfer and process validation. Strong background and subject matter expertise in purification unit operations including column chromatography, filtration (UF, DF, TFF), harvest and viral clearance validation in the manufacture of recombinant proteins and antibodies.
$160,000 - $200,000 a yearExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Experience in sterile pharmaceutical microbiology lab testing including validation, technology transfer, change control. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made.
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Experience in technical support of commercial products, program management, technology transfer to commercial manufacturing sites (internal and to external CMO), process validation and BLA/MAA preparation, PAI support for biopharmaceuticals, technical support of product lifecycle activities (i.e., CPV, PPR, Change and Deviation Management), and knowledge management.
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