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Author process change controls, technical support memos, tech transfer deliverables, and campaign summary reports as relevant to support manufacturing campaigns. Support the development of technology transfer plans and manage transfer from Process Development and into the selected manufacturing site (internal or external) in partnership with Process Development, Analytical Development, Quality, and the Manufacturing Operations.
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This individual will join the Quality Control leadership team supporting the GMP manufacturing facilities in Redmond, WA and Seattle, WA. As the QC Stability and Sample Management Manager, you will be responsible for the daily oversight for the QC stability and sample management operations in support of routine GMP operations at Just-Evotec.
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Our multi-disciplinary team of mechanical, manufacturing, electrical, aerodynamics, thermal, and analytics engineers works together across all phases of development from idea inception, through prototyping, production, and fleet support.
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Author, document, review quality record documentation including NC, RCI, FI and other areas of quality engineering/validation, spreadsheet validation, and equipment qualification. Partner with Manufacturing, Product Support, Microbiology, Regulatory Affairs, Quality Control Labs, Engineering and Compliance.
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Develop and author comprehensive manufacturing work instructions covering fabrication, assembly, testing, integration, and refurbishment processes. Ability to be on feet for portion of work day*Must be a U.S. citizen due to the nature of the workDesired skills include:*Material Resource Planning systems (SAP, Oracle, JDE, CostPoint, Epicor, Job Boss)*Manufacturing Execution Systems (Solumina, Maximo.
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Author and execute study protocols governing bioanalytical studies to support in vivo studies and sample analysis. Pharmaron is a premier contract research organization that offers a broad spectrum of R&D and manufacturing service capabilities throughout the entire drug discovery, preclinical, clinical development and commercialization process.
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Provide front line and independent process development expertise for clinical and commercial drug product manufacturing operations during sterile processing, process characterization, tech transfer, process validation, and on-going commercial manufacturing.
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Author and review relevant sections of regulatory filings, IND/IMPD, BLA, MAA, etc. The successful candidate will play a key role in overseeing internal process development, technology transfer, and external manufacturing to support the Dragonfly development portfolio.
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Support project team lead to author technical reports and analytical Chemistry, Manufacturing and Controls (CMC) sections in regulatory documents. Lead activities at contract manufacturing and testing sites.
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Author stability protocols, interim reports, and reports for stability studies in collaboration with Analytical Development. Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT, and team milestones are achieved.
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Author and illustrate technician instructional content for gas tungsten arc welding, orbital tube welding, CNC tube bending, precision cleaning, high pressure testing, etc. Experience with metallic manufacturing techniques and equipment for processes such as CNC fabrication, welding (orbital tube and TIG), precision cleaning, forming, inspection, etc.
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The purpose of this position is to provide on-site Facilities maintenance and operations support services at the Harley-Davidson Motor Company Tomahawk Somo and Kaphaem manufacturing sites. Author and administer Requests for Proposal; engagement with outside vendors across all construction disciplines; collaborate with internal and external resources to evaluate multiple solution options; and negotiate with vendors to maximize value for Harley-Davidson.
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Acts as single Point of Contact (POC) to drug product teams to provide expertise/knowledge of manufacturing site process capabilities and practices in drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization and visual inspection.
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Responsible Subject Matter Expert and author of CMC sections of regulatory filings utilizing strong knowledge of FDA, EU and ICH requirements. Deep expertise in late-phase/commercial-phase mammalian biologics manufacturing (downstream drug substance and drug product), small molecule and cytotoxics.
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QC, Supplier Quality), you will provide Quality oversight and support to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines at GTMF and/or contract manufacturing organizations (CMO.
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