Over 25 years of experience working with established and start up biopharmaceutical companies including Amgen, Eli Lilly, and Coherus Biosciences. He has a diverse background working with microbial, mammalian, and cell therapy/T-cell modalities. He earned his B.S. in Chemical Engineering from the University of Missouri. He has supported processes in both clinical and commercial phases, providing process development and characterization, technology transfer, protocol development, technical support, process improvement, and QA/QC systems support.

 

• Expertise with equipment including specification, design, commissioning and testing.

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• Quality Engineer approving IOQ protocols and post testing review and approval.

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• CMO project management collaborating with cross-functional partners including, Quality, Manufacturing, Process Sciences, and Supply chain, to develop processes and systems that enable compliant, successful technology transfers, operation and lifecycle management of cGMP clinical and commercial manufacturing processes, ensuring product delivery schedules are met.

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• Work in a process development role providing lab scale testing, analytical support and assessment, and process characterization.

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• QA/ MFG SME representing clients at CMO sites providing tech transfer and manufacturing oversight.

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• Senior QC Project Manager driving QC workstreams and backlog at CMO Sites.

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• Manage pilot plant production of tox material and technology transfer to the clinical site.

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• Project Leader coordinating project planning, resourcing, staffing, progress reporting, people management, and troubleshooting for plant projects ensuring project results meet requirements regarding technical quality, reliability, schedule and cost.

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• Technical transfer leader with Internal and External Manufacturing partners and CMO’s to assure product manufactured is delivered on time for supply, and all quality and compliance related matters meet appropriate cGMP and regulatory requirements.