Ken Lewis

About Ken Lewis

Analytical scientist with more than 30 years’ CMC experience with a focus on analytical methods and product quality. Proven leader in a variety of departmental, project, and technical roles. Expert in analytical method development, transfer, and validation for protein, cell, and gene therapy products. Extensive experience with direct client interaction. Excellent verbal and written communication skills. Experience with developing regulatory-CMC strategies and authoring regulatory submissions for early phase (FIH) through commercial products.

Experience

1. Managing Director, Bioprocess Technology Consulting Group

   BDO USA

   Jan 2022 — Present

   Provide analytical development, process development, and other CMC consulting services to biopharmaceutical clients including: due diligence and gap/risk assessments, authoring RFPs and CDMO/CTO selection, CDMO/CTO oversight with a focus on analytical development, method transfer, and QC testing, cell-based potency methods, identification of phase appropriate analytical method panels, implementation strategy and lifecycle planning, analysis of stability data to characterize degradation pathways and establish shelf-life, authoring module 3 regulatory submissions and responses to information requests.

Education

• Davidson College

  B.S. , Chemistry

• University of California, Berkeley

  Ph.D., Chemistry: Surface Science/Catalysis