Bio

I held leadership positions developing therapeutic biological products at Allergan, AnaptysBio, Becton Dickinson, and Catalent Biopharma Solutions. As a subject matter expert in Biologics CMC, I was often invited to teach training seminars in the international conferences (with rave review). I served as an executive director in CMC and Manufacturing at AnaptysBio in San Diego, successfully driving several therapeutic biological drugs from preclinical to late stage development. I have more than 25 years’ working experience in biologics drug development with a focus on CMC management, technical operations, and regulatory compliance. As a PhD biochemist by training, I use my extensive scientific and technical knowledge, leadership experience, and proven track record in CMC regulatory strategy to support drug development, manufacturing operations and control strategies for clinical trials and commercial use, ultimately assisting in getting more successful treatments to patients. The upcoming 2022 training seminar: The 14th Annual Bioprocessing Summit, Aug 15-18, 2022, Boston, MA. 2-Day Training Seminar TS5 (Aug 17-18): Introduction to Chemistry Manufacturing and Controls (CMC) of Biotechnology Products, Instructor: Kevin Zen PhD https://www.bioprocessingsummit.com/training-seminars The upcoming 2023 training seminar: The 22th Annual Peptalk, Jan 16-20, 2023, San Diego, CA. 2-Day Training Seminar: Introduction to CMC for Biotech Cell & Gene Therapy Products, Instructor: Kevin Zen PhD The 2020 training seminar received rave reviews from scientists, directors, and vice president: The 19th Annual PepTalk, Jan 20-24, 2020, San Diego, CA. 2-Day Training Seminar TS7C (Jan 23-24) – Introduction to Analytical Characterization and Method Validation for Protein Therapeutic Drugs, Instructor: Kevin Zen PhD https://www.chi-peptalk.com/20/training-seminars