Chair, Biologics Monographs 3–Complex Biologics & Vaccines Expert Committee
Career Highlights:
- Sanofi: Director-Principal Scientist, Global Analytical Experts Group; Director-Principal Scientist, Manufacturing Technology; Director, Analytical Methods Validation & Assay Development
- Bayer Biologics: Manager, Analytical Development
Education:
- University of California, Santa Barbara, Ph.D., Cell Biology
- University of Hawai’i, M.S., Botany
- University of California, Berkeley, B.A., Biological Sciences; B.A., Botany
Awards, Recognition, Admissions:
- Chair: USP Expert Committee Biologics-3 Complex Biologics and Vaccines
- Member: USP Expert Committee General Chapters Biological Analysis
- Member: USP Expert Committee General Chapters Biologics and Biotechnology 2
- Board Membership: PDA Biopharmaceutical Advisory Board
- Co-Chair PDA Task Force: Analytical Development and Qualification
- Bourse Chateaubriand Scholarship for Ph.D. research cosponsored by CNRS (Centre National de la Recherche Scientifique) and Elf Aquitaine
- California Sea Grant
A Few Favorite Professional Achievements:
- USP General Chapters for Vaccines: <1238>, <1238> and <1239>
- USP General Chapters for testing and analysis: <198> and <1430.1>
- PDA Technical Reports: TR57-1, Analytical Method Validation and Transfer of Biotechnology Products and TR57-2, Analytical Method Development and Qualification for Biotechnology Products
- 1996 study published in Science 272 on structural characterization oligosaccharides of Arabidopsis thaliana cell wall mutant and their significance to the oligosaccharin theory.
