Jul 9, 2022
Vice President, Biologics Downstream Process Development
As head of the DSPD department of 100+ scientists and multiple teams at the Shanghai site of WuXi Biologics, responsible for all downstream process development projects for global clients' e...
from Oct 2017
Director Process and Analytical Technology and Cmc
Built the PAT/CMC department and led CMC efforts starting from cell line development to drug product manufacturing and authoring core sections in Module 3 for multiple IND’s (mAb and protei...
Nov 2014 — Sep 2017
2004 — Apr 2008
Managed a group of 5 direct reports (Ph.D. and B.S.) responsible for multiple functions of method development, metrology, and chromatography data system. Lead a cross-functional project team...
from Oct 2004
Manager, Analytical Sciences, Global Quality
2002 — 2004
Director Analytical Development
Consolidated and managed the Analytical Development department of 10 scientists responsible for Formulation, Analytical, Phamacokinetics/Pharmacodynamics Bioanalytical, and Quality Control f...
Nov 2000 — Dec 2002
Developed, improved, validated and oversaw the implementation of protein, antibody, and cell-based assays for the characterization, QC, regulatory release, and stability monitoring of formu...
Jun 1996 — Nov 2000
1992 — 1996
Developed analytical methods for recombinant proteins, monoclonal antibodies and peptides for process optimization and product characterization. Designed amino acid analysis by HPLC for ce...
1990 — 1992
Chief Revenue Officer
U.s. Food and Drug Administration
High Performance Liquid Chromatography
Good Laboratory Practice
Standard Operating Procedure