·  24-year experiences in biotech R&D, cGMP quality operations, and CMC regulatory affairs.

·  Early-phase and late-phase development of multiple biologic products, including Orencia (for rheumatoid arthritis) and Vectibix (for colorectal cancer).

·  World-wide regulatory filings of biological products, including FDA, USDA, EMEA, Health Canada and Chinese SFDA; Pre-approval inspections (PAIs) by the regulatory agencies.

·  Analytical development and validations of various biologic drug substances and drug products.

·  Early phase development of >3 biosimilars and immunotherapeutics.

·  Directing commercial QC/QA operations of three FDA-licensed facilities producing mAb and fusion protein and EIA based biologics.

·  Establishment (start-up to fully functional and passing regulatory inspections) and management of cGMP QC bio-analytical labs.

·  Management of drug substance and drug product release and stability testing, raw material qualifications and release, and of environmental monitoring programs for cGMP biologics facility.

·  Management of technology transfer teams for establishing contract manufacturing and achieving world-wide registrations; led analytical tech transfer sub-teams.

·  Ph.D and postdoctoral trainings in molecular biology, biochemistry, microbiology, and immunology.