Over 15 years experience including FDA (Acting Branch Chief in CDER/OPQ), complex drug delivery, cell/tissue therapy, BioMEMs manufacturing.
Subject matter expert in evaluating facilities, process design, and control strategies to assure quality production of small-molecule and large-molecule products at commercial scale. Specializing in drug-device combination products, first generic and novel inhalation products, emerging technologies and advanced manufacturing techniques (continuous manufacturing, process analytical technology, real-time release testing, novel extended-release formulation, nanomedicine, etc.)
Conducted many on-site pre-approval/surveillance/for-cause inspections and 704(a)(4) Record request review with a wide array of pharmaceutical manufacturers (ranging from major international pharma sites to first time applicants).
Trainer in internal FDA courses/seminars for training CDER SMEs who participates on inspections, ORA field investigators and compliance officers
Demonstrated achievements in developing innovative solutions to facilitate collaborations within multi-disciplinary teams to achieve technical operation goals, e.g., led the development of the CDER/OPQ review templates for manufacturing and facility (CGMP) evaluation for all dosage forms. Ph.D. in Biomedical Engineering with focus on cell/tissue engineering and computational modeling in “Lab on a Chip” systems, Johns Hopkins School of Medicine. Thesis Advisor: Dr. Andre Levchenko.
B.S. in Chemical Engineering (Course 10), MIT. Research Advisors: Dr. Robert Langer and Dr. Daniel I.C. Wang