Curriculum Vitae
Education
1990 Ph.D. Worcester Polytechnic Institute, Biochemical Engineering, Massachusetts, USA
1987 MS Worcester Polytechnic Institute, Chemical Engineering
1979 MS KAIST, Chemical Engineering, Seoul, S. Korea
1977 BS Yonsei University, Chemical Engineering, Seoul, S. Korea
Professional Experience
2023 ~ Present
Korea Health Industry Development Institute (KHIDI), Executive Consultant
- CMC-related Regulatory Strategy
- CMC Development (Product Manufacturing and Quality Control)
- FDA Meeting Preparations (INTERACT, Pre-IND, EOP2, Pre-BLA, etc.)
- IND, Amendments, BLA Preparions
- GMP Compliance and Facility Audits
2020 ~ 2023
ILIAS Biologics, CTO/Advisor, Led the exosome product development, which is currently conducting clinical trials in Australia
2017 ~ 2019
Helixmith, SVP, Led the RA and CMC for gene therapy product development
2006 ~ 2017
U.S. FDA CMC reviewer, Maryland, USA
- Reviews monoclonal antibodies, fusion proteins, ADCs, and biosimilar products and performs GMP facility inspections
1999 ~ 2006
Worked at a laboratory affiliated with the U.S. Department of Defense at Maryland, USA
1989 ~ 1999
Alpha-Beta Technology (USA) Group Leader, Massachusetts, USA
Development of carbohydrate drugs through phase 3 clinical trials
Research Interests
Honors & Awards
Publications