Yuan-Hon Kiang
Scientific Director | Small Molecule Product Development & CMC | Solid-State, Pre-formulation & Formulation | From Early Development to Commercialization
- Role
- Scientific Director at Amgen
- Location
- Ventura County, CA, US
- LinkedIn followers
- 500 followers
About Yuan-Hon Kiang
Pharmaceutical scientist with 25 years of experience in small molecule drug product…
Experience
Scientific Director
Sep 2004 — Present · Thousand Oaks, CA, US
Lead small molecule drug product development from discovery through commercialization, supporting the full product lifecycle. Oversee cross-functional CMC teams, guide formulation strategies, and ensure smooth transitions from early development to commercial manufacturing. Currently supervise 13 PhD, MS, and BS-level scientists while fostering innovation in drug product design and process optimization.Key Accomplishments: Led the development of LUMAKRAS® 320 mg Tablet, achieving FDA approval under highly accelerated timelines. Directed late-stage development for omecamtiv mecarbil, leading to NDA submission of a multi-strength modified-release matrix tablet formulation. Spearheaded azelaprag Phase 1 formulation development, delivering both oral and IV formulations while mitigating early solid-state risks. Managed multiple teams to design and develop robust formulations across IR/MR tablets, capsules, and IV solutions. Authored major regulatory submissions (MAA, PAS, CTAs) and supported successful CMC interactions with the FDA and global health authorities. Hands-on GMP manufacturing experience including tech transfer to CMOs, and on-site production oversight.
Education
Cornell University
Doctor of Philosophy - PhD
University of Michigan
Master of Science - MS
National Taiwan University
Bachelor of Science - BS
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