Dr. Hyoung Lee is the Founder and Principal Consultant of HIL CMC Consulting LLC, where he provides science-driven CMC strategy, process development expertise, and external manufacturing leadership to pharmaceutical and biotechnology innovators. With more than 20 years of hands-on experience in small-molecule CMC development, he brings a unique combination of technical depth, regulatory understanding, and real-world execution across global development programs.
Dr. Lee currently also serves as a CMC Advisor at Arrow Ventures, supporting technical due diligence and development strategy for early- and mid-stage investment programs.
A career built on advancing science from concept to commercialization
Founder & Principal Consultant — HIL CMC Consulting LLC
CMC Advisor — Arrow Ventures
Scientific & Leadership Roles — Boehringer Ingelheim
Process Chemistry / R&D — Scynexis / Avista Pharma
Process Development & Chemistry Roles — Multiple research and engineering positions
CMC development & regulatory strategy (IND/NDA)
Route design, optimization, and process scale-up (grams → 100+ kg)
CDMO evaluation, selection, negotiation & oversight
Technology transfer & manufacturing readiness
DoE / QbD–based development & lifecycle process understanding
Risk assessment, mitigation & technical problem solving
Due diligence & technical assessment for investors and licensing decisions
Fractional CMC leadership for growing development organizations
Dr. Lee’s work is grounded in the belief that successful CMC development requires alignment between scientific rigor, regulatory expectations, and operational realities. Across his career, he has partnered with multidisciplinary teams spanning R&D, QA, regulatory affairs, and global manufacturing, delivering practical solutions that accelerate development and reduce risk.
University of Alabama
Seoul National University
“My purpose is to partner with innovators who are advancing meaningful science and guide them through the complex technical and regulatory landscape required to bring high-quality medicines to patients. I believe in practical, transparent execution — where data, strategy, and collaboration work together to drive real progress.”
If your organization is seeking CMC strategy, process development support, technical due diligence, or external manufacturing leadership, I’d welcome a conversation.