At HIL CMC Consulting, we partner with pharmaceutical and biotech innovators to design and execute robust, phase-appropriate CMC strategies that accelerate development and enable regulatory success. We combine deep scientific expertise with practical, real-world execution to move programs efficiently from concept to commercialization.
To transform complex CMC challenges into clear, science-based strategies that move molecules efficiently from lab to market.
Science-driven approach grounded in real development experience
Integrated perspective across process chemistry, regulatory CMC, and global manufacturing
Pragmatic, execution-focused guidance built for real timelines—not just slide decks
Independent and unbiased advisory not influenced by vendor or platform bias
2025
Titusville, NJ
Pharmaceutical & Biotechnology Consulting
Drug Substance Development
Chemical Process R&D
CMC Strategy & Regulatory Planning (IND/NDA)
External Manufacturing & Vendor Management
Technology Transfer & Manufacturing Readiness
DoE & QbD–based development
Due Diligence & Technical Assessment
Risk Assessment & Mitigation
Fractional CMC Leadership
We believe successful CMC development requires a balance of scientific rigor, regulatory awareness, and practical manufacturing execution. Our work is built on collaboration, transparency, and an understanding of what teams need to deliver results that last.
With more than 20 years of hands-on leadership in CMC development, process chemistry, and global CDMO management, Dr. Lee brings a proven track record of advancing small-molecule programs across all stages of development. His experience spans roles at Boehringer Ingelheim, Scynexis, and Arrow Ventures, where he advises on technical due diligence and development strategy.