POSITION TITLE Head of CMC / VP of CMC
Position Summary
In this position, you will play a critical role in leading CMC strategy from late‑stage clinical development through regulatory approval and commercial launch.
Responsibilities
SALARY USD170,000-300,000
Benefits
BENEFITS Medical , dental vision, and others
#countryUS
Position Summary
In this position, you will play a critical role in leading CMC strategy from late‑stage clinical development through regulatory approval and commercial launch.
Responsibilities
- Develop and execute CMC strategies across clinical and commercial stages
- Oversee API and drug product development, scale‑up, and tech transfer with CDMOs
- Author and review CMC sections (Module 3, QOS) of global regulatory submissions (IND, IMPD, NDA/BLA, MAA)
- Provide CMC support for regulatory authority interactions
- Ensure cGMP compliance; manage QA activities including deviations, batch record review, and lot disposition
- Select and manage CDMOs, testing labs, and suppliers
- Manage DP manufacturing budget and long‑range planning
- Collaborate cross‑functionally with Clinical, Regulatory, QA, and Commercial teams
- Minimum 10 years of CMC experience in biotech/pharma
- At least 5 years in late‑stage development or commercial stage
- Experience managing CDMOs
- Solid understanding of regulatory requirements
- Strong communication skills in English and/or Japanese
- Ability to thrive in a lean, fast‑moving environment
- PhD, PharmD, or MS in pharmaceutical sciences, chemistry, chemical engineering, or related field
- Experience leading CMC sections of global filings (IND/IMPD/NDA/BLA/MAA)
- Experience with drug–device combination products (if applicable)
SALARY USD170,000-300,000
Benefits
BENEFITS Medical , dental vision, and others
#countryUS