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
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
QUALIFICATIONS
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
PREFERRED REQUIREMENTS
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)
LOCATION Remote (in the United States)
SALARY USD170,000-300,000
BENEFITS Medical, dental vision, and others
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