What are the responsibilities and job description for the Head of Manufacturing position at Hartmann Young?
🚀 Head of CMC (Small Molecules)
I’m partnering with a recently funded, commercial-stage biotech seeking a hands-on, strategic CMC leader to drive their small molecule programs from late-stage development to commercial launch.
This is a high-impact role for someone with proven experience taking small molecules through NDA/MAA approval and launch.
Key Responsibilities:
- Lead end-to-end CMC strategy for late-stage and commercial programs.
- Oversee process chemistry, analytical, formulation development, and manufacturing scale-up.
- Drive tech transfer, process validation, and commercial readiness at global CMOs.
- Partner with Regulatory Affairs on NDA/MAA submissions.
- Build and mentor a high-performing internal team and manage external partners.
What They’re Looking For:
- 15 years in small molecule CMC, with expertise in API and drug product.
- Experience with global CMOs/CROs and GMP systems.
This is a rare opportunity to join a growing biotech at commercial stage, where your leadership will directly shape product launch and global impact.
