Head of Manufacturing

Hartmann Young; United States; On-site; USD 125,000 - 150,000; Full time

Job summary

A leading commercial-stage biotech in the United States is seeking a Head of CMC. The ideal candidate has over 15 years of experience in small molecule CMC and will lead the end-to-end strategy for late-stage and commercial programs. This high-impact role offers a unique opportunity to influence product launch and global impact.

Qualifications

• 15+ years in small molecule CMC with expertise in API and drug product.
• Experience with global CMOs/CROs and GMP systems.

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.

Skills

Experience in small molecule CMC

Leadership abilities

Strategic thinking

Job description

🚀 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.