Senior Director Manufacturing
Hartmann Young, San Francisco, CA, United States
Senior Director, CMC (Chemistry, Manufacturing & Controls)
Our client is seeking a highly experienced CMC leader to take ownership of manufacturing strategy and execution across a next-generation cell therapy pipeline.
This is a critical leadership role at the heart of translating science into scalable, high-quality, and regulatory-ready therapies.
What You’ll Do
- Lead end-to-end CMC strategy across cell therapy manufacturing programs
- Drive CDMO evaluation, selection, and long-term partnership management
- Oversee tech transfer from process development into GMP manufacturing
- Build and maintain a robust path toward scale-up and commercial readiness
- Own CMC content for INDs and regulatory submissions
- Ensure alignment between manufacturing, clinical timelines, and regulatory requirements
- Drive continuous improvement in cost, quality, yield, and speed of manufacturing processes
What We’re Looking For
- Strong background in biologics or cell therapy manufacturing (deep hands‑on expertise required)
- Proven experience managing CDMOs and external manufacturing partners
- Track record supporting IND-stage or early clinical‑stage programs
- Experience with tech transfer, GMP readiness, and scale‑up of complex biologics or cell‑based therapies
- Senior Director‑level experience in biotech or advanced therapeutics
- Strong cross‑functional leadership skills across CMC, Clinical, and Regulatory teams
Why This Role
- Own the manufacturing backbone of a cutting‑edge cell therapy pipeline
- Directly influence speed, cost, and success of clinical development
- Work closely with executive leadership and technical founders
- Help build the infrastructure for late‑stage and commercial readiness