Job Details

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