Vice President of Chemistry, Manufacturing & Controls (CMC)

Vice President of Chemistry, Manufacturing & Controls (CMC)

About the Company

Well-financed, venture-backed clinical-stage biotechnology company developing improved therapeutic agents.

Industry
Biotechnology

Type
Privately Held, VC-backed

About the Role

The Company is in search of a Vice President of CMC to take on a pivotal role in leading the end-to-end chemistry, manufacturing, and controls strategy for its lead program and pipeline. The successful candidate will be responsible for aligning CMC plans with clinical, regulatory, and corporate milestones, and will play a key part in the company's advancement toward IND-enabling and first-in-human milestones. This role demands a seasoned professional with a minimum of 15 years' experience in biologics CMC, including a proven track record of progressive leadership across various CMC functions. The VP of CMC will be tasked with building and executing the CMC roadmap, overseeing technology transfer, and ensuring the robustness of the external manufacturing network. A strong background in managing external CDMO networks and a hands-on approach to technology transfer and process validation are essential. Experience with devices and combination products is preferred, and the ideal candidate will have a builder mentality, capable of scaling the CMC/Technical Operations function as the company grows. Key requirements for the role include a leadership position with end-to-end CMC accountability, experience in advancing biologic programs from preclinical through IND filing, and the ability to operate in lean, high-impact environments. The role also involves close collaboration with quality and regulatory functions, and the VP of CMC will be expected to lead the CMC sections of regulatory filings and respond to regulatory questions. The candidate should be a strong communicator, both in written and oral forms, and be credible in front of board members and investors. The position is critical to the company's mission of advancing therapeutic agents in a large, validated disease area, and the VP of CMC will be instrumental in the organizational build-out, including hiring and developing internal talent and establishing the necessary systems and processes for a lean, outsourced operating model.

Functions

• Operations
• Engineering