Vice President, Chemistry, Manufacturing and Controls (CMC)

Our client is a well-financed, venture-backed clinical-stage biotechnology company built around a platform designed to improve upon existing therapeutic agents in a large, validated disease area. The company's discovery and early development work is led by an experienced protein engineering and company-building team with a strong track record of advancing programs into the clinic and building successful biotech companies.

They are seeking Vice President of CMC to lead end-to-end chemistry, manufacturing and controls strategy for the company's lead program and pipeline as it advances toward IND-enabling and first-in-human milestones. This is a critical, value-defining role with full accountability for drug substance, drug product (formulation), analytical, QC, device, and the company's external manufacturing network.

• Own CMC strategy across drug substance, drug product (formulation), analytical, QC, and device development
• Align CMC plans with clinical, regulatory, and corporate milestones, including upcoming regulatory filings to support first-in-human studies
• Build and execute the CMC roadmap supporting healthy volunteer data and early clinical proof-of-concept data

• Lead drug substance and drug product process and analytical technology transfer across external partners
• Oversee process development, scale-up, and clinical manufacturing through IND-enabling and early clinical stages
• Ensure continuity of supply and manufacturing robustness across the network
• Direct device and drug product integration for combination product strategy

• Build and manage the company's fully outsourced CMC network across drug substance, drug product, analytical, and device work streams
• Establish governance, performance metrics, and risk mitigation across CDMO relationships
• Negotiate and manage key vendor and CDMO relationships, including technology transfer and capacity planning

• Partner with Quality and Regulatory functions to ensure compliance and inspection readiness across the CDMO network
• Own CMC sections of regulatory filings supporting first-in-human and subsequent clinical studies
• Lead responses to regulatory questions related to CMC

• Build and scale the CMC/Technical Operations function as the company grows
• Hire and develop internal talent while leveraging external expertise and CDMO partners
• Establish systems, processes, and infrastructure appropriate for a lean, outsourced operating model

• 15+ years in biologics CMC, with progressive leadership across drug substance, drug product, analytical, QC, and/or device functions
• Prior leadership role with end-to-end CMC accountability
• Experience advancing biologic programs from preclinical through IND filing; experience through late stage/BLA is a plus.
• Deep experience managing external CDMO networks in a fully outsourced model
• Hands‑on experience with technology transfer and process validation
• Experience with devices and combination products preferred but not required
• Proven ability to operate in lean, high-impact environments with limited internal infrastructure
• Strong execution mindset with the ability to manage complex, parallel work streams
• Strong written and oral communicator, credible in front of board members and investors
• Builder mentality, comfortable establishing a function rather than only operating within one