Phone: (267) 948-1436
Position Overview
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.
Key Responsibilities:
CMC Strategy and Leadership
- 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
Technology Transfer and Manufacturing Oversight
- 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
External Manufacturing Network Management
- Build and manage the company’s fully outsourced CMC network across drug substance, drug product, analytical, and device workstreams
- Establish governance, performance metrics, and risk mitigation across CDMO relationships
- Negotiate and manage key vendor and CDMO relationships, including technology transfer and capacity planning
Quality and Regulatory Interface
- 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
Organizational Build-Out
- 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
Key Requirements:
- 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 workstreams
- 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
Location(s)
If interested, please send a MS Word version of your resume to [email protected]
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