Position Overview
We are seeking a strategic and execution-oriented Vice President of Global Supply & External Manufacturing to lead the development and scaling of our end-to-end supply chain and external manufacturing network. This individual will be responsible for ensuring reliable, compliant, and cost-effective supply across clinical and commercial programs, spanning multiple therapeutic modalities.
The VP will play a critical leadership role in building and managing a global network of CDMOs, driving tech transfer and commercialization readiness, and partnering cross-functionally with CMC, Quality, Regulatory, and Clinical Operations to support the advancement of our pipeline.
Key Responsibilities
Global Supply Strategy
- Define and execute the global supply chain strategy across clinical and commercial stages
- Establish scalable supply models to support pipeline growth and product launches
- Lead S&OP processes, demand planning, and inventory strategies across regions
External Manufacturing Leadership
- Build and oversee a global network of CDMOs for drug substance, drug product, and fill-finish operations
- Lead CDMO selection, qualification, contracting, and ongoing performance management
- Establish governance frameworks, KPIs, and business review processes with external partners
Tech Transfer & Scale-Up
- Oversee all technology transfer activities from internal development to external manufacturing partners
- Ensure successful scale-up from early clinical through commercial production
- Drive process robustness, reproducibility, and manufacturing readiness
Clinical & Commercial Supply
- Ensure uninterrupted supply of clinical trial materials globally
- Lead commercialization readiness efforts, including launch supply planning and distribution strategy
- Develop supply continuity and risk mitigation plans, including dual sourcing strategies
Regulatory & Quality Alignment
- Partner closely with Quality and Regulatory teams to ensure compliance with FDA, EMA, and global health authorities
- Support CMC sections of regulatory filings (IND, BLA, MAA)
- Ensure inspection readiness across all external manufacturing sites
Financial & Operational Excellence
- Own and manage supply chain and external manufacturing budgets
- Drive cost of goods optimization and long-term cost reduction strategies
- Lead contract negotiations and manage multimillion-dollar CDMO agreements
Leadership & Cross-Functional Collaboration
- Build, lead, and develop a high-performing global team across supply chain and external manufacturing
- Serve as a key member of the Technical Operations leadership team
- Collaborate cross-functionally with CMC, Clinical, Commercial, and Finance to align on program priorities
Qualifications
Required
- Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred
- 15+ years of experience in biopharmaceutical manufacturing, supply chain, or technical operations
- Significant leadership experience in external manufacturing and CDMO management
- Proven track record supporting products from early development through commercialization
- Deep understanding of global regulatory requirements and GxP compliance
- Experience managing global supply chains across multiple regions
- Demonstrated ability to lead large, cross-functional teams and influence at the executive level
