Job Details

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