Executive Director, Manufacturing Operations – T1D
Vertex Pharmaceuticals
June 26, 2026
Remote friendly (Boston, MA)
United States
Operations
General Summary:
- Build and lead a global external manufacturing network for Type 1 Diabetes cell therapy programs.
- Provide strategy, governance, and operational oversight of Contract Manufacturing Organizations (CMOs), ensuring quality, reliability, and scalability for clinical development and commercialization.
Key Duties and Responsibilities:
- External Manufacturing Strategy & Network Leadership: Define/execute external manufacturing strategy; build resilient CMO/supplier network; lead CMO governance; establish partnership models.
- CMO Partnership & Oversight: Oversee manufacturing execution at CMO sites; drive safety/quality/delivery/cost performance via KPIs; maintain on-site presence; identify and mitigate supply/operational risks.
- Tech Transfer & Operational Readiness: Partner with MSAT and CMC for tech transfer; oversee validation, comparability, and lifecycle management; plan to enable pivotal trials and commercial launch.
- Quality & Compliance: Ensure GMP compliance; support inspection readiness and regulatory filings; manage deviations, change control, and CAPA.
- Supply Chain & Integration: Integrate CMOs into end-to-end supply chain; ensure chain-of-identity and chain-of-custody; manage key supplier relationships.
- Financial & Investment Stewardship: Oversee budgets/contracts/capital investments; ensure ROI; negotiate/manage CMO agreements.
- Cross-Functional Leadership: Partner with Technical Operations/CMC/Regulatory/Quality/Supply Chain; support IND/BLA/MAA; lead team and develop capabilities.
Knowledge and Skills:
- GMP and global regulatory knowledge (FDA, EMA, ICH); multi-site tech transfer/process validation/lifecycle management; advanced therapy supply-chain familiarity; lead through influence in matrixed environments; partnership orientation; strategic execution.
Education and Experience:
- MS/PhD (or equivalent) in life sciences/engineering; 15+ years biopharma manufacturing with senior leadership; deep CMO/external network experience in GMP; cell/gene therapy experience strongly preferred; track record supporting clinical and commercial supply.
Benefits:
- Annual bonus; annual equity awards.
Application instructions:
- Contact Talent Acquisition at ApplicationAssistance@vrtx.com for hiring-process accommodation requests.
- Build and lead a global external manufacturing network for Type 1 Diabetes cell therapy programs.
- Provide strategy, governance, and operational oversight of Contract Manufacturing Organizations (CMOs), ensuring quality, reliability, and scalability for clinical development and commercialization.
Key Duties and Responsibilities:
- External Manufacturing Strategy & Network Leadership: Define/execute external manufacturing strategy; build resilient CMO/supplier network; lead CMO governance; establish partnership models.
- CMO Partnership & Oversight: Oversee manufacturing execution at CMO sites; drive safety/quality/delivery/cost performance via KPIs; maintain on-site presence; identify and mitigate supply/operational risks.
- Tech Transfer & Operational Readiness: Partner with MSAT and CMC for tech transfer; oversee validation, comparability, and lifecycle management; plan to enable pivotal trials and commercial launch.
- Quality & Compliance: Ensure GMP compliance; support inspection readiness and regulatory filings; manage deviations, change control, and CAPA.
- Supply Chain & Integration: Integrate CMOs into end-to-end supply chain; ensure chain-of-identity and chain-of-custody; manage key supplier relationships.
- Financial & Investment Stewardship: Oversee budgets/contracts/capital investments; ensure ROI; negotiate/manage CMO agreements.
- Cross-Functional Leadership: Partner with Technical Operations/CMC/Regulatory/Quality/Supply Chain; support IND/BLA/MAA; lead team and develop capabilities.
Knowledge and Skills:
- GMP and global regulatory knowledge (FDA, EMA, ICH); multi-site tech transfer/process validation/lifecycle management; advanced therapy supply-chain familiarity; lead through influence in matrixed environments; partnership orientation; strategic execution.
Education and Experience:
- MS/PhD (or equivalent) in life sciences/engineering; 15+ years biopharma manufacturing with senior leadership; deep CMO/external network experience in GMP; cell/gene therapy experience strongly preferred; track record supporting clinical and commercial supply.
Benefits:
- Annual bonus; annual equity awards.
Application instructions:
- Contact Talent Acquisition at ApplicationAssistance@vrtx.com for hiring-process accommodation requests.