Executive Director, MSAT – Type 1 Diabetes
Vertex Pharmaceuticals
June 26, 2026
On-site
Boston, MA
Operations
General Summary
- Executive Director, MSAT provides strategic and hands-on leadership for Manufacturing Science & Technology (MSAT) across a Type 1 Diabetes cell therapy manufacturing network, focused on external manufacturing partners (CMOs). Accountable for process performance, technical transfer, validation, continued process verification, comparability, and lifecycle management.
Key Duties & Responsibilities
- Define and execute MSAT strategy across global external network; establish governance for CMO engagement (forums, escalation, performance metrics); set harmonized technical standards.
- Lead right-first-time technology transfer and integrated readiness for pivotal trials and commercialization (facility/equipment/material qualification, batch records, manufacturing execution).
- Own/evolve control strategy with CMC, Quality, and Regulatory; lead process validation/PPQ (sampling, acceptance criteria, statistics, continued verification); align CPPs/CQAs and in-process controls.
- Build CPV/trending program (yield, purity, potency, viability, cycle time, deviations, release); lead investigations/risk assessments for major deviations/OOS/OOT and drive CAPAs and improvements.
- Lead change control execution across sites; own comparability strategies; support IND/BLA/MAA content and HA questions/commitments.
- Provide MSAT leadership for materials/supplier technical oversight and risk management.
- Champion digital/automation enablement (MES/eBR, historian integration, data pipelines/analytics; closed-system solutions).
- Build and lead MSAT teams; foster scientific rigor and cross-functional collaboration.
Knowledge, Skills & Experience
- Deep GMP knowledge for advanced therapies and late-stage readiness (validation, CPV, inspection readiness).
- Strong experience with control strategy, process characterization, lifecycle management, deviations/investigations, change control, and comparability across multi-site networks.
- Advanced degree (MS/PhD preferred) in chemical/biomedical/biotechnology/life sciences.
- 15+ years in biopharmaceuticals with progressive MSAT/manufacturing/process leadership; significant cell therapy/advanced biologics experience.
- Demonstrated success in external manufacturing tech transfers and CMO-centric/hybrid models; strong executive communication and influence.
Pay Range
- $249,400 - $374,200.
- Executive Director, MSAT provides strategic and hands-on leadership for Manufacturing Science & Technology (MSAT) across a Type 1 Diabetes cell therapy manufacturing network, focused on external manufacturing partners (CMOs). Accountable for process performance, technical transfer, validation, continued process verification, comparability, and lifecycle management.
Key Duties & Responsibilities
- Define and execute MSAT strategy across global external network; establish governance for CMO engagement (forums, escalation, performance metrics); set harmonized technical standards.
- Lead right-first-time technology transfer and integrated readiness for pivotal trials and commercialization (facility/equipment/material qualification, batch records, manufacturing execution).
- Own/evolve control strategy with CMC, Quality, and Regulatory; lead process validation/PPQ (sampling, acceptance criteria, statistics, continued verification); align CPPs/CQAs and in-process controls.
- Build CPV/trending program (yield, purity, potency, viability, cycle time, deviations, release); lead investigations/risk assessments for major deviations/OOS/OOT and drive CAPAs and improvements.
- Lead change control execution across sites; own comparability strategies; support IND/BLA/MAA content and HA questions/commitments.
- Provide MSAT leadership for materials/supplier technical oversight and risk management.
- Champion digital/automation enablement (MES/eBR, historian integration, data pipelines/analytics; closed-system solutions).
- Build and lead MSAT teams; foster scientific rigor and cross-functional collaboration.
Knowledge, Skills & Experience
- Deep GMP knowledge for advanced therapies and late-stage readiness (validation, CPV, inspection readiness).
- Strong experience with control strategy, process characterization, lifecycle management, deviations/investigations, change control, and comparability across multi-site networks.
- Advanced degree (MS/PhD preferred) in chemical/biomedical/biotechnology/life sciences.
- 15+ years in biopharmaceuticals with progressive MSAT/manufacturing/process leadership; significant cell therapy/advanced biologics experience.
- Demonstrated success in external manufacturing tech transfers and CMO-centric/hybrid models; strong executive communication and influence.
Pay Range
- $249,400 - $374,200.