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Jobs · Business Development · Massachusetts

Executive Director, MSAT – Type 1 Diabetes

Vertex Pharmaceuticals · Boston, MA · 3 wk ago
On-siteBusiness Development$249k–$374k/yrFull-time

General Summary

At Vertex, we’re driven by a shared purpose: to transform the lives of patients with serious diseases. The Executive Director, MSAT will provide strategic and hands-on leadership for Manufacturing Science & Technology (MSAT) across our Type 1 Diabetes cell therapy manufacturing network.

Key Duties And Responsibilities

  • Define and execute the MSAT strategy for T1D cell therapy manufacturing across a global external network, ensuring technical readiness for clinical development and commercial launch.

  • Establish and lead governance models for MSAT engagement with CMOs and co-invested sites, including joint technical forums, escalation pathways, and performance metrics.

  • Own and evolve the control strategy in partnership with CMC, Quality, and Regulatory, ensuring scientifically sound and phase-appropriate controls.

  • Lead process validation/PPQ strategies, including sampling plans, acceptance criteria, statistical approaches, and continued verification.

  • Build a best-in-class CPV and trending program across the network: yield, purity, potency, viability, cycle time, deviations, and release performance.

  • Drive continuous improvement through process optimization, standardization, and lean problem solving, while maintaining compliance.

  • Lead technical assessment and execution of change control across external sites (process, analytical, equipment, raw materials, suppliers).

  • Own comparability strategies for process changes and site transfers, ensuring robust data packages for regulatory submissions and inspection readiness.

  • Partner with Regulatory CMC to support IND/BLA/MAA content, HA questions, and commitments related to process and control strategy.

  • Provide MSAT leadership for material qualification, supplier changes, and risk management (critical raw materials, reagents, single-use systems).

  • Enable digital, automation, and data systems within the manufacturing environment, promoting MES/eBR, historian integration, data pipelines, and analytics to improve right-first-time execution.

  • Build, mentor, and lead a high-impact MSAT organization across disciplines (process engineers, tech transfer leads, validation engineers, data/trending experts).

Technical Expertise

  • Deep understanding of GMP expectations for advanced therapies and late-stage readiness (validation, CPV, inspection readiness).

  • Strong experience with deviations/investigations, change control, and comparability strategies across multi-site networks.

  • Working knowledge of analytics strategy interface (method readiness, tech transfer, comparability support) and how it ties to product control.

Leadership & Influence

  • Demonstrated ability to lead through influence in complex, matrixed organizations and across external partner boundaries.

  • Strong executive communication skills with the ability to simplify complexity, drive alignment, and make risk-based decisions.

  • Track record of building high-performing teams and developing technical talent.

Education And Experience

  • Advanced degree (MS/PhD preferred) in Chemical Engineering, Biomedical Engineering, Biotechnology, Life Sciences, or related discipline.

  • 15+ years of biopharmaceutical experience with progressive leadership in MSAT/Manufacturing/Process Engineering roles.

  • Significant experience in cell therapy and/or advanced biologics manufacturing; experience supporting both clinical and commercial programs strongly preferred.

  • Demonstrated success leading external manufacturing tech transfers and operating in CMO-centric or hybrid manufacturing models.

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