Executive Director, MSAT – Type Diabetes

Executive Director, MSAT

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. This role is accountable for process performance, technical transfer, validation, continued process verification, comparability, and lifecycle management—with a particular focus on external manufacturing partners (CMOs).

You will build and lead a high-performing MSAT organization that bridges Process Development and GMP Manufacturing, ensuring processes are robust, scalable, compliant, and inspection-ready from early clinical supply through commercialization. This is a highly cross-functional leadership position partnering with Technical Operations, Quality, CMC, Regulatory, Supply Chain, and external manufacturing partners.

• 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.
• Set technical standards and harmonized approaches across sites for process control, process validation, deviation management, and lifecycle improvements.
• Partner with Process Development to ensure right-first-time technology transfer into external manufacturing sites, ensuring operationalization of process knowledge, documentation readiness, and training for GMP execution.
• Drive integrated readiness plans for pivotal trials and commercial launch: facility fit, equipment strategy, material qualification, batch records, and manufacturing execution (paper/e /MES).
• Ensure robust site onboarding and sustained technical engagement—acting as the technical lead for process execution performance.
• 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.
• Ensure alignment of critical process parameters (CPPs), critical quality attributes (CQAs), and in-process controls across sites.
• Build a best-in-class CPV and trending program across the network: yield, purity, potency, viability, cycle time, deviations, and release performance.
• Lead investigations and technical risk assessments for major deviations, OOS/OOT, and atypical events—ensuring timely root cause, effective CAPAs, and sustained improvements.
• 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).
• Partner with Supply Chain and Quality to ensure technical oversight for supplier network robustness, including dual sourcing strategies where appropriate.
• Champion digital enablement of manufacturing—MES/e , historian integration, data pipelines, and analytics to improve right-first-time execution.
• Promote automation and closed-system solutions where feasible to enhance robustness, reduce variability, and improve scalability.
• Build, mentor, and lead a high-impact MSAT organization across disciplines (process engineers, tech transfer leads, validation engineers, data/trending experts).
• Foster a culture of scientific rigor, transparency, collaboration, and urgency for patients—balancing speed with quality and…