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. 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.
Key Duties and Responsibilities:
MSAT Strategy & Network Leadership
- 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.
Tech Transfer & Manufacturing Readiness
- 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/eBR/MES).
- Ensure robust site onboarding and sustained technical engagement—acting as the technical lead for process execution performance.
Process Characterization, Control Strategy & Validation
- 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.
Continued Process Verification (CPV), Trending & Operational Excellence
- 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.
Change Control, Comparability & Lifecycle Management
- 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.
Materials, Raw Materials & Supplier Technical Oversight
- 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.
Digital, Automation & Data Systems Enablement
- Champion digital enablement of manufacturing—MES/eBR, 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.
People Leadership & Vertex Culture
- 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 compliance.
Knowledge and Skills:
Technical Expertise
- Deep understanding of GMP expectations for advanced therapies and late-stage readiness (validation, CPV, inspection readiness).
- Proven capability in control strategy development, process characterization, and lifecycle management.
- 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.
