Executive Director, MSAT - Type 1 Diabetes

Overview 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). It 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. Key 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. 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. Pay Range $249,400 - $374,200. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Base salary will be based on skills, competencies, experience and other job‑related factors permitted by law. Flex Designation On‑site. You will work five days per week on‑site with ad‑hoc flexibility. The Flex status is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. Benefits Medical, dental, and vision benefits; generous paid time off including a company shutdown each year; educational assistance programs; commuting subsidy; charitable donation matching; 401(k) and more. Benefits are designed to meet employees at all stages of their career. Equal Employment Opportunity Vertex is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E‑Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position should make a request to the recruiter or hiring manager, or contact Talent Acquisition at View email address on click.appcast.io. #J-18808-Ljbffr Vertex Pharmaceuticals Inc (US)