Executive Director, MSAT – Type 1 Diabetes

Vertex Inc.•Boston, MA

2d•$249,400 - $374,200•Onsite

About The Position

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.

Requirements

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.
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.
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.

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.