Job Description

General Summary:

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.

Pay Range:
$249,400 - $374,200

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. 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. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:
On-Site Designated

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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