Executive Director, Manufacturing Operations - T1D

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Job Description General Summary: At Vertex, we are driven by a shared commitment to transform the lives of patients with serious diseases. The Executive Director, Manufacturing Operations will play a critical leadership role in delivering on this mission by building and leading a global external manufacturing network for our Type 1 Diabetes cell therapy programs. This role is accountable for the strategy, governance, and operational oversight of Contract Manufacturing Organizations (CMOs). The leader will operate as a strategic partner to these organizations, ensuring the highest standards of quality, reliability, and scalability to support clinical development and commercialization. Key Duties and Responsibilities: External Manufacturing Strategy & Network Leadership Define and execute a phase-appropriate external manufacturing strategy aligned with Vertex's pipeline and long-term commercial vision Build and operate a resilient, scalable network of CMOs and critical suppliers Lead governance of contract manufacturing facilities, ensuring strong alignment on performance, quality, and continuous improvement Establish transparent and effective partnership models with CMOs grounded in trust, accountability, and shared goals CMO Partnership & Oversight Serve as the primary operations leader overseeing manufacturing execution at CMO sites Drive performance across safety, quality, delivery, and cost through clear KPIs and active engagement Maintain strong on-site presence and partnership mindset while holding CMOs accountable to Vertex standards Identify and proactively mitigate supply and operational risks across the network Tech Transfer & Operational Readiness Partner with MSAT and CMC teams to ensure seamless tech transfer into external facilities Oversee process validation, comparability, and lifecycle management across multiple sites Enable readiness for pivotal trials and commercial launch through disciplined planning and execution Quality & Compliance Champion Vertex's commitment to quality and patients by ensuring full GMP compliance across all CMO operations Partner closely with Quality to maintain continuous inspection readiness and support regulatory filings and inspections Ensure robust quality systems, including deviation, change control, and CAPA management across the external network Supply Chain & Integration Integrate CMOs into Vertex's end-to-end supply chain, including raw materials, critical reagents, and logistics Ensure chain-of-identity and chain-of-custody integrity for cell therapy products Build strong, strategic relationships with key suppliers to ensure continuity and performance Financial & Investment Stewardship Oversee budgets, contracts, and capital investments associated with co-invested facilities Ensure strong financial governance and return on investment for Vertex-funded manufacturing assets Negotiate and manage CMO agreements to align incentives and performance outcomes Cross-Functional Leadership Partner across Technical Operations, CMC, Regulatory, Quality, and Supply Chain to deliver integrated solutions Contribute to regulatory submissions (IND, BLA/MAA) and represent Manufacturing Operations in inspections and agency interactions Team Leadership & Culture Build and lead a high-performing team aligned with Vertex's values: innovation, integrity, collaboration, and urgency for patients Foster a culture of ownership, transparency, and continuous improvement Develop organizational capabilities in external manufacturing, technical oversight, and partnership management Knowledge and Skills: Strong understanding of GMP and global regulatory expectations (FDA, EMA, ICH) Experience with multi-site tech transfer, process validation, and lifecycle management Familiarity with advanced therapy supply chains, including traceability and cold chain logistics Demonstrated ability to lead through influence in complex, matrixed environments Strong partnership orientation with the ability to build trust while driving accountability Strategic mindset with disciplined operational execution Education and Experience: Advanced degree (MS, PhD, or equivalent) in life sciences, engineering, or related field 15+ years of biopharmaceutical manufacturing experience, including senior leadership roles Deep experience managing CMOs and external manufacturing networks in a GMP environment Experience in cell and/or gene therapy manufacturing strongly preferred Proven track record supporting both clinical and commercial supply Pay Range: $252,300 - $378,500 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

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