Executive Director, Manufacturing Operations - T1D

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 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: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: 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. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. 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 for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at View email address on click.appcast.io Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency . Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on Facebook, Twitter/X , LinkedIn, YouTube and Instagram. The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives. Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.