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:

Disclosure Statement:

Flex Designation:

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 [email protected]