External Manufacturing Associate Director

Role Summary

The Associate Director, External Manufacturing Operations is responsible for overseeing Vertex’s cell and gene therapy CMOs and driving the strategy to manage cGMP supply from clinical through post-approval lifecycle. The role requires coordinating with internal and external partners to ensure on-time, compliant, and cost-effective manufacturing and supply. The individual will act as a key member of the Vertex/CMO Virtual Plant Team, with on-site presence at CMOs as needed and up to 50% travel to oversee activities.

Responsibilities

• Function as the primary Vertex contact for ATMP cell and gene therapy CMOs.
• Provide operational oversight and troubleshooting to CMOs to meet Vertex and regulatory requirements, ensuring right-first-time execution of commercial operations.
• Lead cross-functional efforts to address emerging trends and issues, minimizing impact on compliance and supply.
• Maintain on-site presence at CMOs to oversee critical program activities, manufacturing, and Health Authority inspections.
• Leverage Technical, Quality, and Regulatory SMEs to guide CMOs and align program priorities from clinical to commercial manufacturing.
• Coordinate contract management, KPI tracking, forecast communication, schedule alignment, supplier governance, and finance activities with internal and external stakeholders.
• Manage and track CMO performance before, during, and after manufacturing, including campaign summaries/reports.
• Ensure compliant data handling for batch data and support submissions, patient planning, and process optimization.
• Collaborate to deliver compliance documentation (change controls, investigations, deviations, CAPAs, audits) and meet regulatory commitments.
• Escalate business-critical issues to leadership and collaborate on end-to-end implementation of changes (including change controls and impact assessments).
• Lead continuous improvement initiatives to resolve supply issues promptly.
• Develop and maintain strategic relationships with CMOs and internal stakeholders.

Qualifications

• Required: Bachelor's degree in cell biology or closely related Life Sciences (Immunology, Microbiology, Cell Biology, Engineering, etc.) with 10+ years of relevant biotech/pharma experience, preferably in senior manufacturing/operations leadership within cGMP facilities.
• Required: Strong quality and compliance background in commercial GMP biopharmaceutical operations; knowledge of health authority regulations.
• Required: Strong technical background in aseptic manufacturing operations.
• Required: Solid project management skills and experience managing complex projects.
• Required: Excellent verbal and written communication; ability to tailor messaging to audiences.
• Required: Strong leadership and collaboration skills; ability to build relationships.
• Required: Ability to work calmly and decisively in a fast-moving environment.
• Required: Flexibility to work shift hours to cover critical process steps.
• Required: Ability to travel nationally and internationally up to 50%.
• Required: Proficient computer skills (Microsoft Word, Excel, Project, Outlook, Teams) and experience with electronic quality systems.
• Preferred: Strong technical background in cell and gene therapy manufacturing operations, ideally autologous cell therapy experience.
• Preferred: Experience with equipment and facility qualification/validation for ATMP CMOs; cleanroom qualification history (Grade A/B).

Skills

• Leadership and cross-functional collaboration
• Strategic supplier and contract management
• Risk assessment and problem-solving in manufacturing supply chains
• Regulatory and quality systems knowledge
• Data integrity and documentation discipline
• Change control and CAPA management

Education

• Bachelor’s degree in Life Sciences or related field required (e.g., Immunology, Microbiology, Cell Biology, Engineering).

Additional Requirements

• Environment involves office and cleanroom settings; must comply with gowning requirements and be able to remain stationary during processing as needed.
• Ability to move within cleanroom environments to oversee tasks; exposure to compressed gasses and LN2; handling human tissue or cellular materials as part of manufacturing operations.
• Remote-eligible work arrangement with potential on-site requirements at CMOs and travel up to 50% as needed.