External Manufacturing Associate Director (Person In Plant) in City of Westminster

General Summary: The primary focus of the Associate Director, External Manufacturing role is to oversee Vertex’s critical cell and gene therapy Contract Manufacturing Organizations (CMOs) and implement our vision for this business-critical function. We are looking for a candidate with the breadth of professional experience and the drive to work with both internal and external partners to define and manage the ongoing cGMP supply of cell and gene therapy products from clinical through post-approval lifecycle management. The right candidate should have the ability to understand the challenges and make proactive decisions after anticipating cross-functional and patient impact. The successful candidate should have a strong operational, quality, compliance and technical background, with proven project management and supplier management abilities. The candidate will be able to travel up to 50% of their time to the CMO sites as a “Person-in-Plant” to oversee activities on the ground, and/or as a SME to provide technical support to resolve emerging issues. The successful candidate will be a key member of the Vertex/CMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities.

Key Duties and Responsibilities:

• Function as the first/primary point of contact for all Vertex interests/activities at ATMP cell and gene therapy Contract Manufacturing Organizations (CMOs).
• Provide operational oversight of, and troubleshooting support to, CMOs to ensure all deliverables meet or exceed Vertex and regulatory requirements.
• Become an advocate for the CMO, facilitating issue resolution as needed, by bridging internal and external teams.
• Proactively “connect the dots” on emerging trends and issues and lead/influence cross functional teams to drive resolutions and minimize impact to compliance and delivery of safe and reliable supply.
• Maintain on-site presence at CMO facilities for extended periods to oversee critical program activities, clinical and commercial batch manufacturing, and Health Authority inspections.
• Leverage Technical, Quality and Regulatory SMEs to provide guidance to CMOs and ensure cross-functional alignment on program priorities and deliverables.
• Liaise closely with internal and CMO stakeholders and leadership to drive Vertex business operations priorities.
• Manage and track CMO performance prior to, during, and after manufacturing.
• Manage and track batch data in appropriately compliant systems to support filing submissions, patient planning and process optimization.
• Work closely with CMO and internal Quality and Technical teams to prioritize, monitor, track, review, approve and deliver required compliance documentation.
• Identify and escalate business-critical issues to relevant leadership.
• Collaborate with CMO and internal stakeholders to understand planned changes and manage the end-to-end implementation of agreed changes.
• Lead continuous improvement initiatives to affect timely resolution of supply issues.
• Build and maintain strategic relationships within the CMO organization as well as key internal stakeholders.
• Other duties and projects as assigned to meet departmental or company goals.

Minimum Requirements:

• Bachelor's degree required, ideally in cell biology, or closely related in Life Sciences disciplines with 10+ years of relevant experience in biotech or pharmaceutical industries.
• Strong quality and compliance background in a commercial GMP biopharmaceutical operations environment.
• Strong technical background in aseptic manufacturing operations.
• Solid project management skills and experience managing complex projects.
• Strong verbal and written communication skills.
• Strong leadership and an innate ability to collaborate and build relationships.
• Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change.
• Flexibility to work shift hours required to cover critical process steps.
• Ability to travel, national and international, up to 50%.
• Excellent computer skills including Microsoft Office and electronic quality systems.

Desired Additional Skills:

• Strong technical background in cell and genetic therapy related manufacturing operations.
• Solid experience in equipment and facility qualification and validation for ATMP CMOs.
• Cleanroom qualification history.

Environment:

• Office and cleanroom – must be able to comply with cleanroom gowning requirements at CMO.
• Must be able to remain in a stationary position 50% during cleanroom processing activities.
• Must be comfortable moving about inside the cleanroom to oversee process tasks.
• Compressed gasses and LN2 are commonly used in manufacturing operations.
• Human tissue and cellular materials are commonly used.

Flex Designation: Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as Hybrid or On-Site.