External Manufacturing Associate Director

Location: London, UK or Maastricht, Netherlands

Looking for opportunities with purpose, impact and possibilities? Our client, Vertex, is a global biotechnology company that invests in scientific innovation. As they grow their pipeline at pace, they are strengthening their reputation for creating transformative medicines for people with serious diseases.

The primary focus of the External Manufacturing Associate Director 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 located either at the cell and gene therapy CMO’s site and/or be able to travel up to 50% of their time to those 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 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.
• Work closely with CMO and internal Quality and Technical teams to prioritize, monitor, track, review and deliver required compliance documentation.
• 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.
• Maintain on-site presence at CMO facilities for extended periods to oversee critical program activities.
• 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.
• Identify and escalate business-critical issues to Commercial Manufacturing and Supply Chain, CMC, and Quality 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 applications.

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 CMO’s Cleanroom qualification.

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.

Vertex is partnering with Talent Works to manage their international temporary job openings. If you are successful in your application, you will be employed by Talent Works to work on a temporary assignment at Vertex.