External Manufacturing Operations Gene Editing Associate Director

Job Description

General Summary:

The primary focus of the Associate Director External Manufacturing role is to oversee Vertex's critical cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs) 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 successful candidate will be a key member of the Vertex/CDMO Virtual Plant Team (VPT) contributing to the broader External Manufacturing group activities.

Key Duties and Responsibilities:

• Developing strong relationships with internal functional leaders, leveraging these relationships for development and alignment of the program objectives
• Building and maintaining strategic and operational relationships with Vertex CMOs
• Identifying and escalating business-critical issues affecting supply and timelines as necessary, providing recommendations, mitigations and potential solutions
• Managing the cross-functional teams, building into a high-functioning team where team members are accountable as both functional as well as program representatives
• Driving delivery of the program objectives against aggressive timelines, including managing risks and issues that arise
• Managing and coordinating post-approval lifecycle strategy implementation for programs, including establishing a robust business continuity program with strategic CMOs
• Function as the first/primary point of contact for all Vertex interests/activities at certain ATMP cell and gene therapy Contract Development and Manufacturing Organizations (CDMOs)
• Provide operational oversight of, and troubleshooting support to, CDMOs to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management) - be Vertex's eyes and ears' at the CDMO for flawless execution of commercial operations
• Maintain on-site presence at certain CDMO facilities for extended periods (including some off-hours/days to resolve urgent issues) during clinical batch manufacturing, Health Authority inspections and other critical activities. It is anticipated that routine Person-in-Plant oversight will decrease over time
• Liaison with internal and CDMO stakeholders and leadership on business operations including but not limited to contract management, forecast communication, compliance and finance (eg. issuance of POs and reconciliation/validation of invoices)
• Leverage Technical, Quality and Regulatory SMEs to provide guidance to CDMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply. This includes working closely with CDMO and internal stakeholders on preparations for pre-approval inspection and commercialization-readiness
• Manage and track CDMO performance prior to (preparation), during (direct oversight) and after (campaign summaries/reports) manufacturing
• Manage and track batch data in appropriately compliant (data-integrity) systems to support filing submissions, patient planning and process optimization
• Work closely with CDMO and internal Quality and Technical teams to prioritize and track efficient documentation (including but not limited to change controls, investigations, and deviations) to meet Vertex program requirements
• Collaborate with CDMO and internal stakeholders to understand planned changes and manage the end-to-end implementation of agreed changes including but not limited to change controls and impact assessments
• Facilitate collation of data to track CDMO performance and compliance on metrics/KPIs including but not limited to contractual agreements, batch release, spend/budget, product quality and supply integrity
• Identify and escalate business-critical issues to Commercial Manufacturing and Supply Chain and Quality leadership
• Lead continuous improvement initiatives to affect timely resolution of supply issues
• Build and maintain strategic relationships within the CDMO organization as well as key internal stakeholders
• Live the Vertex values
• Flexibility to work shift hours required to cover critical process steps
• Ability to travel, national and international, up to 30%
• Represent Vertex as a leader when issues arise

Knowledge and Skills:

• Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations
• Strong technical background in aseptic manufacturing operations
• Solid project management skills and experience managing complex projects
• Strong verbal and written communication skills: ability to expresses oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience
• Strong leadership and an innate ability to collaborate and build relationships is critical
• Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change

Education and Experience:

• Bachelor's degree required, ideally in cell biology, or closely related in Life Sciences disciplines (Immunology, Microbiology, Cell Biology, Engineering, etc.) with 8+ years of relevant experience in biotech or pharmaceutical industries, ideally in a senior manufacturing leadership role working with or in cGMP facilities within the biotechnology industry
• MS/MA degree in Biological Sciences, Chemical Engineering or related discipline and at least 6 years of related and relevant experience
• Strong technical background in cell and genetic therapy related manufacturing operations, ideally autologous cell therapy experience
• Solid experience in equipment and facility qualification and validation for ATMP CDMO's

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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.

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 ApplicationAssistance@vrtx.com