External Manufacturing Associate Director (Person In Plant)

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 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 (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 CMO for right-first-time execution of commercial operations.

• 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 (including off-hours/weekends) to oversee (i) critical program activities, (ii) clinical and commercial batch manufacturing until the CMO is sustainably executing operations, and (iii) Health Authority inspections. 

• Leverage Technical, Quality and Regulatory SMEs to provide guidance to CMOs and ensure cross-functional alignment on program priorities and deliverables from clinical through commercial manufacturing and supply.  This includes working closely with CMO and internal stakeholders on preparations for pre-approval inspection and commercialization/launch-readiness.

• Liaise closely with internal and CMO stakeholders and leadership to drive Vertex business operations priorities including but not limited to (i) contract management (including tracking KPIs and metrics e.g. for batch release, inventory targets and schedule attainment), (ii) forecast communication and schedule alignment, (iii) supplier governance (including Vertex Quality/other audits) and (iii) finance (e.g. issuance of POs and reconciliation/validation of invoices; tracking of spend vs budget).

• Manage and track CMO 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 CMO and internal Quality and Technical teams to prioritize, monitor, track, review, approve and deliver required compliance documentation (including but not limited to change controls, investigations and deviations, batch data, CAPA effectiveness, internal/external audit observation deadlines, regulatory commitments) to meet Vertex program requirements.

• Identify and escalate business-critical issues to Commercial Manufacturing and Technical Operations CMTO), Supply Chain, CMC-Regulatory, and Quality leadership.

• Collaborate with CMO 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.

• 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.  

• Live the Vertex values

Minimum Requirements: 

• Bachelor's degree required, ideally in cell biology, or closely related in Life Sciences disciplines (Immunology, Microbiology, Cell Biology, Engineering, etc.) with 10+ years of relevant experience in biotech or pharmaceutical industries, ideally in a senior manufacturing/operations leadership role working with or in cGMP facilities within the biotechnology industry.

• 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 express 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

• Flexibility to work shift hours required to cover critical process steps

• Ability to travel, national and international, up to 50%

• Represent Vertex as a leader

• Excellent computer skills including Microsoft (Word, Excel, Project, Outlook, Teams), equipment interfaces and electronic quality systems

Desired Additional Skills:

• 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 CMO’s

• Cleanroom qualification (Grade A/B) 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 (e.g. apheresis) and cellular materials are commonly used

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]