External Manufacturing Associate Director

External Manufacturing Operations 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 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:** 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.Work closely with CMO and internal Quality and Technical teams to prioritize, monitor, track, review 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.**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.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 changeAbility to travel, national and international, up to 50%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’sOffice and cleanroom – must be able to comply with cleanroom gowning requirements at CMOMust be comfortable moving about inside the cleanroom to oversee process tasks The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.

From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.In this Remote-Eligible role, you can choose to be designated as:

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**Remote**: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; **or select**

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**Hybrid**: work remotely up to two days per week; **or select**

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**On-Site**: work five days per week on-site with ad hoc flexibility. #J-18808-Ljbffr