Gene Editing External Manufacturing Operations, Associate Director at Vertex Pharmaceuticals in Paddington

Job description

Job Description Associate Director, Cell & Gene Therapies External Manufacturing Operations – Commercial Manufacturing & Supply Chain, Vertex Pharmaceuticals 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: 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. 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. 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 complian