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Senior Director of External Manufacturing

1 month ago

London, Greater London, United Kingdom Vertex Pharmaceuticals Full time
Job Summary

The Senior Director of External Manufacturing will play a critical role in managing Vertex-CDMO partnerships to ensure the effective and efficient delivery of CGT medicines to patients. This role will engage directly with internal functional areas to ensure KPIs and information needs are understood and met.

Key Responsibilities
  • Manage Vertex-CDMO partnerships to ensure seamless supply of ex-US clinical and commercial CGT products.
  • Partner with internal stakeholders to develop and implement CGT manufacturing, supply, logistics, and commercialization strategies.
  • Identify opportunities for continuous improvement of CDMO throughput, robustness, data-management, etc without disrupting day-to-day operations.
  • Responsible for identifying business risks through the manufacturing value chain, working proactively with relevant stakeholders to negotiate mitigations, manage these risks, and assure supply continuity for delivery against commitments.
  • Track and communicate execution of the production plan at CGT CDMOs, with appropriate escalation of impactful quality or operational deviations/excursions impacting planned production.
Requirements
  • Significant years of progressive experience in key leadership/management roles in biologics or CGT therapy development, clinical and commercial manufacturing, and commercialization.
  • Strong understanding of the technical aspects of manufacturing, testing, controls, and the regulations governing ATMP operations.
  • Strong understanding of financial and supply chain systems in CGT operations.
  • Proven years of experience as main point of contact for commercial strategy and business operations.
  • Able to travel, national and international, up to 20% of time.
Education
  • Bachelor's degree in Life Sciences discipline appropriate to cell and gene therapy programs (immunology, cell biology, genetic engineering, etc).
  • MBA with technology or commercial asset management.

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.