Director, MSAT (Drug Substance/Drug Product)

Vertex Pharmaceuticals

  • Boston, MA
  • Permanent
  • Full-time
  • 1 month ago
Job DescriptionThe Director, Manufacturing Science and Technology (MSAT) – Drug Substance / Drug Product is a key leadership role within the Commercial Manufacturing and Supply Chain (CMSC) organization and will be responsible for leading technical programs within the Vertex Cell and Gene Therapy (VCGT) manufacturing network. The role, based at the Boston Seaport site, will manage a team of DS/DP experts supporting commercialization of Vertex’s portfolio. This key leadership position will play a critical role in bringing novel processes from clinical development and manufacturing into a commercial manufacturing setting, in preparation for commercial launch and routine supply.Key Responsibilities:
  • Manage and develop a high performing team with focus on team diversity, engagement, and professional development.
  • Collaborate across functions to create and drive execution of the Type 1 Diabetes (T1D) technical agenda, which details the projects and process development / improvements required to achieve strategic goals.
  • Support the establishment of network strategies for drug substance / drug product manufacturing, critical components, and testing.
  • Be an effective change agent and champion for continuous improvement and technical innovation within the VCGT network.
  • Collaborate with risk management and program management functions to articulate technical risks and develop / manage mitigations.
  • Liaise with tech leads from other programs to build collective cell and gene therapy knowledge.
  • Engage across the industry to identify best practices and improvement opportunities.
Minimal Requirements:
  • Requires at least 10 years of relevant experience in the biopharmaceutical industry or the equivalent combination of education and experience.
  • Advanced degree (MS/ Ph.D./ Eng Doc) in Science/Engineering or equivalent is essential.
  • Advanced experience in a key technical leadership/management role in pharmaceutical development, cell and gene therapy, and manufacturing
  • Previous leadership experience working in a highly matrixed environment
  • Extensive experience with biologics process development and cGMP manufacturing
  • Experience with cGMP regulations/guidance and regulatory agency inspections.
  • Experience authoring/reviewing CMC product submissions and post-approval changes
  • Experience working with external manufacturing partners (CMOs), suppliers and service providers.
  • Ability to travel, nationally and internationally, up to 10 - 15%.
  • Flexibility to work on site a minimum of 3 days per week.
Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases.Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and commercial offices in the United States, Europe, Canada and Australia. For four years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the company, please visit .Company InformationVertex 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.

Vertex Pharmaceuticals