Director, MSAT (Drug Substance/Drug Product)
Vertex Pharmaceuticals
- Boston, MA
- Permanent
- Full-time
- 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.
- 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.