Manufacturing Science and Technology Principal Scientist - Material Science
Vertex Pharmaceuticals
- Boston, MA
- Permanent
- Full-time
- Represent the MSAT function in cross-functional teams as a materials science technical subject matter expert for single-use systems, cell culture media, and/or small/large molecule raw materials.
- Support and champion continuous improvement and technical innovation within the VCGT network with respect to raw materials.
- Establish procedures and business processes to conduct raw material technical assessments, support onboarding new materials and technologies, alternate material sources, as well as supplier-initiated material change notifications.
- Collaborate with risk management and program management functions to articulate technical risks and develop/manage mitigations.
- Liaise with technical leads from other programs and functions to build collective cell and gene therapy knowledge.
- Engage industry to identify best practices and improvement opportunities.
- Requires at least 4 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
- Deep knowledge of cell culture media formulations and manufacturing, single-use-systems, and small/large molecule materials.
- Previous 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 with continuous improvement, proficiency with operational excellence preferred.
- 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