Manufacturing Science & Technology Principal Scientist, Material Science

Role Summary

MSAT Principal Scientist – Materials Science, Vertex Pharmaceuticals (Boston). The Principal Scientist, Manufacturing Science and Technology (MSAT) – Materials Science will support the Biopharmaceutical Science and Manufacturing Organization (BSMO) network by applying a deep understanding of relationships between materials properties, process conditions, and final product quality. The role will have a proven track record of applying in-depth conceptual knowledge of materials science and engineering principles to materials and improved process understanding, with in-depth knowledge of one or more relevant areas applicable to biologics and cell therapies.

Responsibilities

• Represent the MSAT function in cross-functional teams as a materials science SME for single-use systems, cell culture media, cytokines, and/or small/large molecule raw materials.
• Support the development of key quality attributes of critical raw materials used in Vertex's biologics and cell therapy processes.
• Facilitate the use of key quality attributes of critical raw materials for material control and investigations.
• Drive through partnerships within MSAT the use of data analytics for raw material analysis that includes but is not limited to statistical process control / control charts for CoA attributes, correlation between raw material attributes and process performance etc.
• Support drafting material qualification reports with cross functional teams.
• Support procedures and business processes to conduct raw material technical assessments, 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.

Qualifications

• Required: 5-7 years of relevant experience in the biopharmaceutical industry or the equivalent combination of education and experience.
• Preferred: Proficiency with operational excellence.
• Required: Deep knowledge of cell culture media formulations and manufacturing, single-use-systems, and small/large molecule and Cell and Gene Therapy (CGT) materials.
• Required: Previous experience working in a highly matrixed environment.
• Required: Extensive experience with biologics and cell therapy process development, and cGMP manufacturing.
• Required: Experience with cGMP regulations/guidance and regulatory agency inspections.
• Required: Experience with continuous improvement.
• Required: Experience working with external manufacturing partners (CDMOs), suppliers, and service providers.
• Required: Flexibility to work on site a minimum of 3 days per week.

Education

• Preferred: Advanced degree (MS/ Ph.D./ Eng Doc) in Science/Engineering.

Skills

• Materials science and engineering principles related to biologics and cell therapies.
• Data analytics and statistical process control for raw materials.
• Cross-functional collaboration and technical communication.
• Knowledge of cGMP and regulatory expectations for biologics/manufacturing.

Additional Requirements

• Travel: Up to 10% travel expected.
• On-site/Hybrid: Flexibility to work on-site a minimum of 3 days per week.