Analytical Science and Technology Principal Scientist

Vertex Pharmaceuticals seeks a Principal Scientist in Microbiology to lead analytical science and technology efforts for biologics, cell therapy, and gene therapy programs. The role focuses on microbiology method lifecycle management, regulatory compliance, external laboratory oversight, and investigations to support late-stage development and commercial products.

Responsibilities

• Lead microbiology method qualification, validation, transfer, implementation, and lifecycle management for multiple product lines
• Develop and maintain risk-based microbial control strategies throughout product lifecycle
• Oversee microbiology testing performance at contract laboratories and external manufacturing organizations
• Lead complex investigations, root cause analyses, and compliance risk assessments related to microbiology
• Support regulatory submissions, health authority responses, and inspection-readiness activities

Requirements

• PhD in Microbiology, Biology, Biochemistry, or related discipline with 5+ years industry experience
• Deep expertise in pharmaceutical microbiology and microbial control strategies for biologics or cell/gene therapies
• Demonstrated experience with method development, validation, transfer, and lifecycle management in GxP environments
• Strong knowledge of sterility, bioburden, endotoxin, microbial identification, and rapid microbiological methods
• Proven ability to lead investigations, risk assessments, CAPAs, and change controls
• Experience overseeing contract laboratories and external partners for microbiology testing
• Knowledge of cGMP requirements, global regulations, and pharmacopeial expectations

Compensation: $138,400 - $207,600 base