Lead Microbiology Scientist for Biologics & Gene Therapy

Vertex Pharmaceuticals; Boston (MA); On-site; USD 138,000 - 208,000; Full time

Job summary

Vertex Pharmaceuticals seeks a Principal Scientist, Microbiology to lead microbiology methods and control strategies across biologics, cell therapy, and gene therapy programs. You will guide method lifecycle management, external lab oversight, investigations, and compliance to ensure robust testing and inspection readiness in a global network.

The role requires deep GMP microbiology expertise, strong leadership, and collaboration with Regulatory CMC, Quality, Manufacturing, and external partners

Qualifications

• PhD in Microbiology with 5+ years in industry; MS with 8+ years; or BS with 10+ years experience in biologics/microbial testing.
• Experience with sterility, bioburden, endotoxin and microbial identification in biologics or gene therapy contexts.
• Strong knowledge of current Good Manufacturing Practice (GMP) and regulatory expectations.

Responsibilities

• Lead microbiology method qualification, validation, transfer, and lifecycle management for biologics/cell/gene therapy products.
• Serve as microbiology SME for sterility, bioburden, endotoxin, and rapid microbiological methods.
• Develop microbial control strategies across product lifecycle and support continuous improvement.
• Oversee testing at contract labs and external CMOs, including tech transfer and issue resolution.
• Support regulatory submissions, inspections, and health authority interactions.

Skills

Microbiology expertise

GxP experience

Investigations leadership

Education

PhD in Microbiology

MS in related field

BS in related field

Job description

Vertex Pharmaceuticals seeks a Principal Scientist, Microbiology to lead microbiology methods and control strategies across biologics, cell therapy, and gene therapy programs. You will guide method lifecycle management, external lab oversight, investigations, and compliance to ensure robust testing and inspection readiness in a global network.

The role requires deep GMP microbiology expertise, strong leadership, and collaboration with Regulatory CMC, Quality, Manufacturing, and external partners