Principal Microbiology Scientist, Biologics & Gene Therapy

Vertex Pharmaceuticals Inc (US); Boston (MA); Hybrid; USD 138,000 - 208,000; Full time

Job summary

Vertex Pharmaceuticals Inc is seeking a senior microbiology leader to guide qualification, validation, transfer, and lifecycle management for biologics, cell, and gene therapies. You will act as the microbiology SME for sterility and related methods, and drive risk-based microbial control strategies across the product lifecycle.

The role includes leading complex investigations, CAPAs, and technical change controls, while coordinating with Regulatory CMC, Quality, Manufacturing, and external

Qualifications

• Pharmaceutical microbiology expertise with lifecycle management in GxP environments.
• Experience leading investigations, CAPAs, change controls and risk assessments.
• Experience overseeing contract laboratories and external partners.

Responsibilities

• Lead microbiology qualification, validation, transfer and lifecycle management for biologics/cell/gene therapy products.
• Serve as SME for sterility, bioburden, endotoxin, and rapid microbiological methods.
• Develop risk-based microbial control strategies across product lifecycle.
• Lead investigations, root cause analyses, deviations, CAPAs and risk assessments.
• Provide leadership for change controls, specifications, reports and data trending.
• Oversee testing at contract labs/CDMOs, including data review and transfers.

Skills

Pharmaceutical microbiology

Sterility testing

Bioburden testing

Endotoxin testing

Method development

Technical leadership

CMC collaboration

Education

PhD in Microbiology

MS in Microbiology

BS in Biology

Job description

Vertex Pharmaceuticals Inc is seeking a senior microbiology leader to guide qualification, validation, transfer, and lifecycle management for biologics, cell, and gene therapies. You will act as the microbiology SME for sterility and related methods, and drive risk-based microbial control strategies across the product lifecycle.

The role includes leading complex investigations, CAPAs, and technical change controls, while coordinating with Regulatory CMC, Quality, Manufacturing, and external