Lead Microbiology Scientist - Biologics & Gene Therapy

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

Job summary

Vertex Pharmaceuticals is seeking a Principal Scientist, Microbiology to lead microbiology methods for biologics, cell therapy, and gene therapy programs. You will oversee method development, validation, transfer, and lifecycle management across a global network, with external lab oversight and regulatory readiness.

The role requires deep GMP microbiology expertise, strong collaboration across functions, and delivery of high-quality compliance deliverables.

Qualifications

• PhD/MS/BS with corresponding industry experience in biologics, cell therapy, or gene therapy microbiology.
• Experience leading microbiology method lifecycle management in GxP environments.
• Experience supporting regulatory submissions and health authority interactions.

Responsibilities

• Lead microbiology method qualification, validation, transfer, implementation, monitoring, and lifecycle management for biologics, cell therapy, and gene therapy products.
• Serve as SME for sterility, bioburden, endotoxin, microbial identification, rapid methods, and growth-promotion testing.
• Develop and maintain risk-based microbial control strategies across product lifecycles.

Skills

Microbiology leadership

GxP microbiology

Method development

Regulatory submissions

Data analysis

Project management

Cross-functional collaboration

Education

PhD in Microbiology or related

MS in related field

BS in related field

Tools

Contract laboratory oversight

Job description

Vertex Pharmaceuticals is seeking a Principal Scientist, Microbiology to lead microbiology methods for biologics, cell therapy, and gene therapy programs. You will oversee method development, validation, transfer, and lifecycle management across a global network, with external lab oversight and regulatory readiness.

The role requires deep GMP microbiology expertise, strong collaboration across functions, and delivery of high-quality compliance deliverables.