Senior Microbiology Scientist, Biologics & Gene Therapy

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

Benefits offered by this job

Hybrid work

On-site option

Total Rewards program

Educational assistance

Job summary

Vertex Pharmaceuticals is seeking a Principal Scientist, Microbiology to lead microbiology method lifecycle management across biologics, cell therapy, and gene therapy programs. You will oversee external labs, investigations, CAPAs, and regulatory interactions to ensure inspection-ready testing globally.

The role requires deep pharma microbiology expertise, demonstrated leadership, and collaboration with CMC, QA, Manufacturing, and Regulatory teams to drive compliant, high-quality deliverables

Qualifications

• PhD in Microbiology or related scientific discipline with 5+ years of industry experience.
• MS with 8+ years; or BS with 10+ years; equivalent experience considered.
• Experience supporting biologics and/or cell and gene therapy products through late-stage development.

Responsibilities

• Lead microbiology method qualification, validation, transfer, implementation, monitoring, and lifecycle management.
• Spearhead sterility, bioburden, endotoxin, microbial identification, rapid microbiological methods, and related methodologies.
• Develop and maintain scientifically sound microbial control strategies across product lifecycle.
• Lead complex microbiology investigations, root cause analyses, deviations, CAPAs, and risk assessments.
• Oversee testing at contract labs and CDMOs, including tech transfer and issue resolution.
• Support regulatory submissions, health authority responses, inspections, and audit readiness.
• Collaborate across Regulatory CMC, Quality, Manufacturing, Supply Chain, and external partners.
• Drive prioritization, risk management, and delivery of high-quality technical and compliance deliverables.
• Provide mentoring and coaching to scientists to strengthen microbiology capability.

Skills

Microbiology expertise

Method lifecycle Mgmt

Technical leadership

Regulatory submissions support

Data analysis & writing

Education

PhD in Microbiology

MS in related field

BS in related field

Job description

Vertex Pharmaceuticals is seeking a Principal Scientist, Microbiology to lead microbiology method lifecycle management across biologics, cell therapy, and gene therapy programs. You will oversee external labs, investigations, CAPAs, and regulatory interactions to ensure inspection-ready testing globally.

The role requires deep pharma microbiology expertise, demonstrated leadership, and collaboration with CMC, QA, Manufacturing, and Regulatory teams to drive compliant, high-quality deliverables