Lead Scientist, Microbiology & Viral Safety - Analytical Dev

Vertex Pharmaceuticals; Boston (MA); On-site; USD 141,000 - 211,000; Full time

Benefits offered by this job

Medical benefits

Dental & Vision coverage

Commuting subsidy

Annual bonus

Job summary

Vertex Pharmaceuticals seeks a Principal Scientist, Analytical Development – Microbiology & Viral Safety, to lead microbiology and viral safety testing across development programs. You will serve as SME for assay selection, development, qualification, validation, and lifecycle management, guiding cross-functional teams and regulatory interactions.

The role emphasizes rapid method innovation, risk assessment expertise, and collaboration with internal and external partners to ensure regulatory

Qualifications

• Advanced degree in Microbiology or Virology with relevant industry experience.
• Experience supporting regulatory submissions and health authority interactions.
• Strong cross-functional collaboration and scientific communication skills.

Responsibilities

• Serve as SME for microbiology and viral safety assays and lead strategy across programs.
• Develop/validate/transfer microbiological assays and rapid methods; lifecycle management.
• Provide guidance on risk assessment, assay selection, testing strategies, and regulatory milestones.
• Prepare technical dossiers, validation plans, and reports for regulatory submissions and inspections.
• Lead wet-lab development and collaborate with external testing labs as needed.
• Represent the organization in scientific forums and consortia to advance best practices.

Skills

Microbiology & Virology expertise

Regulatory submissions

Cross-functional collaboration

Communication skills

GMP experience

ATMP knowledge

Adventitious agent safety

Education

PhD in Microbiology

MS with significant experience

BS with extensive experience

Job description

Vertex Pharmaceuticals seeks a Principal Scientist, Analytical Development – Microbiology & Viral Safety, to lead microbiology and viral safety testing across development programs. You will serve as SME for assay selection, development, qualification, validation, and lifecycle management, guiding cross-functional teams and regulatory interactions.

The role emphasizes rapid method innovation, risk assessment expertise, and collaboration with internal and external partners to ensure regulatory