Analytical Science and Technology Principal Scientist

Vertex Pharmaceuticals LLC; 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

General Summary:

Vertex Pharmaceuticals is seeking a Principal Scientist, Microbiology to join the Analytical Science & Technology (AS&T) organization supporting biologics, cell therapy, and gene therapy programs. This role serves as the microbiology technical leader and subject matter expert responsible for microbiological methods and microbial control strategies supporting late-stage development and commercial products. The successful candidate will provide scientific leadership across microbiology method lifecycle management, external laboratory oversight, investigations, compliance, and continuous improvement to ensure robust, inspection-ready testing throughout the global network.

Key Duties and Responsibilities:

• Lead microbiology method qualification, validation, transfer, implementation, monitoring, and lifecycle management activities supporting biologics, cell therapy, and gene therapy products.
• Serve as the microbiology subject matter expert for sterility, rapid microbiological methods, bioburden, endotoxin, microbial identification, growth-promotion testing, and other product- or process-specific methodologies.
• Develop and maintain scientifically sound, risk-based microbial control strategies throughout the product lifecycle.
• Lead complex microbiology investigations, root cause analyses, deviations, CAPAs, and compliance risk assessments.
• Provide technical leadership for microbiology-related change controls, comparability assessments, specifications, technical assessments, procedures, protocols, reports, and method performance trending activities.
• Oversee microbiology testing and analytical performance at contract laboratories and contract development and manufacturing organizations, including technical transfer, issue resolution, data review, and continuous improvement initiatives.
• Support regulatory submissions, health authority responses, inspections, audits, and inspection-readiness activities related to microbiology programs.
• Collaborate with Regulatory CMC, Quality, Manufacturing, Supply Chain, Process Development, Analytical Development, and external partners to support commercialization and lifecycle management activities.
• Drive execution of program commitments through effective prioritization, risk management, and delivery of high-quality technical and compliance deliverables.
• Provide technical leadership, mentoring, and coaching to scientists and technical team members while strengthening microbiology capability and operational excellence across the organization.

Knowledge and Skills:

• Deep expertise in pharmaceutical microbiology and microbial control strategies supporting biologics and/or cell and gene therapy products.
• Demonstrated experience with microbiology method development, validation, transfer, implementation, monitoring, and lifecycle management in GxP environments.
• Strong knowledge of sterility, bioburden, endotoxin, microbial identification, rapid microbiological methods, and growth-promotion testing.
• Thorough understanding of current Good Manufacturing Practice requirements, global regulations, pharmacopeial expectations, and commercial-stage microbiology and CMC requirements.
• Proven ability to lead investigations, risk assessments, CAPAs, change controls, and technical impact assessments.
• Experience overseeing contract laboratories, contract development and manufacturing organizations, and external partners supporting microbiology testing and technical transfer activities.
• Experience supporting regulatory submissions, inspection readiness, regulatory inspections, audits, and health authority interactions.
• Strong technical writing, data analysis, communication, collaboration, and influencing skills.
• Ability to manage competing priorities and operate effectively in a fast-paced, matrixed environment while maintaining scientific rigor and compliance.

Education and Experience:

PhD in Microbiology, Biology, Biochemistry, Biotechnology, or a related scientific discipline with 5+ years of relevant industry experience; MS with 8+ years; or BS with 10+ years. An equivalent combination of education and experience may be considered. Experience supporting biologics and/or cell and gene therapy products through late-stage development, commercialization, microbiology lifecycle management, contract testing oversight, or manufacturing support is preferred. Experience supporting commercial manufacturing, regulatory submissions, inspection readiness, and health authority interactions is highly desirable.

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range:

$138,400 - $207,600

Disclosure Statement:

The range provided is base