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 based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
