Analytical Science and Technology Principal Scientist

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:

Disclosure Statement:

Flex Designation:

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 Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at