Analytical Science and Technology Principal Scientist

Vertex Pharmaceuticals•Boston, MA

5d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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.
Embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends.
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.

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.