Analytical Science and Technology Principal Scientist

Role: Principal Scientist, Microbiology at Vertex supporting biologics, cell therapy, and gene therapy programs. Responsibilities: lead microbiology method qualification, validation, lifecycle management, and develop microbial control strategies; oversee investigations, root cause analyses, deviations, CAPAs, and compliance; manage microbiology testing at contractors and support regulatory submissions, inspections, and audits. Requirements: PhD in Microbiology, Biology, or related field with 5+ years (PhD), 8+ years (MS), or 10+ years (BS) of industry experience; deep expertise in pharmaceutical microbiology, microbial control, GxP environments, and regulatory requirements; experience with biologics and cell/gene therapies, late-stage development, and manufacturing support preferred. HighValue: biologics, cell therapy, gene therapy, microbiology lifecycle management, microbiology method development and validation, regulatory support, contract organization oversight. WorkSetup: hybrid or on-site; flexible scheduling.