Job Description
We are seeking a highly skilled Principal Scientist, Analytical Development – Microbiology & Viral Safety to provide strategic and technical leadership for microbiology and viral safety testing across multiple development programs. This role will serve as the subject matter expert for microbiological and virological assays, supporting control strategy development, process development, regulatory submissions, and commercial readiness.
The ideal candidate will bring deep expertise in microbiological and virological risk assessment, as well as assay evaluation, development, qualification, validation, and lifecycle management. This individual will also demonstrate strong cross-functional collaboration skills and a passion for scientific innovation.
Key Duties and Responsibilities:
Serve as the primary subject matter expert for microbiology and viral safety assays across cell and gene therapy and biologics programs, providing strategic and technical leadership to support development, manufacturing, and regulatory objectives
Lead the development, qualification, validation, transfer, implementation, and lifecycle management of microbiological assays, including mycoplasma, sterility, Gram stain, and endotoxin methods, as well as viral safety assays
Provide technical guidance to cross-functional teams on microbiological and virological risk assessment, assay selection, and testing strategies to support product development, process changes, investigations, and regulatory milestones
Author and review technical dossiers, validation plans, protocols, reports, and scientific justifications to support regulatory submissions, health authority interactions, and inspection readiness
Drive innovation in rapid and alternative microbiological methods to improve testing efficiency, strengthen manufacturing support, and enable scalable solutions for clinical and commercial programs
Lead the evaluation, development, validation, transfer, and implementation of rapid and alternative microbiological methods in collaboration with internal stakeholders and external testing laboratories
Represent the organization in external scientific forums, industry consortia, and collaborative initiatives to strengthen internal capabilities and advance best practices in adventitious agent safety
Lead wet lab development activities, including hands-on experimental work
Knowledge and Skills:
Strong expertise in microbiology, virology, and adventitious agent safety
Strong knowledge of regulatory expectations for microbiological and viral safety testing for clinical and commercial products
Experience supporting regulatory submissions, inspections, and health authority interactions
Demonstrated ability to work effectively across cross-functional teams and with external partners
Strong written, verbal, and scientific communication skills
Experience in cell and gene therapy, biologics, or advanced therapy medicinal products (ATMPs)
Familiarity with rapid and alternative microbiological methods and implementation strategies
Participation in industry working groups, scientific forums, or consortia.
Strong understanding of GMP environments and manufacturing support requirements
Education and Experience:
Advanced degree in Microbiology, Virology, Biological Sciences, Pharmaceutical Sciences, or a related field; PhD preferred, with MS candidates considered based on significant relevant experience
PhD and 4+ years, or Master's and 7+ years , or Bachelor's and 10+ years
Significant industry experience in assay development, qualification, validation, transfer, and lifecycle management
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…