Analytical Development Principal Scientist, Microbiology & Viral Safety

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 patients.

Pay Range:

$140,800 - $211,200

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:

On-Site Designated

Flex Eligibility Status:

In this On-Site designated role, you will 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-Onsite

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 person's 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 ApplicationAssistance@vrtx.com