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 Masters and 7 years or Bachelors 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:

Disclosure Statement:

Flex Designation:

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 Vertexs 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 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