Analytical Development Principal Scientist, Microbiology & Viral Safety

## Analytical Development Principal Scientist, Microbiology & Viral Safety Apply:
Boston, MA:
Full time:
Posted Today:
REQ-30101
** 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,…