Analytical Development Principal Scientist, Microbiology & Viral Safety

Role: Principal Scientist, Analytical Development – Microbiology & Viral Safety, providing strategic leadership in microbiological and virological testing for cell and gene therapy, biologics, and advanced therapies. Responsibilities include developing, qualifying, validating, transferring, and managing microbiological and viral safety assays, supporting process development, regulatory submissions, and manufacturing. The role involves authoring technical documents, guiding risk assessments, and driving innovation with rapid microbiological methods. Collaboration spans cross-functional teams and external partners, with emphasis on regulatory compliance, especially GMP and health authority interactions. The position requires hands-on wet lab work and representation in scientific forums. Qualifications: PhD in Microbiology, Virology, or related field with 4+ years (PhD) or 7+ years (MS) or 10+ years (BS) of industry experience in assay development, validation, and lifecycle management. Skills in assay evaluation, regulatory standards, and experience supporting regulatory inspections are essential. Preferred expertise includes cell and gene therapy, biologics, adventitious agent safety, and familiarity with rapid testing strategies. Work setup: On-site, five days/week, with ad hoc flexibility; travel details are not specified.