Senior Scientist, Analytical Development

Role: Senior Scientist in Analytical Development focused on cell-based assays for gene therapy products. Objectives: develop, optimize, transfer, and qualify assays (potency, immunogenicity) supporting drug approval and stability. Responsibilities: lead a team for assay lifecycle management, including cell line qualification, assay validation, and data trending; oversee technology transfer to collaborators; author regulatory submission sections; ensure compliance with relevant guidelines (ICH, USP, EP, JP). Qualifications: Ph.D. in Biology, Chemistry, or related with 4-8+ years industry experience, or 12-15 years non-PhD; proficiency in mammalian cell culture, flow cytometry, digital PCR, sequencing platforms; experience in assay lifecycle management for cell/gene therapy; knowledge of regulatory guidelines. Preferred: team mentorship, regulatory document authoring, analytical method transfer, risk assessments, cross-functional collaboration. HighValue: cell/gene therapy, potency assays, ex-vivo/in-vivo platforms, regulatory filings, on-site work. The role reports to the Director of Analytical Development and involves working closely with internal teams and external contract labs.