Senior Scientist, Biologics Drug Substance Commercialization Process Analytics

Role: Senior Scientist in Process Analytics supporting biologics pipeline development and lifecycle activities. Objectives: provide scientific leadership, optimize analytical methods, ensure technical readiness, and support process development and commercialization of biologics. Responsibilities: guide routine testing, troubleshoot analytical issues, collaborate with process teams, establish new methods, author regulatory documents, and promote scientific rigor and compliance. Qualifications: PhD in Chemical Engineering, Bioengineering, or related, with no minimum experience; or Master's with 4+ years; or Bachelor's with 6+ years industry experience. Skills: strong analytical background, troubleshooting, cross-functional collaboration, data analysis, and scientific communication. Preferred: experience with HPLC/UPLC, capillary electrophoresis, ELISA, PCR, and biopharmaceutical quality attributes; knowledge of cGMP, process development, and analytical method qualification; experience with biologics process development and electronic lab systems. High-value biopharma specifics: biologics, process development, analytical method transfer, lifecycle support, regulatory documentation, and technical leadership in a research-intensive environment. Work setup: not specified, but implied to be within a collaborative research or laboratory setting; travel not required. Focus areas include analytical sciences, biologics process support, and lifecycle management for therapeutic proteins.