Associate Principal Scientist, Biologics Analytical R&D

Role: Associate Principal Scientist in Biologics Analytical R&D focusing on developing, qualifying, and troubleshooting analytical methods for monoclonal and complex therapeutic proteins. Responsibilities: design and transfer assays such as chromatography, CE, immunoassays; lead experimental design, data interpretation, and technical leadership; author technical reports and support regulatory filings (IND, BLA); collaborate cross-functionally; oversee project execution and method validation in regulated environments. Qualifications: B.S. with 10+ years, MS with 7+ years, or Ph.D. with 3+ years in Chemistry, Biochemistry, or related; expertise in separation sciences (HPLC, SEC, IEX, HILIC), electrophoresis, immunoassays (ELISA, qPCR); experience with assay qualification, validation, and transfer; strong communication, scientific leadership, and collaborative skills. Preferred: experience with statistical analysis (JMP, Minitab), biologics modalities (mAbs, ADCs, fusion proteins), charge/size variants, glycans; understanding of degradation mechanisms and orthogonal analyses; GxP compliance. High-value biopharma specifics: focus on biologics, clinical stage (supporting clinical trial material), regulated environments, and assay development for complex proteins. Collaboration with cross-functional teams, with no travel required. Location: Rahway, NJ, on-site.