Principal Scientist, QC Analytical, Cell Therapy

Role: Principal Scientist specializing in QC analytical methods for cell therapy products, leading method transfer, validation, and routine testing of in-process, final, and stability samples. Responsibilities: serve as SME in cell-based assays, ELISA, qPCR, flow cytometry; develop, write, and execute analytical methods and regulatory documents; mentor team members; represent QC in product review boards, regulatory inspections, and audits; lead complex projects, CAPAs, deviations, and continuous improvements; review investigations and own APQR sections; collaborate cross-functionally. Requirements: Bachelor’s in science with 10+ years in analytical testing, including 2+ years QC experience; deep expertise in bioanalytical techniques; advanced technical writing, troubleshooting, and problem-solving skills; strong understanding of global cGMP/regulatory requirements; leadership and mentoring ability. Preferred: PhD in bioanalytical science; experience in cell therapy, biologics, or related modalities; proven track record with regulatory inspections and validation. HighValue: cell therapy, bioanalytical techniques, method validation, regulatory compliance, cross-functional collaboration, troubleshooting, and continuous improvement in a GxP environment. WorkSetup: not specified.