Senior Specialist II, Quality Control Validation

Role: Senior Specialist II, QC Validation, overseeing method validation and validation readiness within Quality Control for cell and gene therapy manufacturing. Responsibilities: develop validation strategies, protocols, and plans aligned with regulatory standards; execute validation activities; analyze data; ensure compliance; collaborate with Analytical Development, QC testing, QA, and customer teams; support inspections and audits; mentor supporting staff. Qualifications: BS in Biology, Molecular Biology, Chemistry, or related field with 8+ years (or MS with 6+ years) in GMP QC; expertise in gene and cell therapy assays like qPCR, ddPCR, flow cytometry, ELISA, cell-based assays; strong GMP, SOP, and quality system knowledge; data analysis skills; experience with method validation for commercial products; preferred experience in cell/gene therapy manufacturing and electronic systems (LIMS, QMS). HighValue: cell and gene therapy, validation, GMP QC, microbiology, raw materials, outsourcing, regulatory compliance. WorkSetup: not specified; physical requirements include standing and routine movements.