Senior Manager, Analytical Method Validation

Role: Lead analytical method validation within the Quality Control department for oligonucleotide drug substances and products, ensuring regulatory compliance and method robustness. Responsibilities: plan, execute, and oversee validation and technical transfer activities; serve as SME in analytical techniques (LCMS, HPLC, GC, NMR, FTIR); support method optimization, troubleshooting, and data analysis; collaborate with internal teams and external partners; ensure documentation compliance; evaluate new analytical technologies. Requirements: MS in Chemistry with 6+ years (or BS with 8+ years) laboratory experience; expertise in complex oligonucleotide analytics, validation, and transfer; experience in GMP-regulated environments and supporting regulatory inspections; strong leadership, organization, and technical skills; proficiency in chromatography data systems and knowledge of ICH and USP guidelines. Preferred: experience with analytical tech support for API and drug product, and supporting regulatory interactions. High-Value: focus on oligonucleotide therapeutics, analytical validation, GMP compliance, and cross-site technical transfer. WorkSetup: not specified; likely on-site or hybrid based on company norms.