Manager, Bioanalytical Regulatory

Role: Senior bioanalytical scientist overseeing multiple CRO bioanalytical functions supporting neuropharmacology programs. Objectives: ensure development, validation, and transfer of regulated (GLP/GCP) bioanalytical methods for pharmacokinetics, biomarker, and immunogenicity studies; serve as SME and mentor within preclinical and clinical teams. Responsibilities: manage CRO relationships, oversee method transfer/validation, review study protocols/regulatory documents, lead project teams, and contribute to regulatory filings. Qualifications: BS/BA with 8+ years, MS with 6+ years, or PhD with 3+ years in chemistry, biology, or related; extensive hands-on experience with LC-MS/MS, enzyme/immune assays, and regulated bioanalysis; expert knowledge of GLP guidance, bioanalytical techniques, and regulatory standards; proven leadership and project management skills. HighValue: bioanalysis in neuropharma, non-GLP/GLP environments, supporting DMPK and biomarker studies, with advanced mass spectrometry expertise, regulatory interaction, and CRO oversight. WorkSetup: primarily onsite with leadership responsibilities; no explicit travel specified.