Senior Scientist, Analytical Development - Molecule
Listed on 2026-10-08
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Research/Development
Regulatory Compliance Specialist, Pharmaceutical Science/ Research, Research Scientist
Role
Senior Scientist, Analytical Development, leading analytical efforts for small-molecule drug substances and products across early to late development stages.
Responsibilitiesdevelop, optimize, and validate analytical methods (HPLC, GC, LC-MS, NMR, UV, FTIR), ensure regulatory compliance (ICH, FDA, EMA), oversee method transfer, prepare regulatory documentation (IND, IMPD, NDA/MAA), collaborate with cross-functional teams, manage external vendors, troubleshoot analytical issues, and contribute to CMC operations and stability programs.
RequirementsBachelor’s in chemistry or related field with 6+ years of experience, or Master’s with 4+ years; hands‑on expertise in analytical testing for inhalation, oral, and liquid dosage forms; proficiency in cGxP, CMC, ICH standards; meticulous attention to detail; proficiency in Microsoft Office.
Preferredexperience with inhalation and combination products.
High Valuesmall molecule drug development, CMC, regulatory submissions, GMP testing, in-person work at Bridgewater, NJ, minimal travel.
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