Senior Scientist, Analytical Development - Small Molecule

Role

Senior Scientist, Analytical Development, leading analytical efforts for small-molecule drug substances and products across early to late development stages.

Responsibilities

develop, 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.

Requirements

Bachelor’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.

Preferred

experience with inhalation and combination products.

High Value

small molecule drug development, CMC, regulatory submissions, GMP testing, in-person work at Bridgewater, NJ, minimal travel.