Scientist, Analytical Development, Small Molecule

Role: Scientist, Analytical Development (Small Molecule) at Insmed, focusing on analytical method development and testing across small molecule candidates from early development through Phase III and commercialization. Responsibilities: perform GMP-compliant routine testing for inhalation, tablet, and oral solutions; validate analytical methods using techniques like HPLC, UPLC, GC, and others; support CMC activities and regulatory filings by preparing technical documentation; lead pre-formulation and stability studies; analyze complex data to troubleshoot issues and propose solutions; ensure compliance with GMP, ICH, and pharmacopeial standards. Requirements: Bachelor’s degree in Chemistry with 5+ years’ experience in analytical testing of inhalation and oral dosage forms; proficiency with advanced analytical techniques and regulatory standards; experience with risk assessments and impurity control; meticulous laboratory practices; strong collaboration skills. Preferred: experience with inhalation products and combination formulations. HighValue: GMP compliance, analytical validation, inhalation and oral dosage forms, CMC support, regulatory documentation, phase development support. WorkSetup: full-time, on-site in Bridgewater, NJ; minimal travel.