Manager, Quality Control

Role: Manager, Quality Control (QC) at Insmed, overseeing external laboratory testing for inhalation and small molecule drug substances and products, ensuring compliance with cGMP and regulatory standards. Responsibilities: independently manage QC activities, lead analytical projects, review data, investigate deviations and OOS/OOT issues, support method implementation, review and approve CoAs and protocols, contribute to regulatory submissions, and monitor lab performance. Requirements: Bachelor's in Chemistry, Biochemistry, or related field with 4+ years QC experience in biotech/pharma, expertise in analytical testing of small molecules or inhalation products. Preferred: MS degree, familiarity with combination products, strong knowledge of cGMP, ICH, USP/EP/JP standards, and experience managing contract labs. High-Value: inhalation dosage forms, analytical method troubleshooting, regulatory submission support, GxP environment. Work setup: onsite in Bridgewater, NJ, with ~10% domestic travel.