Manager, Contract Manufacturing

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for a Manager, Contract Manufacturing on the Logistics team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Contract Manufacturing, you’ll oversee outsourced production at Contract Manufacturing Organizations (CMOs) or third-party manufacturers (TPMs), ensuring on-time delivery, high quality, and cost-effective production of pharmaceutical drug substance, drug product, and primary packaging. Key responsibilities include managing CMO performance, driving quality compliance (GMP), and overseeing routine execution of manufacturing operations for pharmaceutical products. What You'll Do: In this role, you’ll have the opportunity to oversee the routine execution of manufacturing operations, resolution of technical issues, as well as deviations and change controls for pharmaceutical products. You will collaborate with cross-functional teams, including, MS&T, Quality Assurance, Regulatory CMC, and CMOs to ensure robust and compliant production processes. You’ll also: CMO Oversight: Oversight of routine manufacturing and resolution of technical issues as well as supporting change controls and deviations Documentation: Responsibility for commercial manufacturing related program documentation/tracking, i.e. MBRs, change controls, deviations, progress reports, PO and budget tracking, CMC supporting documentation, etc. Cross-Functional Collaboration: Work closely with Supply Chain, Quality Assurance, Quality Control, Regulatory CMC, Finance, Procurement, Project Planning and CMO’s to ensure uninterrupted supply of Pharmaceutical Product Regulatory Compliance: Ensure all processes comply with FDA, EMA, and ICH guidelines for pharmaceutical manufacturing Quality and Compliance: Collaborate with QA to ensure compliance with GMP, regulatory requirements, 21 CFR 212, and manage deviations/CAPA Supply Chain Coordination: Coordinate with internal supply chain teams for forecasting, material procurement, and inventory management Travel: Travel to vendor and manufacturing locations for support of manufacturing activities Who You Are: You have a Bachelor’s degree along with 5 years of experience in pharmaceutical manufacturing, supply chain, or pharmaceutical development. You are or you also have: Experience with commercial CMO operations Strong background in Manufacturing of Oral Solid Dosage forms including spray drying, tableting, and encapsulation technology for pharmaceutical applications Working knowledge of quality systems, validation principles, engineering design, and statistical process control fundamentals Proven ability to identify, assess, and solve technical problems Experience with GMP manufacturing, technology transfer, process scale-up, and validation High energy, innovative “can do” attitude Ability to work independently without the need for constant supervision Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment Strong verbal and written communication skills Nice to have (but not required): Advanced degree in Pharmacy, Chemistry, Engineering Experience with inhaled powders, sterile manufacturing and blister primary packaging Experience with Minitab Where You’ll Work This is a hybrid role based out of our Bridgewater, NJ office. You’ll have the o ... (truncated, view full listing at source)