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: Manager, Contract Manufacturing will be responsible for the development, optimization, scale-up, and routine execution of manufacturing operations for pharmaceutical products. A focus for this role is some on-site presence at contract manufacturing organizations (CMOs) during production in Greenville, NC). You will collaborate with cross-functional teams, including R&D, manufacturing, quality assurance, regulatory CMC, and CMOs to ensure robust and compliant production processes. What You'll Do: In this role, you will have the opportunity to provide CMO Oversight: Real-time and on-site supervision of CMOs execution of routine manufacturing as well as technology transfer, optimization, and validation activities. You will also: Process Development & Optimization: Design, develop, and optimize manufacturing processes for pharmaceutical APIs and formulations; with an emphasis on oral solid tableting. Scale-Up & Tech Transfer: Contribute to the transition of tablet manufacturing and other drug product processes from pilot and commercial scale at primary and secondary CMOs. Equipment & Operations: Troubleshoot of drug product process equipment, ensuring efficiency and compliance with GMP regulations. Process Validation: Develop and execute validation protocols (IQ, OQ, PQ) for oral solid tableting manufacturing and other drug product processes. Prepare finalized tablet processes for product registration, validation, and commercial readiness. Cross-Functional Collaboration: Work closely with formulation scientists, manufacturing teams, and regulatory affairs to ensure smooth product development and commercialization. Regulatory Compliance: Ensure all processes comply with FDA, EMA, and ICH guidelines for pharmaceutical manufacturing. Data Analysis & Reporting: Analyze process data, identify critical process parameters, and prepare technical reports for internal and regulatory submissions. Who You Are: You have a minimum of a Bachelor’s degree in Chemical Engineering or equivalent as well as 5+ years of experience in pharmaceutical process engineering, leading teams tasked with implementation of pharmaceutical manufacturing technology improvements within a regulated environment. You also have: Experience with late phase clinical and commercial CMO operations. Strong background in oral solid tablet manufacturing and primary packaging a plus. Working knowledge of quality systems, validation principles, engineering design, and statistical process control fundamentals. Proven ability to identify, assess, and solve problems using root cause analysis methodology and document investigation and outcomes in a compliant manner. Familiarity with DOE (Design of Experiments) and statistical process control. Experience with GMP manufacturing, technology transfer, process scale-up, and validation. High energy, innovative “can do” attitude is required. Ability to work independently, remote from central leadership. Onsite at CMO in Greenville, NC (at least 25%) and some international travel. Pay Range: $124,000.00-161,000.00 Annual Life at Insmed At Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you g ... (truncated, view full listing at source)