Manager, Contract Manufacturing

Insmed Incorporated

51d • Onsite

About The Position

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.

Requirements

• 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.
• Experience with late phase clinical and commercial CMO operations.
• 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.

Nice To Haves

• Strong background in oral solid tablet manufacturing and primary packaging a plus.

Responsibilities

• CMO Oversight: Real-time and on-site supervision of CMOs execution of routine manufacturing as well as technology transfer, optimization, and validation activities.
• 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.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

What This Job Offers

• Job Type: Full-time
• Career Level: Manager