[Hiring] Manager, Contract Manufacturing @Insmed Incorporated

Role Description

We’re looking for a Manager, Contract Manufacturing on the Manufacturing team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Manufacturing Sciences & Technology, you’ll be responsible for the development, optimization, scale-up, and routine execution of manufacturing operations for pharmaceutical products. A focus for this role is on-site presence at contract manufacturing organizations (CMOs) during production.

In this role, you’ll have the opportunity to collaborate with cross-functional teams, including R&D, manufacturing, quality assurance, regulatory CMC, and CMOs to ensure robust and compliant production processes. You’ll also be responsible for:

• CMO Oversight: Real-time and on-site supervision of CMOs execution of routine manufacturing as well as technology transfer, optimization, new equipment install, and process validation activities.
• Process Development & Optimization: Design, develop, and optimize manufacturing processes for pharmaceutical APIs and formulations; with an emphasis on particle engineering via spray drying and low fill weight powder encapsulation.
• Scale-Up & Tech Transfer: Contribute to the transition of spray drying and other drug product processes from pilot and commercial scale at primary and secondary CMOs.
• Troubleshooting & Operations: Troubleshoot spray drying and other drug product process equipment, ensuring efficiency and compliance with GMP regulations.
• Process Validation: Develop and execute validation protocols (IQ, OQ, PQ) for spray drying and other drug product processes. Prepare finalized spray dry and encapsulation 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.

Qualifications

• Bachelor’s degree along with 5 years of experience in pharmaceutical process engineering or manufacturing.
• Experience with late phase clinical and commercial CMO operations.
• Strong background in spray drying 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 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.
• Ability to work independently, remote from central leadership.
• Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment.
• Strong verbal and written communication skills are essential.

Requirements

• Background in capsule filling and blister primary packaging is a plus.

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.

Company Description

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.