Manager, Contract Manufacturing

Insmed Incorporated•NJ Corporate Headquarters, NJ

1d•$124,000 - $161,000•Remote

About The Position

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.

Requirements

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.

Nice To Haves

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

Responsibilities

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
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.
Contribute to the transition of spray drying and other drug product processes from pilot and commercial scale at primary and secondary CMOs.
Troubleshoot spray drying and other drug product process equipment, ensuring efficiency and compliance with GMP regulations.
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.
Work closely with formulation scientists, manufacturing teams, and regulatory affairs to ensure smooth product development and commercialization.
Ensure all processes comply with FDA, EMA, and ICH guidelines for pharmaceutical manufacturing.
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
Access to our Employee Assistance Program (EAP)
Generous paid time off policies
Fertility and family-forming benefits
Caregiver support
Flexible work schedules with purposeful in-person collaboration
401(k) plan with a competitive company match
Annual equity awards
Participation in our Employee Stock Purchase Plan (ESPP)
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
Meaningful opportunities to connect, volunteer, and give back