About the Role:
Manager, External 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.
• Abilty to be onsite at CMO in Greenville, NC (at least 25%) and some international travel.

Where You'll Work

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

Travel Requirements

This position involves frequent domestic & some international travel up to 25%.

#REMOTE

#LI-BA1

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 grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• 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

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Current Insmed Employees: Please apply via the Jobs Hub in Workday.