Manager, Upstream Pilot Plant
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: We’re looking for a Manager, Upstream Pilot Plant on the Manufacturing team to help us expand what’s possible for patients with serious diseases. Reporting to the Associate Director, Manufacturing, you’ll play an essential role in the successful production of high-quality Gene Therapy products. Your responsibilities will span a variety of activities, including upstream process execution (cell culture and bioreactor operations), maintaining GLP-compliant documentation, operating and maintaining cell culture equipment, authoring records and procedures, and contributing to continuous improvement initiatives within viral vector manufacturing.
Requirements
- Bachelor’s degree in Biology, Chemical Engineering or Biochemistry
- 5 years of experience in upstream process development or manufacturing support in bioprocessing.
- Hands-on experience with mammalian or microbial cell culture, seed train expansion, bioreactor operations (bench, pilot, or production scale), and media/buffer preparation.
- Knowledge and application of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Proven ability to collaborate effectively within cross-functional teams in a manufacturing or development environment.
- Experience supporting manufacturing investigations, root cause analysis, and deviation resolution in biologics production.
- Familiarity with Quality Systems, Enterprise Resource Planning (ERP) platforms, and electronic documentation systems.
Nice To Haves
- Experience conducting manufacturing investigations in biologics or cell culture based production.
Responsibilities
- Execute upstream processes, including cell culture expansion, bioreactor operations (bench, pilot, and production scales), and media/buffer preparation.
- Operate and maintain upstream bioprocessing equipment such as wave/rocking platforms, stirred-tank bioreactors, incubators, and automated control systems.
- Prepare, sterilize, and manage cell culture consumables while ensuring aseptic technique in all operations.
- Maintain strict adherence to current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Prepare, review, and maintain batch records, SOPs, logbooks, raw material specifications, technology transfer documents, and campaign summary reports.
- Ensure compliance with company SOPs, training requirements, and best practices for scale-up and technology transfer.
- Maintain facility readiness and support inspections through vigilant oversight of upstream operations.
- Utilize Quality Systems and Enterprise Resource Planning (ERP) tools to record and track production activities.
- Provide upstream process subject matter expertise and take ownership of assigned deliverables.
- Demonstrate strong technical writing and communication skills.
- Always maintain a safe working environment and remain current with assigned training.
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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
