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.

What You'll Do:

In this role, you'll have the opportunity to execute upstream processes, including cell culture expansion, bioreactor operations (bench, pilot, and production scales), and media/buffer preparation. You'll also:

• 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.

Who You Are:

You have a bachelor's degree in Biology, Chemical Engineering or Biochemistry along with 5 years of experience in in upstream process development or manufacturing support in bioprocessing.

You are or you also have:

• 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 have (but not required):

• Preferred: Experience conducting manufacturing investigations in biologics or cell culture based production.

Where You'll Work

This role is based out of our San Diego, CA office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs.

Travel Requirements

Minimal travel expected

#LI-BA

#LI-ONSITE

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.