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Insmed

Develops therapies for rare diseases

Upstream Pilot Plant Manager

Bioprocess & BiomanufacturingUpdated on Nov 13
Full-timeSan Diego, CA, USA

About the Job

Requirements

  • A bachelor's degree in Biology, Chemical Engineering, or Biochemistry and five years of experience in upstream process development or manufacturing support in bioprocessing.
  • Hands-on experience with mammalian or microbial cell culture, seed train expansion, bench-, pilot-, or production-scale bioreactor operations, and media/buffer preparation.
  • Knowledge and application of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
  • 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.
  • Strong technical writing and communication skills.
  • Ability to maintain a safe working environment and remain current with assigned training.

Responsibilities

  • Execute upstream processes, including cell culture expansion, bioreactor operations at bench, pilot, and production scales, and media/buffer preparation.
  • Operate and maintain upstream bioprocessing equipment, including 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, standard operating procedures (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.
  • Use 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.
  • Maintain a safe working environment and stay current with assigned training.

Desired Qualifications

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

About the Company

Insmed

Develops therapies for rare diseases

Insmed focuses on developing and delivering therapies for serious and rare diseases. Its products come from a pipeline of clinical trials and approved treatments, sold to patients in global markets with offices in Bridgewater, NJ, Europe, and Japan. The company’s work combines research and development, regulatory approvals, and commercialization to bring therapies from discovery to patients. Insmed differentiates itself by addressing unmet medical needs in rare diseases and maintaining a global infrastructure that supports development, approval, and patient access. The goal is to improve patient outcomes by providing effective treatments for conditions with limited existing options.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Bridgewater Township, New Jersey
Founded
1988

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