Manufacturing Manager Jobs

Our client, a cutting-edge cell and gene therapy company based in Cambridge, MA, is seeking a talented GMP Manufacturing Manager.

Responsibilities:

• Prepare protocols for aseptic process qualification studies and process engineering runs.
• Prepare equipment specifications for cGMP manufacturing, procure equipment, and support equipment validation studies.
• Develop in-process testing plans.
• Work with the manufacturing team to execute qualification/validation studies and prepare documentation and reports.
• Write SOPs for equipment operation, maintenance, and calibration.
• Produce Cell Drug Substance and Product for studies and trials.
• Assist in the development of appropriate analytical methods as needed.
• Perform technology transfer of manufacturing processes

Qualifications:

• Experience with Good Documentation Practices is required.
• Hands-on experience in cell therapy/cell culture production and aseptic manufacturing techniques is required.
• Bachelor's degree in a scientific field.
• 2+ Supervisory experience is required

If you are passionate about advancing cell and gene therapy and have experience in cGMP manufacturing, we encourage you to apply for this exciting opportunity with our client.