Goodwin Biotechnology

Scope of Function: Execute projects and tasks assigned by the manager in upstream clinical manufacturing activities including cell culture, cell banking, seed train preparation, bioreactor operations and harvest/clarification

Reports To: Manager, USP

Specific Duties:

  • Maintain laboratory inventory
  • Assist in writing standard operating procedures (SOPs), specifications, and manufacturing batch records (MBRs)
  • Participate in cell culture operations according to MBRs in compliance with cGMP regulations and guidelines
  • Participate in the thawing and freezing of cell banks
  • Maintain accurate and current documentation per GBI SOPs
  • Prepare medium and buffers to support USP projects
  • Maintain the GMP manufacturing areas per GBI SOPs
  • Assist with the execution of bioreactor operations including assembly, sterilization, setup, inoculation, daily checks, maintenance, harvesting, system shutdown and cleaning
  • Adhere to all GBI policies and safety guidelines
  • Perform all other duties as assigned

Education & Experience:

  • High School Diploma or equivalent with related biotechnology experience OR AS or BS in biological sciences, microbiology or physical sciences
  • 0-2 years working with cell culture or appropriate coursework
  • GMP manufacturing experience beneficial