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Aseptic Operator

Posted: November 17, 2023
Salary:US$35 - US$40 per hour
Job type: Contract
Discipline:Life Sciences
Work Location:On-site

Job description


  • Develop and adopt new manufacturing procedures and analytical methodology.
  • Plan and perform complex components of process development for technology transfer.
  • Execution of manufacturing batch records with minimal instruction.
  • Support batch record reconciliation and timely documentation.
  • Successfully perform manufacturing activities in ISO7 clean room environment.
  • Execution of cell manufacturing and processing activities and maintaining aseptic technique during processing to ensure the highest integrity, viability, and sterility of cellular product until release.
  • Support production and characterization of genetically modified hematopoietic patient cells and genetically modified ancillary cells.
  • Perform data analysis and contributes to evaluation.
  • Participate in patient sample processing and maintenance of the corresponding database.
  • Assist in the development, writing, and updating of protocol documentation.
  • Reliably document all activities to meet cGMP requirements for review and revision. Organize and update daily record reviews, tasks, and databases. Actively provide feedback and effectively communicate with management.
  • Identify deviations, aid in investigations/root cause analysis, and provide input on major/critical deviations.


  • Minimum 3 years of relevant cGMP experience in the manufacturing of cell therapy or biologics.
  • Bachelor's degree in life sciences or engineering with at least 3 years of experience, or associate degree in life sciences with at least 5 years of experience.
  • Experience in aseptic cell culture processing in ISO 5 biosafety cabinets while using universal precautions for handling of human-derived materials highly preferred.
  • Strict adherence to SOPs, GMP regulations, FDA guidance, and ability to accurately complete associated documentation.
  • Excellent communication skills, both verbal and written.