Aseptic Operator

Overview:

• 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.

Experience:

• 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.

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