Aseptic Manufacturing Operator

Mantell Associates is partnered with a leading Cell Therapy CDMO in their search for an Aseptic Manufacturing Operator.

Aseptic Manufacturing Operator - Responsibilities:

• 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
• Work to complete documentation of deviations and events in appropriate systems
• Participate in cross-functional teams to complete projects
• Performs other duties as assigned

Aseptic Manufacturing Operator - Requirements:

• 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
• Experience in cell therapy automation technologies, closed system culture vessels, cell washers, cell separation technologies for autologous/allogenic product manipulation (preferred)
• Experience in handling, propagation, isolation, activation, and cryopreservation of human primary cells, including T cells (preferred)
• Strict adherence to SOPs, GMP regulations, FDA guidance, and ability to accurately complete associated documentation
• Excellent communication skills, both verbal and written

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.