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
- ?Bachelors 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 experienceExperi
- ence in aseptic cell culture processing in ISO 5 biosafety cabinets while using universal precautions for handling of human-derived materials highly preferredExperi
- ence in cell therapy automation technologies, closed system culture vessels, cell washers, cell separation technologies for autologous/allogenic product manipulation (preferred)Experi
- ence 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 documentationExcell
- ent communication skills, both verbal and writtenMante
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l Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.