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Aseptic Manufacturing Operator

Aseptic Manufacturing Operator

Mantell AssociatesNJ, United States
3 days ago
Job type
  • Full-time
Job description

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 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

    • 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.