Car-t Manufacturing Operator

Johnson & Johnson Johnson & Johnson · Pharma · Raritan, NJ +1

Johnson & Johnson is seeking a CAR-T Manufacturing Operator in Raritan, NJ. This role involves performing manufacturing procedures and executing tasks within a CGMP environment, handling patient materials (blood, viruses, cells) in a cleanroom setting with appropriate PPE. Responsibilities include executing cell culturing, purification, aseptic processing, cryopreservation, welding, sealing, and accurate data recording according to GDP and ALCOA+ standards. The role requires working in a team, supporting process improvements, handling human-derived materials in containment areas, and maintaining a clean and safe work environment. Aseptic qualification and adherence to cGMP are critical. The role involves standing for long periods and working within a dynamic shift schedule.

What you'd actually do

  1. Be part of the manufacturing operations team responsible for the production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
  2. In this role you would be handling Patient Blood, Viruses and Patient Cells which is contained in various containment bags/containers. As part of handling patient material, you would wear PPE (Propper Protective Equipment) and be trained in the sites Biohazard Control Plans & additional clean room trainings.
  3. In order to be qualified to perform Operator functions you will need to be able to fully read and understand all standard operating procedures and work in electronic systems. There will be a full qualification process through our internal training department to qualify to perform the operator’s duties. Successful Qualification and maintaining Qualification status is required for the role.
  4. If Applicable to the role, Aseptic Qualification will be required to be maintained and to avoid any scenarios that would lead to disqualification. Maintaining Qualification is required for the role.
  5. Execute manufacturing activities common to cell culturing, purification, aseptic processing, and cryopreservation, welding, sealing and using appropriate aseptic techniques.

Skills

Required

  • Read and understand standard operating procedures
  • Work in electronic systems
  • Aseptic processing
  • Good Documentation Practices (GDP)
  • ALCOA+
  • Handle human-derived materials in containment areas
  • Adherence to compliance policies and regulations
  • Standing for long periods of time
  • Work within a team-based environment

Nice to have

  • Support in Workshops or general process improvement programs
  • Support the ongoing production schedule
  • Attending departmental and other scheduled meetings
  • Practicing good interpersonal and communication skills
  • Demonstrating a positive team-oriented approach
  • Promoting and working within a team environment
  • Learning new skills, procedures, and process
  • Supporting investigation efforts
  • Being responsible for audit preparation and participation

What the JD emphasized

  • cGMP environment
  • Aseptic Qualification will be required to be maintained
  • Maintaining Qualification is required for the role
  • Good Documentation Practices (GDP)
  • ALCOA+