CAR-T Manufacturing Operator

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We are searching for the best talent for CAR-T Manufacturing Operator to be in Raritan, NJ.

Purpose: This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment. This position is responsible for the quality and maintaining the highest standards in compliance with company policies, procedures, and all applicable regulations. Responsible for fostering site pride and J&J citizenship.

You will be responsible for:

• 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.
• 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.
• 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.
• 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.
• Execute manufacturing activities common to cell culturing, purification, aseptic processing, and cryopreservation, welding, sealing and using appropriate aseptic techniques.
• Responsible to record production data and information in a clear, concise, format according to Good Documentation Practices (GDP) and following ALCOA+.
• Work in a team-based (2+ Operator Process) on a specific patient batch. Collaboration in the process to execute is required.
• Support in Workshops or general process improvement programs to help aid in the development of manufacturing processes/SOPs.
• Handle human-derived materials in containment areas such as LFGIs, Containment Hoods & Biosafety Cabinets.
• Perform tasks on time in a manner consistent with quality systems and cGMP requirements.
• Flexibility with a dynamic Day to Day schedule of tasks within a standard set shift schedule.
• Accurately complete documentation in SOP’s, logbooks, and other GMP documents.
• Demonstrate training progression through the assigned curriculum.
• Accountable for maintaining a working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations.
• Wear the appropriate PPE when working in manufacturing and other hazardous working environments (Grade D, C, B,
  
  A). Examples of Gowning will be a full Tyvek suit which fully encloses operator when working in a Grade A/B Space. Clean Room Scrubs, hairnet, face mask, face shield, multiple gloves for Grade C/D.
• Proactively maintain a clean and safe work environment. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors.
• Operator Role requires standing for long periods of time and ability to remain in the clean room to operate on a patient batch for several hours at a time.
• Required to Punch in and out on a physical time clock daily without missing their schedule punches. All PTO to be submitted in a timely manner as outlined in our Raritan Attendance Policy.

Additional Responsibilities / Duties:

• Support the ongoing production schedule by:
• Report to work on time and according to the shift schedule (Bi-weekly rotating schedule such as Sunday-Wed/Sunday-Tuesday or Wed-Sat/Thursday-Sat)
• Attend…