Aseptic CAR-T Manufacturing Operator

Overview

About Innovative Medicine:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at

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

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.

• 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.
• Handle Patient Blood, Viruses and Patient Cells in various containment bags/containers. Wear PPE (Proper Protective Equipment) and be trained in the site s Biohazard Control Plans and additional clean room trainings.
• Read and understand all standard operating procedures and work in electronic systems. Undergo a full qualification process through the internal training department to qualify to perform the operator s duties. Qualification and maintaining Qualification status are required for the role.
• If Applicable to the role, Aseptic Qualification must be maintained to avoid disqualification. Maintaining Qualification is required.
• Execute manufacturing activities common to cell culturing, purification, aseptic processing, cryopreservation, welding, sealing and using appropriate aseptic techniques.
• Record production data in a clear, concise format according to Good Documentation Practices (GDP) and ALCOA+.
• Work in a team-based environment (2+ Operator Process) on a specific patient batch with collaboration to execute the process.
• Support in Workshops or general process improvement programs to 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 alignment with quality systems and cGMP requirements.
• Maintain flexibility with a dynamic day-to-day schedule of tasks within a standard shift schedule.
• Accurately complete documentation in SOPs, logbooks, and other GMP documents.
• Demonstrate training progression through the assigned curriculum.
• Maintain working knowledge of basic cGMP requirements to ensure adherence to compliance policies and regulations.
• Wear appropriate PPE in manufacturing and other hazardous environments (Grade D, C, B,
  
  A). Gowning may include a full Tyvek suit, clean room scrubs, hairnet, mask, face shield, and multiple gloves for Grade C/D spaces.
• Proactively maintain a clean and safe work environment and communicate unsafe behaviors.
• Operator role requires standing for long periods and staying in the clean room to operate on a patient batch for several hours.
• Punch in/out on a physical time clock daily and submit PTO per the Raritan Attendance Policy.

• Support the ongoing production schedule by reporting to work on time according to the shift schedule (e.g., bi-weekly rotating schedules).
• Attend departmental and other scheduled meetings (Shift Start Meeting, Tier Meetings, Investigations, etc.).
• Practice good interpersonal and communication skills; demonstrate a positive team-oriented approach.
• Promote teamwork; learn new skills and procedures as assigned; continue professional development.
• Support investigations as required and participate in audits.
• * This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.

• COMPUTER ABILITY: Advanced understanding and working knowledge of systems required per curriculum. Utilizes MS Office and other systems to improve…