CAR-T Manufacturing Operator

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Assembly

Job Category:

Business Enablement/Support

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

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 https://www.jnj.com/innovative-medicine 

We are searching for the best talent for a 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. 

Duties / Responsibilities

• 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. 
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