CAR T MOI QCCB 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 https://www.jnj.com

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 CAR T MOI QCCB Operator to be in Raritan, NJ.

Purpose: This position is responsible for performing manufacturing procedures and executing scheduled tasks within a CGMP environment. This position is responsible for 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 MOI/QCCB, clinical and commercial preparation of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.

•        Independently execute MOI/QCCB or manufacturing-support processes according to standard operating procedures and current curriculum. 

•        Execute daily manufacturing activities for cell culturing, purification, aseptic processing, and cryopreservation using appropriate techniques.

•        Perform process unit operations according to standard operating procedures and batch records, and record production data and information in a clear, concise format according to Good Documentation Practices (GDP).

•        Perform tasks on time consistent with quality systems and cGMP requirements.

•        Work in a team-based, cross-functional environment to complete production tasks required by shift schedule.

•        Aid in the development of manufacturing processes, including appropriate documentation.

•        Drive continuous improvement of manufacturing operations leveraging own observation and input of team members.

•        Handle human-derived materials in containment areas.

•        Support schedule adjustments to meet production.

•        Accurately complete documentation in SOPs, 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 environments.

•        Proactively maintain a clean and safe work environment. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors

•        Ensure materials are available for production. 

ADDITIONAL RESPONSIBILITIES/DUTIES:

•        Support the ongoing production schedule by:

•        Report to work on time and according to the shift schedule.

•        Perform other duties as assigned.

•        Attend departmental and other scheduled meetings.

•        Practice good interpersonal and communication skills.

•        Demonstrate a positive team-oriented approach in the daily execution of procedures.

•        Promote and work within