CAR T - MOI/QCCB TESTING OPERATOR

Company: Disability Solutions
Location: Raritan
Posted on: March 17, 2023

Job Description:

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a MOI/QCCB Testing Operator, CAR-T to be located in Raritan, NJ. At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. POSITION SUMMARY: This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations. Responsible for fostering site pride and J&J citizenship. AS THE MOI/QCCB TESTING OPERATOR, CAR-T, YOU WILL: ESSENTIAL FUNCTIONS:

• Be part of the manufacturing operations team responsible for MOI/QCCB, clinical and commercial preparation autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
• Independently execute MOI/QCCB Testing or manufacturing-support processes according to standard operating procedures and current curriculum.
• Execute manufacturing activities common to 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 in a manner 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 as well as input of team members.
• Handle human derived materials in containment areas.
• Support schedule adjustments to meet production.
• Accurately complete documentation in SOP's, logbooks and other GMP documents.
• Demonstrate training progression through 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.
• 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 positive team-oriented approach in the daily execution of procedures.
    • Promote and work within a team environment
    • Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
      • Support investigation efforts as required.
      • Responsible for audit preparation and participation. A UTONOMY and COMPLEXITY :
        • Needs direction to perform manufacturing daily tasks within functional area.
        • Support and contributes to projects
        • Assist in troubleshooting routine manufacturing processes
        • Support and execute non-routine manufacturing activities. Are you interested in joining a team that is positively impacting patient's lives through cutting edge cell therapy? Apply today to be part of the #CAR-T team!

Keywords: Disability Solutions, Trenton , CAR T - MOI/QCCB TESTING OPERATOR, Other , Raritan, New Jersey