Lead Operator, Cryopreservation

Janssen Pharmaceuticals, Inc. , a member of Johnson & Johnson's Family of Companies, is recruiting for a Lead Operator, Cryopreservation for CAR-T 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 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.

ESSENTIAL FUNCTIONS:

• 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.
• Independently execute manufacturing 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).
• 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 the 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 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.
• Perform tasks on time in a manner consistent with quality systems and cGMP requirements.

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 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.

*This is not an exhaustive or comprehensive listing of job functions.  May perform other duties as assigned.

AUTONOMY and COMPLEXITY:

• Independently perform manufacturing daily tasks on the production floor.
• Lead or assist troubleshooting of 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!