CAR T MOI QCCB Operator

Company: Disability Solutions
Location: Raritan
Posted on: September 21, 2024

Job Description:

Johnson & Johnson is currently seeking a CAR T MOI QCCB Operato r in Raritan, NJ.\rAt Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.\rFor more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.At Johnson & Johnson, we all belong.\rPOSITION SUMMARY:\rThis 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.\rESSENTIAL FUNCTIONS:

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• 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.\r\rADDITIONAL RESPONSIBILITIES/DUTIES:
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  • 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.
  • Available for overtime as needed.\r\r

Keywords: Disability Solutions, New Brunswick , CAR T MOI QCCB Operator, Other , Raritan, New Jersey