MFG Operator Cryopreservation CAR T

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

Job Description:

Janssen Pharmaceuticals, Inc. , a member of Johnson & Johnson's Family of Companies, is recruiting for a MFG Operator Cryopreservation CAR T located in Raritan, NJ . #CART At Janssen, we never stop working toward a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, and you can count on us to keep working tirelessly to make that future a reality for patients everywhere, by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Arterial Hypertension. Visit us: POSITION SUMMARY: 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. *ESSENTIAL FUNCTIONS: --- Be part of the manufacturing operations team responsible for Cryopreservation, 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 Cryopreservation or manufacturing-support processes according to standard operating procedures and current curriculum. --- Execute manufacturing activities every day 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: o Report to work on-time and according to the shift schedule. o Perform other duties as assigned. o Attend departmental and other scheduled meetings. o Practice good interpersonal and communication skills. o Demonstrate positive team-oriented approach in the daily execution of procedures. o Promote and work within a team environment. o 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. AUTONOMY 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. NATURE OF TASKS: Manufacturing Operator --- Basic technical knowledge within functional units --- Demonstrate a basic understanding of the process to properly perform the assigned manufacturing tasks. Computer ABILITY: --- Basic understanding and working knowledge of systems required per curriculum. Utilizes tools within MS Office and other systems to improve business effectiveness. --- Accurate Data Entry skills in relevant manufacturing applications (SAP, electronic batch records (EBR), etc

Keywords: Disability Solutions, Plainfield , MFG Operator Cryopreservation CAR T, Other , Raritan, New Jersey