Operations Associate

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma. Legend Biotech is seeking an Operations Associate (2nd Shift) as part of the Technical Operations team based in Raritan, NJ. Role Overview 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. Key Responsibilities Be part of the manufacturing operations team responsible for 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). 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. Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/40 (Snellen) or better with corrective lenses. Color Perception both eyes 5 slides out of 8. 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…