Operations Associate, 2nd Shift

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking an Operations Associate 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.

Shift

Schedule:

Wed-Sat 2nd Shift

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.
• Support the ongoing production schedule by reporting to work on-time and according to the shift schedule, performing other duties as assigned, attending departmental and other scheduled meetings, practicing good interpersonal and communication skills, demonstrating a positive team-oriented approach in the daily execution of procedures, promoting and working within a team environment, learning new skills, procedures, and processes as assigned by management, continuing to develop professionally, supporting investigation efforts as required, and being responsible for audit preparation and participation.

• HS Diploma required with 3 – 5 Years Biotech/Pharmaceutical experience or equivalent industry experience // OR // Associates Degree required in Life Sciences or Manufacturing with 2 - 3…