Operations Associate

Overview

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 autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we pursue safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration with Janssen to jointly develop and commercialize cilta-cel, an immunotherapy for 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. It is responsible for quality and maintaining the highest standards in compliance with company policies, procedures, and all applicable regulations.

• 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 observations as well as 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 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 and communicate observed safety hazards.
• Ensure materials are available for production.
• Job duties involve exposure to and handling of biological materials and hazardous chemicals.
• Distance visual acuity requirements and color perception as described in job qualifications (no specific medical disclaimer beyond role requirements).
• Report to work on-time and according to the shift schedule.
• Perform other duties as assigned and attend departmental and scheduled meetings.
• Practice good interpersonal and communication skills; demonstrate a positive team-oriented approach and collaborate effectively.
• Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
• Support investigation efforts as required; participate in audits as needed.

• HS Diploma required with 3–5 years biotech/pharmaceutical experience or equivalent; or an Associate's Degree with 2–3 years related experience; or a Bachelor's Degree with 0–2 years related experience.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to follow instructions and solve practical problems with limited standardization.
• Proficiency in basic arithmetic and measurement units; knowledge and ability to operate manufacturing, manufacturing-support and lab equipment.
• Knowledge of Process Excellence Tools and routine/non-routine testing and sampling methods.
• Mobility to travel between sites as required by essential…