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 develop 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. From our three research and development sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, a pharmaceutical company of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). This partnership advances the promise of an immunotherapy in the treatment of multiple myeloma.

Location:

Raritan, New Jersey

Shift

Schedule:

Wed‑Sat 2nd Shift

This position is responsible for performing manufacturing procedures and executing scheduled tasks within a cGMP environment, ensuring the highest standards of quality and 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 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 the 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 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; take necessary action to eliminate safety hazards and communicate observed unsafe behaviors.
• Ensure materials are available for production.
• Job duties routinely require exposure to and handling of biological materials and hazardous chemicals.
• Maintain visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or 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 and continuing to develop professionally.
  • Supporting investigation efforts as required.
  • Being responsible for audit preparation and participation.

• High School Diploma with 3–5 years biotech/pharmaceutical experience, an Associate’s Degree in Life Sciences or Manufacturing with 2–3 years of related experience, or a Bachelor’s Degree in Life Sciences with 0–2 years of biotech/pharmaceutical experience.
• Inter…