QC Technical Trainer III

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. Legend Biotech is a global biotechnology company dedicated to treating 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 R&D sites around the world, we these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

The QC Technical Trainer is an exempt level position working within the QC Microbiology training team. This individual will perform training activities for Quality Control Microbiology team members who support cGMP Clinical and Commercial Cell Therapy testing. The role requires technical experience, effective communication, coordination, and collaboration across relevant cross‑functional groups to enable robust testing and release of products to patients.

This position is primarily a M‑F schedule, with potential nights or weekends temporary coverage as needed.

• Lead, coach, and deliver trainings for the Quality Control Microbiology team and Operations team.
• Conduct training and qualify QC Microbiology Specialists on QC test methods.
• Collaborate with QC Onboarding Associate(s)/QC Leads/Supervisors to ensure planned training events are completed on schedule and provide feedback as needed.
• Perform Observation, Side‑by‑Side, and Instructor‑Led Training inside the laboratory and CAR‑T cGMP Manufacturing facility.
• Conduct knowledge and skill checks and independent performance qualifications for Quality Control Microbiology inside the laboratory and CAR‑T cGMP Manufacturing facility.
• Ensure testing and training are completed in compliance with all applicable procedures, standards and GMP regulations.
• Support day‑to‑day Quality Control Microbiology activities as needed.
• Perform peer review/approval of laboratory data as needed.
• Write or revise SOPs, Work Instructions, Job Aids, knowledge, and skills assessments.
• Optimize the effectiveness and efficiency of the training program in delivering qualified personnel.
• Work cross‑functionally with the training team to ensure development/qualification processes.
• Support investigations and evaluate improvement opportunities for effective compliant training performance leading to sustained right‑first‑time execution.
• Provide awareness trainings to the Quality Control Microbiology team.
• Perform trainings within CAR‑T manufacturing facility inside cleanroom environments.
• Serve as subject matter expert for Learning Management Systems.
• Support the maintenance and reporting of quality training metrics.
• Perform other duties as necessary.

• A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline.
• 0‑2 years relevant work experience, preferably within a biological and/or pharmaceutical industry.
• Experience in a Quality Control setting is preferred.
• Experience with biosafety cabinets is required.
• Candidate must have experience working within an aseptic manufacturing facility, preferably within quality control, quality assurance, training/systems applications, quality systems, or learning management systems.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell‑based products.
• Knowledge of Good Tissue Practices.
• Experience with training methodology, adult learning theory, and train‑the‑trainer programs.
• Curriculum and module design experience.
• Detailed knowledge of CAR‑T QC test methods and related equipment.
• Excellent written and oral communication skills.
• Candidates must accommodate occasional weekend and evening work as required by the manufacturing process.
• Candidates must accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
• Candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Comfortable with speaking and interacting with inspectors.
• This position may require occasional travel to…