QC Technical Trainer

Legend Biotech is seeking a QC Technical Trainer as part of the Quality team based in Raritan, NJ.

Role Overview

The QC Technical Trainer is an exempt level position working within Training team, responsible for directing new hires to complete their daily system trainings performing QC related test methods and process qualification trainings to support the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment. This position is primarily a M-F schedule, with potential nights or weekends temporary coverage.

Key Responsibilities

• This individual will lead and supervise onboarded CAR-T new hires through their initial training process up to their process qualifications. Specifically, this individual will ensure new hires complete their system required trainings, equipment, and process trainings.
• Be responsible to conduct training for QC test methods and any other QC process qualifications to QC analyst.
• This individual will work closely with QC Leads/supervisors to ensure planned training events were completed as scheduled.
• This individual's primary responsibility will be to work closely with the Training Team and help coordinate the new hires with the completion of their trainings / qualifications, in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Support in daily completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
• Ensure testing and training is completed in compliance with all applicable procedures, standards and GMP regulations.
• Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
• Perform peer review/approval of laboratory data. This individual will work closely with the QC Management to help oversee the development of new hires into the QC environment and ultimately into their assigned QC Teams. The individual will need to provide immediate input on new hire performance and help correct any learning discrepancies.
• This individual will need to build strong partnerships with Training, SMEs, and Quality Assurance to ensure seamless execution of daily training and qualification tasks and work as part of a cross-functional team to address training issues as the first point of contact for new hire's integration on to the QC Labs.
• This individual will support the development of training / qualification processes, participate in various department projects, and will work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations.

Requirements

• A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
• A minimum of 5 years work experience within a biological and/or pharmaceutical industry is required.
• A minimum of 2 years experience of relevant work experience.
• Experience in a Quality Control setting is preferred.
• Experience with biosafety cabinets is required.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
• Knowledge of Good Tissue Practices is required.
• Detailed knowledge of CAR-T QC test methods and related equipment is preferred
• Excellent written and oral communication skill are required
• Candidates must be able to accommodate occasional weekend and evening work as required by the manufacturing process.
• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
• The 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 partner sites in NJ or PA as business demands.

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