Car-t Training Expert

il y a 1 mois

Gent, Belgique Legend Biotech EU Temps plein

**Company Information**

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 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) in 2017. 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.

**Position Overview**

The CAR-T Training Expert will support the Training & Capabilities organization as part of the ramp-up of production towards commercial launch and sustained production. The CAR-T Training Expert will work in close collaboration with the different Training & Capabilities teams and with other departments such as Manufacturing Operations, QC IPC Operations, Supply Chain and Warehouse, Quality, MS&T and Facilities & Engineering and with external stakeholders. The role requires GMP experience, aseptic and technical experience, educational and training skills, and effective communication skills to coordinate and collaborate with other departments

**Major Responsibilities**

Take the lead in training development, compliance and continuous improvement
- Set up, maintain and continuously improve the content and effectiveness of the technical trainings and training programs for operational departments (Operations Manufacturing, Warehouse, Quality Control) and supporting departments.
- Balance and optimize the effectiveness and efficiency of the technical training program by maintaining clear goals and success criteria for each training in the training programs, thereby ensuring new hires are fully trained within predefined lead times.
- Identify technical training needs and expectations, monitor progress, address and resolve gaps in training requirements as part of the technical training programs.
- Ensure alignment of the technical training content with the CAR-T manufacturing processes and procedures and work instructions.
- Closely follow up with the various training single points of contact (SPOCs) to ensure alignment of these trainings with the manufacturing processes and between all trainings and to ensure the same training approach.
- Manage the training curricula associated with the technical trainings and training programs.
- Ensure alignment between trainers by guiding new Training team members, sharing knowledge and re-training trainers, and by performing occasional quality checks.
- Perform training impact assessments and determine the training approach for new and updated procedures, work instructions, master batch records and other documentation.
- Support investigations and evaluate and implement improvement opportunities for effective and compliant training programs leading to sustained right-first-time execution.
- Review change controls to assess impact on the technical training programs and define, lead and implement the necessary change control actions.

Support the daily activities of the Training team and Training & Capabilities department
- Give training (classroom training, practical training, evaluations, onboarding) up to 30% of the time.
- Be a first point of contact for all content-related questions from the Training team colleagues.
- Be the training SPOC for a small number of complex technical trainings within scope of the training team, maintaining and continuously improving the content and effectiveness of those trainings and ensuring alignment with the manufacturing processes.
- Guide and coach new hires and juniors within the Training & Capabilities department.
- Lead internal Training team meetings and external stakeholder meetings where requested. Participate in other meetings with training impact and ensures effective reporting of the outcome to the Training Manager and/or Training & Capabilities teams where necessary.
- Identify (potential) issues and implement continuous improvement initiatives for the Training team.
- Assign training-related actions and projects to the Training team members in collaboration with the Training Supervisor and/or Training Manager, and closely monitor progress.
- Ensure availability and accessibility of all training lab workstations, materials and equipment needed for the technical training programs. Oversee the various lab management tasks (5S of the training labs, management of training equipment, materials, documentation and labels) and other SME roles within the team (investigations, document and training control).
- Ensure safe and compliant operations according to EHS and cGMP procedures and requirements.
- Escalate issues regarding training capacit

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