Car-t Training Supervisor

il y a 2 semaines

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 Supervisor is responsible for leading and supervising the Training team and their daily activities supporting a personalized cell therapy for both clinical and commercial aseptic manufacturing according to cGMP requirements. The CAR-T Training Supervisor will lead and supervise the (Senior) Training Specialists and Technical Trainers and will support the Training & Capabilities organization as part of the ramp-up of production towards commercial launch and sustained production. The CAR-T Training Supervisor 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, Facilities & Engineering and Human Resources 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**

Manage people and the Training team organization
- Be the people leader for the (Senior) Training Specialists and Technical Trainers in the Training team.
- Lead the Training team on a daily basis, ensuring timely execution and effectiveness of the technical training program for operational departments (Manufacturing Operations, QC IPC Operations, Warehouse) and supporting technical departments (Quality, MS&T, Facilities & Engineering).
- Ensure effective onboarding of new hires within the Training team and guides and coaches new hires within the Training & Capabilities department.
- Coach the (Senior) Training Specialists and Technical Trainers and support their personal development in close collaboration with the Training Manager.
- Perform personnel performance evaluations with the (Senior) Training Specialists and Technical Trainers.
- Be the first point of contact for all organizational and human resources-related questions from the (Senior) Training Specialists and Technical Trainers.
- Manage correct assignment of training curricula for the (Senior) Training Specialists and Technical Trainers.
- Follow up on Training team capacity, availabilities and capabilities to ensure timely trainer readiness in support of the production ramp-up
- 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 actions and projects to the Training team members and closely monitor progress.
- Ensure safe and compliant operations according to EHS and cGMP procedures and requirements.
- Escalate issues regarding Training team resources and capacity, training content and training effectiveness in a timely manner to the Training Manager.

Ensure timely execution of the technical training programs
- Give training (classroom training, practical training, evaluations, onboarding) up to 30% of the time.
- 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).
- Oversee and review the monthly training schedule for all trainers and support the Training Coordinators with daily planning activities of the training schedule.
- Ensure alignment between trainers by guiding new Training team members, sharing knowledge and re-training trainers, and by performing occasional quality checks.
- Identify technical training needs and expectations, monitors progress, addresses and resolves gaps in training requirements as part of the technical training programs.

Be the SME for Training aspects within the organization
- Review and write procedures, work instructions, training documents, risk assessments, etc. in support of th

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