CAR-T Training Supervisor

at  Legend Biotech EU

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.

EDUCATION:

• Bachelor’s or Master’s degree in Science, Bio-Engineering, Pharmacy or related field or equivalent experience required.

EXPERIENCE:

• A minimum of 3 years of experience within a cGMP or ATMP environment in the biotech/biopharma industry.
• At least 3 years of aseptic GMP manufacturing experience (grade A/B or C).
• Educational background and/or training experience within a GMP or scientific industry environment.
• Experience with Learning Management Systems and working in a digital Quality Management System

CAPABILITIES, KNOWLEDGE, AND SKILLS:

• Knowledge of cGMP regulations and EMEA/FDA aseptic guidances related to manufacturing of cell-based products.
• Strong communication and organizational behaviors to effectively lead a team.
• Must exhibit strong leadership skills and ability to effectively communicate towards team members and management.
• Ability to work independently and to successfully prioritize and manage multiple tasks simultaneously and balance competing priorities effectively.
• Strong organizational skills. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Analytical, problem-solving, pragmatic and positive critical-thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Can-do attitude, right-first-time and hands-on approach.
• Tenacity to drive issues until resolved and deliver results.
• Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes.
• Self-motivated, enthusiastic personality, team player, with a desire to learn new skills and train juniors.
• Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
• An engaged leader who is easily accessible for their team members and can actively and flexibly support their team by giving training.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.

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

• Serve as subject matter expert for the training processes and training organization within the CAR-T organization, towards external stakeholders and during internal audits and inspections.
• Review and write procedures, work instructions, training documents, risk assessments, etc. in support of the training organization and the technical training programs.
• Maintain, monitor and report training metrics.
• Act as back-up for the Training Expert(s) for the following tasks: performing training impact assessments and determining the training approach for new and updated procedures, work instructions, master batch records and other documentation; supporting investigations, evaluating and implementing improvement opportunities for effective and compliant training programs leading to sustained right-first-time execution; reviewing change controls to assess impact on the technical training programs and defining and implementing the necessary change control actions.