Training Supervisor

Legend Biotech USA; Raritan (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Legend Biotech is seeking a Training Supervisor in Raritan, NJ to lead the training program for clinical and commercial CAR-T production. You will oversee a training team and collaborate with Operations and Quality to ensure cGMP compliance and safe, efficient manufacturing.

The role requires a Bachelor's degree in a technical field and at least 6 years of relevant experience within aseptic manufacturing or training systems. Strong communication and problem-solving skills are essential.

Qualifications

• Bachelor's degree in Science, Information Science or equivalent technical discipline is required.
• Minimum 6 years of relevant work experience in aseptic manufacturing or training/system applications.
• Knowledge of cGMP regulations and FDA/EU guidance for cell therapy manufacturing.
• Ability to manage shifting priorities and meet critical deadlines in a fast-paced environment.
• Strong analytical, problem-solving and communication skills to lead as a change agent.
• Advanced computer skills including MS Office, SharePoint and related systems.

Responsibilities

• Leads and develops a comprehensive training program for all plant personnel supporting clinical and commercial CAR-T production.
• Manages planning, coordination, and deployment of training curricula.
• Performs training assessments for new and updated procedures and skills checks.

Skills

Training leadership

Communication

Analytical skills

Change management

Problem solving

Project coordination

Education

Bachelor's degree in Science/Information Science or equivalent

Tools

MS Office Suite

SharePoint

Job description

Legend Biotech is seeking a Training Supervisor as part of the Operations team based in Raritan, NJ.

Role Overview

The position will be responsible for supervising the training team who lead training activities for the overall plant team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will oversee the Training team members in collaboration with department management in Operations and Quality to support personalized cell therapy production through safe and compliant operations according to cGMP requirements. This individual will support organization build and rampup of clinical production and facility approval of a state of-the-art cell therapy facility for commercial launch and sustained production. The role will require technical experience, effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.

Key Responsibilities

• Leads, directs, coaches and develops a holistic, effective training program for all plant functions and personnel that support daily clinical production and strategically prepares for commercial supply of a CAR-T product.
• Manages training team to plan, coordinate, prepare and deploy training curriculum.
• Perform training assessments for new and updated procedures.
• Oversee and schedule training skill checks and qualifications.
• Support evaluation of appropriate compliance courses.
• Leads and works with training team to manage training requirements for new hires.
• Work collaboratively with functional leads for procedure alignment based on roles.
• Serve as subject matter expert for Compliance & Training systems.
• Make recommendation for future system upgrades.
• Troubleshoot problems reported by system users.
• Knowledge of LMS system.
• Maintain and report quality training metrics.
• Prepares information for internal and external audits.

Requirements

• A minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required.
• A minimum of 6 years relevant work experience is required. It is preferable that the candidate have experience working within an aseptic manufacturing facility, preferably in training/system applications, quality systems, or learning management systems.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
• Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Advanced computer skills and practical knowledge of MS Office Suite, SharePoint, and other related systems.
• Good verbal and written communication skills.
• Excellent organizational skills.
• Ability to effectively prioritize and execute tasks in a fast-paced environment.
• Works well in a team-oriented, collaborative environment.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
• Proactive and continuous improvement oriented.
• Ability to lead with influence.
• cGMP manufacturing.
• Able to manage shifting priorities to meet critical deadlines in fast paced and dynamic, growing environment, while providing clear direction to team members.
• Strong analytical, problem solving and critical thinking skills.
• Project management.
• Change management

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

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