Manager, Operations Training

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

Role Overview

The Manager, Operations Training, will be responsible for managing the training team who lead training activities for the overall plant operation team members who support cGMP 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 the organization door to floor program and ramp-up of commercial 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 commercial production.
• 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.
• Oversees onboarding for all new manufacturing operators.
• Knowledge of LMS system.
• Maintain and report quality training metrics.
• Prepares information for internal and external audits.
• Ensure productivity, timeliness, and quality of Change Controls and CAPA implementation.

Requirements

• A minimum of a Bachelor’s Degree in Science; advanced degree preferred.
• A minimum of 5-8 years relevant work and management 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.
• Ability to effectively prioritize and execute tasks in a fast-paced environment.
• Works well in a team-oriented, collaborative environment.
• Demonstrated track record of driving continuous improvement initiatives.
• Proven leadership and team management skills.

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