Manager, Operations Training

Legend Biotech US • Raritan, NJ

6h • Hybrid

About The Position

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, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
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). 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.
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.

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.

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.

Benefits

• Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one.
• We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays.
• Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
• We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 501-1,000 employees