Associate Director, Operations Training and Investigations

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 an Associate Director, Operations Training and Investigations as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The Associate Director, Operations Training and Investigations, will provide strategic direction and leadership for the investigations management system as well as the Operations training door to floor program. This individual will oversee the Training and Investigations 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. 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.
• Serve as subject matter expert for Compliance & Training systems.
• Maintain and report quality training metrics.
• Prepares information for internal and external audits.
• Address recurring deviations and improve investigation quality.
• Ensure productivity, timeliness, and quality of investigations and CAPA implementation.
• SPOC and integrator for allocating resources, including personnel, budget, and technology, to support the investigations management system.
• Collaborate with stakeholders across departments to address challenges related to deviation management, investigation quality, and batch disposition timeliness.
• Provide training and mentorship to enhance the skills and capabilities of investigation team members in deviation management.
• Monitor KPIs related to investigation quality, timeliness, closure rates, overdue records, and deviations recurrence, and take proactive measures to address gaps and improve overall performance.

Requirements

• Bachelor's degree in a scientific or related field; advanced degree preferred.
• Minimum of 10 years of experience, including minimum of 3 years in deviation investigations management and 5 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.
• Strong understanding of GMP regulations, root cause analysis methodologies, and CAPA processes.
• Proven leadership and team management skills.
• Excellent communication, collaboration, and stakeholder engagement abilities.
• Demonstrated track record of driving continuous improvement initiatives.
• Training and mentoring experience preferred.
• Must be willing to work onsite. Occasional flexibility based on business needs.

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

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.