Associate Director of Operations

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.

 

Legend Biotech is seeking an Associate Director of Operations as part of the Technical Operations team based in Raritan, NJ. 

Role Overview

The Associate Director of Operations is an exempt level position working within Technical Operations. This individual will be responsible for overseeing the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment.

Key Responsibilities  

• Oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements.
• Oversee the hiring, development, and performance management of staff, and assign personnel to execute daily production schedules.
• Be responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics.
• Support manufacturing investigations, support, and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections.
• Lead facility operating review meetings and own various department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations.
• Support the operations organization build, operations ramp-up of commercial and clinical production.
• Build strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production schedules.
• The role will require proven leadership to drive effective communication, coordination, and collaboration across relevant cross functional groups to ensure robust production, testing and release of product to patients.

Requirements

• B.Sc./M.Sc. in Biological/Biochemical Science/Bioengineering or related field.
• Minimally 8+ years of combined experience in cGMP manufacturing, operations management, tech transfer, process and equipment validation and quality management, with a preference for Cell/Gene Therapy experience
• Minimum of 5 years of experience in a leadership role in Biologics and/or cell therapy operations
• A history of developing and building cohesive, high performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and ensure strong succession planning
• Communicates effectively with people at all levels, including the ability to understand their priorities, and to earn their respect and trust, along with the willingness to provide them with the best decisions in time-sensitive situations
• Excellent teamwork and interpersonal skills with ability to influence and build strong working relationships at all levels
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• 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.
• Clear and succinct verbal and written communication skills.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Project management skills, responsiveness to issues, and demonstrated passion for creating new medicines.
• Experience with Operational Excellence and/or Lean Manufacturing is an asset.

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Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or ha