Operations Manager

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop 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. Our three R&D sites worldwide apply these innovative technologies to pursue the discovery of safe, efficacious, and cutting‑edge therapeutics for patients worldwide.

Legend Biotech has entered into a global collaboration agreement with Janssen, a pharmaceutical company of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autoleucel (cilta‑cel). The partnership combines the strengths and expertise of both companies to advance an immunotherapy in the treatment of multiple myeloma.

The CAR‑T Operations 2nd Shift Manager is an exempt level position within Technical Operations. This individual will oversee the production of personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. The position is onsite, Monday to Friday, on the 2nd shift.

• Oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements.
• Serve as site management resource and point of contact for all 2nd shift employees.
• Act as the primary point of contact for 2nd shift Technical Operations supervisors within their respective areas of oversight.
• Take direction and guidance from the Associate Director and/or Senior Managers of the process areas.
• Hire, develop, and manage staff performance; assign personnel to execute daily production schedules.
• Create and revise operational procedures, including manufacturing work instructions, master batch records, and forms.
• Manage multiple work centers to ensure high quality and compliant product supply; oversee production metrics.
• Support manufacturing investigations, manage change controls, maintain inspection readiness, and actively support regulatory inspections.
• Build strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production schedules.
• Lead facility operating review meetings and own various department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations.
• Establish key relationships with internal and external stakeholders; interact with all levels within the organization.

• Bachelor’s degree in Engineering or related field, or equivalent experience.
• Minimum of 5 years of operations experience within a cGMP environment in the biotech/biopharma industry, with at least 3 years of supervisory experience;
  Cell/ Gene Therapy experience preferred.
• Ability to build strong partnerships and effectively collaborate in a matrixed environment.
• Ability to work independently, prioritize and manage multiple tasks simultaneously, and balance competing priorities.
• Capacity to manage shifting priorities, meet critical deadlines in a fast‑paced and dynamic environment, and provide clear direction to team members.
• Clear and succinct verbal and written communication skills.
• Strong analytical, problem‑solving, and critical‑thinking skills; ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Basic project management skills and responsiveness to issues; demonstrated passion for creating new medicines.
• Experience with Operational Excellence and/or Lean Manufacturing is an asset.
• Familiarity with modern manufacturing systems (MES, ERP, etc.) and digital transformation initiatives.
• Ability to accommodate shift work, including daily overtime, weekends, and unplanned overtime on short notice.
• GMP compliance and regulatory knowledge: deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.
• GMP compliance and regulatory knowledge is a requirement; familiarity with modern manufacturing system technologies is an asset.

Base pay range: $127,313 USD – $167,099…