INTRODUCTION

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 Operations Manager as part of the Technical Operations team based in Raritan, New Jersey.

ROLE OVERVIEW

The CAR-T Operations Manager 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

• This individual will oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements.
• This individual will also oversee the hiring, development, and performance management of staff, and assign personnel to execute daily production schedules.
• This individual will create/revise operational procedures, including manufacturing work instructions, master batch records, forms, etc.
• This individual will be responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics.
• This individual will support manufacturing investigations, support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections.
• This individual will need to build strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production schedules.
• This individual will also lead facility operating review meetings and own various department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations.
• Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within the organization.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses.
• Color Perception both eyes 5 slides out of 8.

REQUIREMENTS

• Bachelor's degree in engineering or related field or equivalent experience required.
• A minimum of 5 years of operations experience within a cGMP environment in the biotech/biopharma industry with a minimum of 3 years supervisory experience. Cell/Gene Therapy experience preferred.
• 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.
• Basic project management skills, responsiveness to issues, and demonstrated passion for creating new medicines.
• Experience with Operational Excellence and/or Lean Manufacturing is an asset.
• Ability to accommodate shift work including evenings and weekends as required by the manufacturing process.
• Ability to accommodate unplanned overtime on little to no prior notice.

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Li-Onsite

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.

For information related to our privacy notice, please review: Legend Biotech Privacy Notice.