Location: Raritan,NJ, USA
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 Operations Manager as part of the Technical Operations team based in Raritan, NJ.
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.
* Key Relationships:
Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within the organization.
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.
* Language: English
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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 harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech maintains a drug-free workplace.