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 a Facility Supervisor as part of the Maintenance & Metrology team based in Raritan, NJ.
Role Overview
The CAR-T Facility Supervisor is an exempt level position working within Technical Operations team. This individual will be responsible for managing facility maintenance activities, including corrective and preventative maintenance and safely ensuring reliable and compliant facility operations according to cGMP requirements. This individual will provide oversight for a team of maintenance specialists and partner with cross functional areas in support cell therapy production for clinical and commercial patients.
Key Responsibilities
- Supervises an effective maintenance team that supports daily production of a CAR-T manufacturing facility.
- Maintains safety standards and training in the department; ensures that the building is maintained in a clean and safe manner which includes performing monthly operational/safety inspections.
- Supervises maintenance personnel to ensure all corrective and preventive maintenance are completed in a timely manner and documented in accordance with all cGMP, company policies, and appropriate regulatory standards.
- Performs work review, approval and close out of work orders, including management of third-party vendor work, in accordance with established guidelines and operating procedures.
- Enforce all departmental and organizational policies and procedures.
- Ensures proper materials, parts and spare parts are identified and available.
- Supports team compliance to Lock Out/Tag Out programs, Hot Work permits, confined space entry programs, facility emergency response plans and other required safety programs. Supports Quality driven initiatives related to facilities work such as change control, deviation, and corrective actions.
- Ensure collaboration with key stakeholders and functions.
- Supports the planning, coordination, preparation, and timely execution of maintenance shutdowns.
- Supports the development of PMs, job plans and/or master data.
- Inspect and evaluate the physical appearance of the facility and coordinate with site management for repairs.
- Report and address any unsafe conditions or environmental concerns.
Key Relationships
- Ability to interact with all levels within the organization. Operations, Quality, HSE, Supply Chain, Warehouse, Training, QC, EM, Operations Technical Support, Facilities and Engineering, MS&T/Finance.
Requirements
- High school diploma or GED required.
- Associate’s degree from a two-year college or technical school preferred.
- An ability to build strong partnerships with internal customers and effectively integrate with external vendors to drive facility operations.
- Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
- Ability to think critically, and demonstrated troubleshooting and problem-solving skills.
- Manage and work with vendors for routine equipment requirements and breakdowns.
- cGMP manufacturing.
- Maintenance and facilities management.
- Computerized maintenance management systems (CMMS).
- Quality Management knowledge, including Change control, Deviation, and CAPA’s.
- EHS and regulatory standards (e.g. EPA, OSHA and DEA) Candidate to have experience with operating and maintaining building security equipment.
#LI-BZ
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.
