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, 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 Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.
ROLE OVERVIEW
The CAR-T Operations Support Lead is an exempt level position working with the Technical Operations team, responsible for the coordination and co-execution of the supporting activities to perform daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team-based environment, on an assigned production shift schedule.
RESPONSIBILITIES
The CAR-T Operations Support Lead is a supervisor on the floor and will lead, coordinate and co-execute the support of the CAR-T process operations (material transfer; replenishment and inventory; maintaining the clean rooms up to standards linked with the cleaning maintenance; packing, sealing and sterilization of materials and documents) according to standard operating procedures, and ensure safe and compliant manufacturing operations according to cGMP requirements.
The CAR-T Operations Support Lead will need to build strong partnerships within Manufacturing Operations (co Operations Support Leads, Technical Clean Room Leads, Supervisors and Manager), QC IPC Operations, Quality, Facilities & Engineering, MS&T/Manufacturing Excellence, Training, Planning, Warehouse to ensure seamless and timely execution of daily production tasks and work as part of a cross-functional team to address production support issues as the first point of contact for support operators on the production floor.
Be the SME for Quality aspects related to Production activities:
- Coordinate, manage and control all quality aspects related to support production activities:
- Review in a timely manner « documentation » activities in support Production zones (incl. Procedures, logbooks, transfer forms, S4 related documentation …)
- Act as a back-up for the Operations supervisor for the edition and review of logbooks, transfer forms (paper docs and MES)
- Conduct routine and non-routine (spot checks) inspection on documentation and GMP housekeeping in the support production zones
- Control in a timely manner production-related QMS documentation (in line with cGMP) in collaboration with MS&T and Quality:
- Deviations/events, and CAPA
- Support communication concerning KPI’s related to quality aspects in Production
- Production SME for internal audits and external audits in collaboration with QA (back-up of Operations Supervisor): 2nd point of contact representing Supporting Production quality matters in internal & external audits
- Responsible to escalate production-related matters to Operations Supervisor out of their empowerment zone to ensure timely decision and follow-up
Be the SME for Production support aspects related to CAR-T Products and Processes:
- Work closely and together with support operators to provide guidance and perform production tasks as needed to help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements
- Support optimisations of current processes within the support production areas
- Participate in various department projects, and will work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations.
- Communicate KPI’s related to supporting output in Production
- Provides support to writing and revising SOPs and associated documents (work files, checklists, procedures) related to routine Supporting Production documentation.
- Uses various manufacturing execution systems (e.g. eLiMS, SAP, MES), and supports to testing and implementation of these.
Production Organization and capabilities, people management:
- Works daily in a cleanroom manufacturing environment (Grade B/C/D & CNC)
- Controls and maintains the environment (equipment & facility cleaning and environmental monitoring) of the GMP production areas
- Manage packing, sealing and sterilisation of materials and documents
- Manage timely transfer of apheresis material, raw materials, consumables to the applicable clean room and manage timely final product transfer from production zone to CRF Zone
- Manage the waste in the applicable production zone and in concreto, frequency of emptying the waste airlock
- Manage inventory counts, preparation of internal orders, entry and exit from the zones, cleaning, replenishment and storage, according to SOPs and per issued planning
- Be present at the daily start of shift operations meetings and the daily wrap up production meetings. Act as a back up for the Ops Supervisor and lead the daily start of shift operations meetings, daily wrap up production meetings in his/her absence
- Assign to support operators their daily production task to execute and ensure compliance and successful completion of work-related tasks. Support organizing trainings together with Training/Operations Supervisor
- Work closely with Operations Supervisor & Ops Manager to help oversee the development of support operators and provide input on personnel performance
- Support to:
- Quality and EHS Risk assessment on supporting production activities
- the design, specifications, construction, qualification & validation of Supporting Production zones
- Identification of issues and continuous improvement initiatives for support production operations and areas
- Support to Alarm management of the support production zones, in collaboration with Maintenance/Engineering and Facility
- Act as a SPOC to the logistics warehouse for the material availability in the supporting production areas. Manage inventory in the WIP and storage of cleaning agents.
- Communicates clearly with the Ops Supervisor and Operations Technical Clean Room Lead to highlight on clean room status/material transfer status or any items related to safety, quality and efficiency
- Support to Monitoring the Production areas, incl QC Environmental control in collaboration with Maintenance/Engineering, QC and Facility
- Ensure safe and compliant manufacturing operations according to EHS and cGMP procedures and requirements
- Work in a constructive and flexible way in a team
Qualification
Education:
- Bachelor’s or Master’s degree in Science, Bio-Engineering, Pharmacy or related field or equivalent experience required.
Experience:
- Preferably 1,5 -3yrs years of operational experience within a GMP or ATMP environment in the biotech/(bio)pharma industry.
- At least 1 year experience in leading teams or Project management
Capabilities, Knowledge, and skills:
- Knowledge of cGMP regulations and EMEA guidance related to logistics or manufacturing and cleanroom behaviors.
- Must exhibit Leadership skills and ability to effectively communicate and influence support operators and convey information to Technical Clean Room Leads, Supervisor and Manager.
- Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously.
- Strong developed organizational and logistic skills. 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.
- Analytical, problem solving, pragmatic and positive critical thinking skills and the ability to act as a change agent to promote flexibility, creativity, and accountability.
- Can do attitude, Right first time and Hands-on approach
- Tenacity to drive issues until resolved and deliver results
- Self-motivated, enthusiastic personality, team player
- Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes
- Self-motivated, enthusiastic personality, team player, with a desire to learn new skills and train juniors
- Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
- A working leader who can participate in supporting activities of production runs
- Strong communication and organizational behaviors skills are required.
- Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
- Proficiency with S4/SAP is a nice to have
- Ability to accommodate shift work including evenings and weekends as required by the process.
- Ability to accommodate unplanned overtime on little to no prior notice
Language(s):
Dutch & 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.
