CAR-T Operations Technical Lead Clean Room
CAR-T Operations Technical Lead Clean Room
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.
The CAR-T Operations Supervisor is an exempt level position working within Technical Operations team, responsible for directing the daily production of 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
You will work in the GMP Facility in Ghent and report to the Operational Manager, Europe.
The CAR-T Operations Supervisor will lead and supervise multiple units within the CAR-T process operations (i.e. component preparation manufacturing, manufacturing support operations, CAR-T process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements.
The CAR-T Operations Supervisor will need to build strong partnerships with Manufacturing Operations, QC IPC Operations, Quality, Facilities & Engineering, MS&T/Manufacturing Excellence, Training, Planning, Procurement & Supply Chain / Warehouse to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for technicians and experts on the production floor.
Be the SME for Quality aspects related to Production activities:
Coordinate, manage and control all quality aspects related to production activities and production of batches in cGMP areas:
Manage and review in a timely manner « documentation » activities in Production zones (incl. Procedures, work instructions, logbooks, transfer forms…)
Edition and review of executed batch records (paper doc & MES)
Conduct routine and non-routine (spot checks) inspection on documentation in the production zones
Write or revise and control in a timely manner production-related QMS documentation (in line with cGMP) in collaboration with MS&T and Quality:
Change Control Requests (CCR), Deviations/events, and CAPA
Master Batch Records of products and preparations, SOPs and associated documents, cleaning validation, shut down and media fill simulation protocols and reports
Review cGMP documents generated by the Production for technicians and experts before review by QA
Manage and communicate KPIs related to quality aspects in Production
Production SME for internal & GMP inspections in collaboration with QA (back-up of Operations manager):
2nd point of contact representing Production quality matters in external audits
First-line communication with QA Ops for quality matters, and responsible to escalate production-related matters out of their empowerment zone to ensure timely decision and follow-up
Be the SME for Production aspects related to CAR-T Products and Processes:
Work closely with operations personnel on the production floor 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 to the Tech Transfer plan for new production introduction or process optimization, led by MS&T/Manufacturing Excellence (Engineering runs & PPQ runs), including definition of needs, risk assessment, execution and readiness for clinical & commercial
Support the development of manufacturing processes, participate in various department projects, and will work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations.
Support to the qualification/validation plan of new materials, consumables and equipment, led by MS&T/Manufacturing Excellence, including definition of needs (URS) and implementation.
Support to drug product investigations (including batch failures)
Participate in the training to the different manufacturing processes (product manufacturing steps and preparations)
Manage and communicate KPI’s related to output in Production
Production Organization and capabilities, people management:
Lead the daily start of shift operations meetings, the daily wrap-up production meetings and assign individuals their daily production task to execute and ensure compliance and successful completion of work-related tasks
Organize and supervise trainings together with Training
Work closely with Operations Manager to help oversee the development of production personnel and provide input on personnel performance
Support Budget monitoring and control of production-related cost center expenses in close cooperation with the Ops Manager / Head of Operations
Quality and EHS Risk assessment on production activities, including zones and flows, equipment, materials and consumables, and data assessment
Support to the design, specifications, construction, qualification & validation, and regulatory approval of Production capabilities
Identification of issues and continuous improvement initiatives for the production operations and areas
Support to Alarm management of the production zones, in collaboration with Maintenance/Engineering and Facility
Manage sterilization of materials and documents
Support to Monitoring the Production areas, incl QC Environmental control in collaboration with Maintenance/Engineering, QC and Facility
Manage inventory in the production zones, as support to Procurement & Supply Chain / Warehouse
Ensure safe and compliant manufacturing operations according to EHS and cGMP procedures and requirements
Work in a constructive and flexible way in a team
Follow up of training status of production personnel
REQUIREMENTS / QUALIFICATIONS
Bachelor’s or Master’s degree in Science, Bio-Engineering, Pharmacy or related field or equivalent experience required.
A minimum of 5 years of operations experience within a cGMP or ATMP environment in the biotech/biopharma industry.
At least 3 years of aseptic GMP manufacturing experience (grade A/B or C).
Capabilities, Knowledge, and Skills:
Knowledge of cGMP regulations and EMEA guidance related to manufacturing of cell-based products, and cleanroom behaviors.
Must exhibit strong Leadership skills and ability to effectively communicate and influence Operations associate and convey information to Management.
Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
Highly developed organizational 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.
Strong analytical, problem-solving, pragmatic and positive critical thinking skills and the ability to lead 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
An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
Experience with Operational Excellence and/or Lean Manufacturing is an asset.
A working leader who can participate in production runs in critical situations when needed.
Excellent communication and organizational behaviors skills are required.
Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
Proficiency with MES/EBR 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