CAR-T Operations Technical Lead Clean Room

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 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.

RESPONSIBILITIES

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

• Support to:

• 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

Education

• Bachelor’s or Master’s degree in Science, Bio-Engineering, Pharmacy or related field or equivalent experience required.

Experience

• 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