Description de l'emploi
The company is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. 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.
As CAR-T Operations Expert, you will be part of the manufacturing operations team responsible for production of CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment. You will lead and perform 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. You will work in a team based, cross-functional environment to complete production tasks required per schedule and drive continuous improvement of manufacturing operations leveraging own observation as well as input of junior team members. As CAR-T Operations expert, you need to build and maintain smooth and strong collaborations with Planning, Manufacturing & Process Technology, QC, Maintenance & Engineering, Facility & Utilities, Warehouse and Quality 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 junior operators on the production floor. You will work in the GMP Facility in Ghent and report to the Operational Manager, Europe.
As CAR-T Operations Expert, you will direct and be part of the daily CAR-T production in a sterile cGMP environment to support clinical and commercial readiness and supply safety policies, quality systems and cGMP requirements. As CAR-T Operations expert, you will act as Operational Ambassador and:
- Support building the GMP documentation package to ensure timely execution of production operations per cGMP compliance
- Execute production activities common to manufacture clinical & commercial grade ATMPs by aseptic manual process, including isolation, selection, activation, transduction, culture, fill and finish and cryopreservation of cells according to SOPs, batch records and aseptic techniques, and record production data and information in a clear, concise, format according to Good Documentation Practices (GDP)
- Work daily in a cleanroom manufacturing environment (Grade A/B/C/D) together with operations personnel on the production floor to provide guidance and perform production tasks as needed to train and help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements
- Manage the daily production planning in a routine production flow.
- Support manufacturing investigations, create/revise operational procedures, including
- manufacturing work instructions, master batch records, forms, and support and manage
- change controls.
- Build strong partnerships with Planning, Manufacturing & Process Technology, QC,
- Maintenance & Engineering, Facility & Utilities, Warehouse and Quality to ensure
- seamless execution of daily production tasks
- Acts as Production Expert in the field by training and coaching junior production technicians by i) being their first point of contact for routine operational activities and
- troubleshooting operational day to day problems and by ensuring that SOPs and good safety practices are followed, and ii) being the second point of contact for production optimizations in collaboration with MS&T team
- Support to Testing and implementation of various manufacturing execution system
- software (e.g. eLiMS, MES, SAP)
- Support the development of manufacturing processes, participate in Lean & Operational excellence projects, and collaborate with MS&T team to drive continuous improvements and efficiencies within CAR-T Operations
- Bachelor’s or Master’s degree in Science, Bio-Engineering, BioTechnology, Pharmacy or related field or equivalent experience required.
- A minimum of 3 years of operations experience within a cGMP or ATMP environment in the biotech/biopharma industry.
- A minimum of 3 years experience in aseptic techniques in clean rooms
- Prior experience in manufacturing, quality, or engineering is required
- Strong influence and relationship building skills with an emphasis on teamwork
- 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
- Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
- Focus on quality, compliance and detail
- Self-motivated, enthusiastic personality, team player, with a desire to learn new skills and train juniors
- Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes
- Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required.
- Experience working in cGMP systems including PASx, eLIMs, Siemens, and SAP is preferred
- Ability to accommodate unplanned overtime on little to no prior notice
- Ability to accommodate changes in the schedule including working in other shifts, evenings and weekends as per operational needs is required.
- Fluent in English and Dutch.