Robin Van Meldert
Business Unit Manager
+32 476 51 85 87
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.
We 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.
As Operations Technician, you will be part of the Core Operations Team, responsible for directing the daily CAR-T operations and production to timely support clinical and commercieal readiness and commercial CAR-T prodcut supply. You will be performing the daily manufacturing operations within a sterile cGMP enviroment.
- Manufactures clinical & commercial grade ATMPs by aseptic manual process, including isolation, selection, activation, transduction, culture, fill an finisch and cyropreservation of cells. This according to SOPs and aseptic techniques. Record production data and information in a clear, concise, format according to GDP (Good Documentation Practices).
- Works daily in a cleanroom manufacturing environment (Grade A/B/C/D).
- Performs operational tasks on time in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Controls and maintains the environment (equipment & facility cleaning and environmental monitoring) of the GMP production areas
- Keeps equipment operating by following operating instructions, troubleshooting breakdowns and calling for repairs
- Contributes to activities related to processes optimization, and introduction of new procedures, products and equipment in GMP areas
- Provides support to writing and revising SOPs and associated documents (incl. batch records, work files, checklists, procedures) related to routine Production documentation.
- Communicates clearly with the Ops Manager and Operational SMEs to highlight on production status or any items related to safety, quality and efficiency
- Uses various manufacturing execution systems (e.g. eLiMS, MES, SAP), and supports to testing and implementation of these.
- Works in a constructive and flexible way in a team based, cross-functional environment.
- A minimum of 1 year hands on operations experience within a cGMP or ATMP environment in the biotech/biopharma industry is preferred.
- Graduate, Bachelor’s or Master’s degree in Science, Bio-Engineering, BioTechnology, Pharmacy or related field or equivalent experience required.
- Minimum 1 year hands-on experience in aseptic techniques in clean rooms is preferred.
- Knowledge of GMP is preferred.
- Strong influence and relationship building skills with an emphasis on teamwork.
- Experience in manufacturing, maintenance, quality, testing, or engineering areas is preferred.
- 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.
- 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.
- Ability to work in (transversal) teams - Team spirit.
- Self-motivated, enthusiastic personality, team player, with a desire to learn new skills.
- 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.
- 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..
- Experience working in cGMP systems including PASx, eLIMs, Siemens, and SAP is preferred.
- Fluent in English and Dutch.