GMP-SIM- scientist cell therapy

Are you a cell therapy expert with experience in the field of GMP production? Then this is your chance to work in one of the most innovative centers in the Netherlands in the field of Regenerative Medicine & Cell therapy. We are looking for a cell therapy expert with knowledge and experience in the production of complex advanced therapy medicinal products (ATMPs).  

About ICAT uitklapper, klik om te openen

We would like to welcome you to the Innovation Center for Advanced Therapies (ICAT) in Utrecht. With support of the National Growth Fund, the regional infrastructure of the Utrecht Science Park will be expanded with an innovation center that will be part of the Regenerative Medicine Pilot Plant, a RegMed XB infrastructure of 4 leading regenerative medicine clusters in the Netherlands (namely Leiden, Utrecht, Eindhoven and Maastricht). By collaborating with fundamental and translational researchers, GMP experts, analysts and clinicians from different disciplines, new innovative medicines can be translated more quickly into a production process that is suitable for clinical use within ICAT. Moreover, ICAT has the latest biofabrication and cell therapy technology to develop and produce new therapies for clinical applications. Examples of current therapies and concepts are CAR/TCR T cells, stem cells, DCs and biofabricated advanced in vitro models for drug screening and artificial tissues/organs for transplantation. The ICAT consists of three (sub) facilities; a GMP simulation facility, a Biofabrication innovation facility and a GMP production facility. You will be working within the GMP simulation facility on several projects in parallel as part of multiple project teams in close collaboration with the other sub-facilities. 

Job description uitklapper, klik om te openen

As a cell therapy expert, you will be involved in a broad range of tasks: 

• Provide hands-on work in the laboratory to set up complex cell therapy production processes and prepare them for the production under GMP 
• Support the reviewing and writing of (GMP) protocols, e.g., SOPs and Investigational Medicinal Product Dossiers (IMPDs).  
• Act as subject matter expert in cell- and gene therapy 
• Analyse data and prepare reports  
• Contribute to the development and validation of Quality Control assays 
• Contribute to the various projects and setting up the facility in the start-up phase of the ICAT Provide hands-on work in the laboratory to set up complex cell therapy production processes and prepare them for the production under GMP 
• Support the reviewing and writing of (GMP) protocols, e.g. SOPs and Investigational Medicinal Product Dossiers (IMPDs).  
• Act as subject matter expert in cell- and gene therapy 
• Analyse data and prepare reports  
• Contribute to the development and validation of Quality Control assays 
• Contribute to the various projects and setting up the facility in the start-up phase of the ICAT 

Your profile uitklapper, klik om te openen

We are looking for an enthusiastic, flexible and motivated cell therapy expert who can work accurately and independently. You also have: 

• A PhD in a relevant field (life sciences/ pharmacy) and affinity with regenerative medicine and/or gene- and cell therapy or 
• An Msc in a relevant field with a minimum of 5 years relevant work experience with complex cell therapy products, such as CAR/TCR T cells, iPSCs, NK cells or DCs.  
• Hands on experience with and deep knowledge of GMP standards  
• Experience in writing GMP documents such as SOPS 
• Affinity with working in a cleanroom is a plus  
• Full-time available