PhD Candidate Regulation and Development of an iPSC-derived Beta Cell Medicinal Product

Are you ambitious and interested in drug development and cell & gene therapies? Would you like to contribute to the development, manufacturing and quality testing of iPSC-derived beta cells and bring this product to the clinic? Then we would like to meet you!

Who We Are    

The Center for Cell & Gene Therapy (CCG) is a research facility within the LUMC and has more than 20 years of experience in the development and production of cell and gene therapies. You will work in a team of approximately eight employees who are involved in the production and development of innovative medicines, including cell and gene therapies. In addition, you will actively collaborate with the research group developing the iPCS-derived beta cell product. Within the CCG we support the researchers in product development and we are responsible for production in our GMP facility. In addition, we are a center of expertise in the field of regulations for this group of medicines. As a research facility for the LUMC we have multiple interactions and close collaborations with research groups and stakeholders within and outside the LUMC. 

You will also be part of reNEW Leiden. reNEW is an international research center focused on stem cell research and the translation from lab to clinic. Within this consortium we work together with reNEW Copenhagen (University of Copenhagen, Denmark) and reNEW Melbourne (Murch Children’s Research Institute, Australia). There are around 240 employees working for reNEW Leiden, mainly in the laboratories. 

Job description    

As a PhD candidate you will contribute to the development of iPSC-derived beta cells for clinical use. The iPSC-derived beta cell product is at the forefront of innovation and you will focus on the specific challenges related to that during drug development. You will define safety and efficacy parameters and how to translate these in quality release testing of the product. Safety of the islet cell product will be of primary importance, and dedicated assays will be developed within this project. You will also investigate how the product fits int the regulatory framework, develop a regulatory roadmap and define the impact of regulation on product development. 

About you

  • You have a master’s degree in (bio)medical sciences, (bio)pharmaceutical sciences, pharmacy, or a related scientific discipline. 
  • You have a demonstrable interest and preferably some experience in drug development and cell & gene therapy. 
  • You must be fluent in English, possess good communication skills and writing skills. In addition, the ability to collaborate with experts from different disciplines is essential. 
  • You have the ability to work independently as well as in a team and to take initiative in research projects. 
  • You work structured and accurately. 

Application close: 7 August 2023

Interested and want to learn more about this position please follow the below link.