Project Leader QC Cellular Therapies

The Project Leader QC Cellular Therapies will join the Quality Control (QC) laboratory of the Hospital Pharmacy of the Netherlands Cancer Institute. Our work and research are focused on the development of assays to characterize T cell Advanced Therapy Medicinal Products (ATMPs) and assays for QC testing of these cellular drug products. The QC laboratory works in close collaboration with the production department of the Hospital Pharmacy (BioTherapeutics Unit, BTU) where the cellular drug products are manufactured, and the division of Molecular Oncology & Immunology (group of John Haanen), involved in the development and clinical application of novel cellular products. 

Role description
Adoptive cell transfer (ACT) of autologous T cell products is a novel treatment option for cancer patients. Recent developments in the CAR-T cell field have demonstrated the potential of ACT in patients with hematological malignancies. In the field of solid oncology, adoptive cell therapy with Tumor Infiltrating Lymphocytes (TIL) is successfully being applied in patients with metastatic melanoma, and trials testing the feasibility of TIL, CAR-T and T-cell receptor (TCR)-engineered T cell products are ongoing for different cancer types. In our institute, we have an active ACT program, including a phase III randomized controlled clinical trial with TIL in patients with metastatic melanoma, we finalized a phase Ib/II study with TCR-engineered T cells for patients with metastatic melanoma and we are currently bringing two novel types of fully personalized, neo-antigen directed, TCR-engineered T cell therapy towards clinical application. As such, NKI is one of the few centers in Europe with ample experience with ACT and is currently playing a leading role in this field of research. We aim to further develop and expand this ACT program over the next years within the NKI/AVL Center for Cellular Therapy.

Recently, the Dutch Cancer Society (KWF Kankerbestrijding) funded a large infrastructural project aiming at the development of a Dutch platform for cancer-specific ATMP Research to ensure harmonized development, clinical testing and sustained patient access (DARE-NL). As leader of the DARE-NL work package on QC harmonization and assay development, we are expanding our QC laboratory to develop state-of-the-art assays for the characterization and QC analysis of cellular drug products according to Good Manufacturing and Good Laboratory Practice (GMP/GLP) and to harmonize between academic ATMP production centers. Therefore, we are looking for a Project Leader within the QC department who will be responsible for the development, validation and performance of assays for identification (Flow cytometry (FACS), sequencing), sterility (BacT/Alert, Endosafe, qPCR), potency (ELISA, FACS, next generation sequencing), and characterization (FACS, next generation sequencing (incl. single cell seq), ddPCR) of T cell products (final release and in process controls). In the future we aim to expand the team with at least one technician who will work together with the Project Leader QC cellular therapies. 

You will be responsible for development, validation design, documentation of the validation (plan, protocol and report), execution of the experiments, analysis of samples, interpretation of data, the identification of appropriate follow up strategies and reporting of these activities. You will also be involved in the development of GMP processes, QC testing methods and clinical trial applications, together with the other members of our multidisciplinary team.