Quality Control - Cellular Therapies

Function description

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 is 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) with autologous T cells 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 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 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.

Currently, we are expanding our QC laboratory (working according to Good Manufacturing Practices (GMP) regulations) to include the characterization and QC analysis of cellular drug products. Therefore, we are looking for a Project Leader within the QC department who will be responsible for the development of assays for identification (Flow cytometry, sequencing), sterility (BacT/Alert, Endosafe, qPCR), potency (ELISA, FACS) and the analysis of incoming samples. In the future we aim to expand the team with a 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.