Quality Control Scientist

King's College London - Gene Therapy Vector Facility

About us

The King’s College London Gene Therapy Vector Facility (GTVF) provides comprehensive GMP-grade viral vector manufacturing services. This includes Lentiviral Vector (LV), Retroviral Vector (RV) and Adeno-Associated Viral Vector (AAV) production for early-phase clinical trials, alongside substantial programmes in process innovation, knowledge transfer & training to address critical skills shortages.

In partnership with the Network of Innovation Hubs, our vision is to ensure that the UK capitalises on its outstanding academic medical research to deliver novel gene therapies to patients, providing transformative treatments for currently intractable conditions, and generating a vibrant economic landscape.

The GTVF is run by a large, industry-leading team of >50 people who have extensive experience in delivering end-to-end viral vector manufacture for both academic & commercial clients, with a focus on early-stage clinical trials. Please note this is a full-time lab-based position.

About the role

The Cell and Gene Therapy, King's (CGT-K) group manufactures a variety of Advanced Therapy Medicinal Products (ATMPs) & starting materials, in state-of-the-art Good Manufacturing Practice (GMP) facilities for treatment of cancer and rare diseases. This post supports the translation of cutting-edge medical research into clinical application. The position is based in a team with an excellent track record in both basic and translational research.

The Quality Control Scientist will be responsible for the carrying out in-house quality control (QC) testing of cell and gene therapy products manufactured by CGT-K group for clinical trials or as starting materials for use in the further manufacturing of ATMPs. Assays will include but not be limited to; flow cytometry-based assays, cell proliferation assays, protein assays and western blots and molecular based methods e.g., qPCR. The role holder will also support the development, validation and establishment of a broad range of state-of-the-art new in-house QC assays and will work with external collaborators on the technical transfer of QC assays into the CGT-K group. The QC Scientist will be responsible for maintaining an inventory of QC samples and will assist with the sending QC samples to external laboratories for testing and ensuring the testing results are received in a timely manner.

The role holder will also play a critical role in conducting immune monitoring studies as part of in-house early phase clinical trials of cell-based immunotherapies.

Testing of in-coming materials & participating in the routine environmental monitoring of the GMP facilities will also form part of the day-to-day activities of the role.

The work carried out by the QC Scientist must be undertaken in compliance with regulatory requirements & quality standards including those of ICH, ISO, GMP and Good Laboratory Practice.

The Quality Control Scientist will be an integral member of the QC team & work with team members across the whole of the Cell and Gene Therapy group including R&D, Production, Technical & Quality Assurance. The QC Scientist will be responsible to the Head of Quality Control.

This position provides an opportunity to develop a good understanding of a wide range of cell and gene therapy product analytical assays and QC testing within the medicines manufacturing field. The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks & responsibilities as may reasonably be expected within the scope and grading of the post.

Please note this is a full-time lab-based position.

This is a full-time (35 hours per week) post, offered on an indefinite contract