We are looking for a highly motivated Research Assistant to work on GAMECHANgER, an early phase ATMP clinical trial being run by Professor Anthony Dorling at King’s College London (KCL). You will be co-supervised by Professor Dorling and a Senior Research Associate working on the project. You will also report to Arindam Mitra, Head of Advance Therapy Production at the NIHR BRC Unit, Guy’s Hospital, and liaise on a regular basis with the Senior Trial Manager, Dr Leanne Gardner.
Specifically, the main responsibility of the post holder will be to assist with performing immunomonitoring experiments on participant samples collected during the follow up phase of the GAMECHANgER trial. These experiments will be performed in the Department of Inflammation Biology (DIB), at KCL. In addition, the post holder will also be trained in and assist with the manufacture of T regulatory cell (Treg) product for participants enrolled in the trial. Treg cell production will take place in the BRC Unit, Guy’s Hospital.
In this position, you will have the unique opportunity to work on a ground-breaking cell therapy trial for which, you will have a substantial role in the laboratory analysis of clinical trial samples whilst also gaining experience of GMP production of cell therapy product for GAMECHANgER participants.
About the Faculty
About the School of Immunology & Microbial Sciences
Department of Inflammation Biology
This post will be offered on an a fixed-term contract for 3 years and 5 months.
This is a full-time post.
- In the DIB, you will perform immunomonitoring assays on patient samples from the GAMECHANgER clinical trial, under supervision of a post-doctoral research associate.
- Assist with managing the progress for achievement of project aims in collaboration with the chief investigator, research associate and senior trial manager.
- Liaise with the senior trial manager, research nurses and clinicians regarding participant sample collection.
- Assist with the manufacturing of Treg product within the BRC Unit for participants enrolled in the GAMECHANgER clinical trial.
- Ensure manufactured Treg products are labelled, documented and stored according to authorised specifications and quality standards.
- Undertake safe use of production laboratory equipment, maintain, operate, and clean the GMP Unit facilities and equipment in compliance with Unit’s stated procedures and standards.
- Ensure that all products are manufactured and stored according to appropriate rules and guidelines so that they are fit for their intended use regarding safety and quality. You will undertake specialist tests to maintain quality standards while in production.
- Work to unit-specific SOPs and policies relating to and manufacturing operations that comply with GMP and the Unit’s manufacturing licence.
- Undertake documentation control procedures, using database systems to track GMP documentation. You will work autonomously to Standard Operating Procedures and protocols and keep accurate written and electronic records of all work undertaken.
- Work in compliance with national standards for the safe, secure and confidential processing and storage of patient and laboratory information and when accessing patient information on computer databases.
- Actively participate in general activities, ordering, other duties and rotas of the Transplant Inflammation and Repair Lab and BRC ATP production unit.
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
Skills, knowledge and experience
- BSc in Biology, Biomedical Sciences or related areas
- Knowledge of T cell and B cell biology
- Experience of human cell manipulation and processing clinical use and/or working in a clean room
- Experience of the isolation of human peripheral blood mononuclear cells and assessment of viability, phenotype and function.
- Experience of immunomonitoring techniques, preferably including ELISPOT or similar and multicolour flow cytometry
- Experience of following standard operation procedures and documenting progress of allocated tasks
- Excellent record keeping / meticulous attention to detail
- Strong work ethic, evidence of productivity
- Excellent interpersonal skills
- Excellent organisation skills and IT skills
- Ability to work independently and as part of a team
- Self-motivated, with the ability to work under pressure and meet deadlines
- MSc in Immunology, Haematology or related areas
- GCP and/or GMP experience
- Knowledge of research methodology and/or clinical trials
- Experience in Good Manufacturing Practice (GMP), preferable in an aseptic GMP Unit manufacturing ATMPs
- Willingness to learn, develop new skills and be flexible when required
This post is subject to a Occupational Health Clearance and a Disclosure Barring Service.