Working under the supervision of Professor Anthony Dorling, in the Department of Inflammation Biology (DIB) at King’s College London (KCL) and Arindam Mitra, Head of Advanced Therapy Production at the NIHR BRC Unit, Guy’s Hospital, the post holder with their experience and specialist knowledge in Good Manufacturing Practice (GMP) and immune cell culture will take responsibility for delivering ATMPs for GAMECHANgER. This is an early phase ATMP clinical trial.
Specifically, the post holder will be responsible for planning, directing and executing the production of T regulatory cell (Treg) product for participants enrolled in GAMECHANgER and will also be responsible for conduct of immunomonitoring experiments on participant samples collected during the follow up phase of the trial. There will be a research assistant appointed to work alongside the successful applicant. You will co-supervise this research assistant with the Professor Dorling and liaise directly with the Senior Trial Manager, Dr Leanne Gardner.
In this position you will have the unique opportunity to work on a ground-breaking cell therapy trial and develop strong working relationships with the chief investigator, senior trial manager, BRC staff, other academics, principle investigators, consultants, nursing staff, researchers and healthcare scientists. You will also actively interpret data, contribute to discussions and prepare reports on results for verbal and multimedia presentations at regular lab meetings, departmental seminars, national and international meetings. You will also, prepare manuscripts for publication in peer review journals. There will also be the opportunity to implement new technological approaches to solve problems and undergo relevant training as required.
About the Faculty
About the School of Immunology & Microbial Sciences
Department of Inflammation Biology
This post will be offered on a fixed-term contract for 3 years and 5 months.
This is a full-time post.
The two key responsibilities for this post include delivering a highly specialist clinical technical service in the BRC Unit by executing the manufacturing of Treg product for participants enrolled in the GAMECHANgER clinical trial and performing/supervising the experimental immunomonitoring programme for patient samples from the enrolled clinical trial participants in the DIB.
Manage the progress and set goals for achievement of project aims in collaboration with the chief investigator and senior trial manager including the execution of literature reviews, data collection and analysis, and report preparation.
Ensure that all GMP 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. Hands-on experience operating in an aseptic GMP Unit manufacturing ATMPs will provide you with the skills to meet these developing needs.
Produce the IMPD, Product Specification Files and/or Preparation Process Dossiers for cell therapies in addition to preparing product-specific SOPs and batch-specific documentation for the manufacture of ATMPs.
Work unsupervised in managing production deviations and implementing changes, making informed decisions relating to quality systems. You will independently undertake specialist Validation and Qualification for the GMP Unit facilities and equipment.
Plan and prioritise the use of specialist GMP equipment workload, liaising with other departments, and suppliers in relation to manufacturing ATMPs. You will interact with the BRC Unit’s capacity planning system to ensure smooth running within the Unit.
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. You will ensure adequate maintenance and supervision of equipment and ensure compliance with Planned Preventive Maintenance (PPM), coordinating with company engineers to maximize the correct operation of essential equipment.
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.
Undertake documentation control procedures, using database systems to track GMP documentation. You will work autonomously to Standard Operating Procedures and protocols. Keep accurate and up to date written and electronic records of all work undertaken.
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
- PhD awarded inImmunology, Immunogenetics or related areas, orPhD near completion.
- BSc in Biology, Biomedical Sciences or related areas
- Knowledge of T cell and B cell biology
- Evidence of training in principles of human cell culture
- Experience of human cell isolation, manipulation and processing for clinical trials including closed cell processing, assessment of viability, primary cell culture, immunomagnetic enrichment, flow cytometry, proliferation methods and immunomonitoring techniques, preferably including ELISPOT
- Operating in an aseptic GMP Unit manufacturing ATMPs
- Experience of following standard operation procedures and documenting progress of allocated tasks
- Evidence of intellectual contribution to research through publication records including leading peer-reviewed scientific journals
- Proficiency with word processing and data collection packages (e.g., Word, Excel, Access)
- Ability to successfully manage tasks to a deadline and to work calmly under pressure.
- Ability to think strategically, analyse problems and proactively identify solutions
- Excellent record keeping / meticulous attention to detail
- GCP and/or GMP experience
- Sound knowledge of clinical trials
- Ability to contribute to the team success (training colleagues, providing scientific input during meetings, keeping a healthy working atmosphere in the lab)
- Sound knowledge of research methodology and clinical trials
- Experience in writing scientific reports
*Please note that this is a PhD level role but candidates who have submitted their thesis and are awaiting award of their PhDs will be considered. In these circumstances the appointment will be made at Grade 5, spine point 30 with the title of Research Assistant. Upon confirmation of the award of the PhD, the job title will become Research Associate and the salary will increase to Grade 6.