Postdoctoral Research Associate
Working under the supervision of Professor Anthony Dorling, in the Department of Inflammation Biology at KCL and Sakina Gooljar, Head of Advanced Therapy Production at the 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 ATMP manufacturing process for GAMECHANgER project. 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 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, that you will co-supervise with the PI. In this position you will develop strong working relationships with the chief investigator, senior trial manager, BRC staff, other academics, principle investigators, consultants, nursing staff, researchers and healthcare scientists.
This post will be offered on a fixed-term contract until 30th September 2024.
This is a full-time post - 100% full time equivalent
• In the Department of Inflammation Biology (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.
• Maintain up-to-date, accurate and comprehensive laboratory notes
• Perform and supervise the experimental immunomonitoring programme on patient samples allied to the GAMECHANgER clinical trial
• Assist, supervise and train other members of the group, including students and other research staff in experiments design, assembling new setups and equipment, data acquisition and data analysis methods.
• Actively participate in activities, duties and rotas.
• In the BRC Unit:
• Responsible for delivering a highly specialist clinical technical service by executing the manufacturing of Treg product within the BRC Unit for participants enrolled in the GAMECHANgER clinical trial.
• Ensure manufactured products are labelled, documented and stored according to authorised specifications and quality standards.
• Assess suitability of human cells received for manufacture and liaise with senior clinical staff for action or advice if unsuitable. You will ensure the correct disposal of cells and/or patient samples in accordance with relevant departmental and governmental policies.
• 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 Unit’s capacity planning system to ensure smooth running within the BRC Unit.
• Work unsupervised in managing production deviations, making informed decisions relating quality systems. You will independently undertake specialist Validation and Qualification for the GMP Unit facilities and equipment as delegated by the Head of Advanced Therapy Production.
• 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.
• Exercise strategic thinking and judgements based upon specialist knowledge of the manufacturing process, operating within the boundaries of the Pharmaceutical Quality Systems (PQS), such as: how to proceed during technical failures; PPM; Quality Control assessments; technical decisions; suitability of material for manufacture; analysis of anomalous results.
• Qualify, validate and re-validate equipment and GMP procedures successfully and on-schedule according to the Unit’s Validation Master Plan (VMP) and PQS, and assist in the implementation and development of new techniques and equipment.
• Monitor and control the production environment to ensure that standards of cleanliness and hygiene are maintained.
• 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. Hands-on experience operating in an aseptic GMP Unit manufacturing ATMPs will provide you with the skills to meet these developing needs.
• To ensure production process are fully within the unit’s quality management system including the use of QPulse and its application for the management of document control and to support its use throughout the department.
• Work to unit-specific SOPs and policies relating to and manufacturing operations that comply with GMP and the Unit’s manufacturing licence.
• Product-specific SOPs and batch-specific documentation for the manufacture of ATMPs.
• Product Specification Files or Preparation Process Dossiers for cell therapies.
• Undertake documentation control procedures, using database systems to track GMP documentation. You will work autonomously to Standard Operating Procedures and protocols. 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.
Communication and networking
• Using your well-developed organisational and communication skills you will actively work independently and as part of a team of clinicians, scientists and regulatory personnel.
• You will 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.
• Prepare manuscripts for publication in peer review journals
• Facilitate collaboration and networking which engages and supports the activities of this research.
Decision making, planning and problem solving:
• Contribute to collaborative decision making with colleagues in area of research
• Deal with problems which may affect the achievement of research objectives and deadlines
• Implement new technological approaches to solve problems
• Contribute to decisions affecting the work of the team
• Take initiative to undergo relevant training
Analysis and Research:
• Write up research work for publication in scientific journals
• Continually update knowledge and understanding in field
• Translate knowledge of advances in the subject area into research activity
• Analyse and interpret research data and draw conclusions on the outcomes.
Teamwork and learning support:
• Actively participate as a member of the research team in DIB.
• Attend and contribute to relevant meetings in DIB and BRC Unit.
• Provide mutual support to the team, acting as a role model of good practice.
• Set up and maintain relevant laboratory equipment for use by self and others.
• Supervise the research activities of undergraduate and postgraduate students engaged in related research under the direction of the group leaders.
Sensory/physical demands and work environment:
• Balance with help the competing pressures of research and administrative demands and deadlines within the DIB and BRC Unit.
• Be aware of the risks in the work environment and their potential impact on own work and that of others.
• Provide day-to-day professional supervision and practical training for production activities and ongoing supervision of support staff, and new and junior staff.
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
1. BSc in Biology, Biomedical Sciences or related areas AND
PhD awarded in Immunology, Immunogenetics or related areas, or PhD near completion
2. Evidence of training in principles of human cell culture, particularly involving T cell and B cell biology Intercalated BSc
3. Sound knowledge of research methodology including clinical trials
4. Ability to successfully manage tasks to a deadline and to work calmly under pressure and show good organisation skills
5. Ability to analyse problems and proactively identify solutions
6. Human cell manipulation and processing for clinical trials, Immunomonitoring techniques, preferably including ELISPOT or similar, isolation of human peripheral blood mononuclear cells and assessment of viability, phenotype and function, primary cell culture, immunomagnetic depletion, FACS and proliferation methods
7. Experience in writing scientific reports and evidence of intellectual contribution to research through publication records including leading peer-reviewed scientific journals
8. Organised and systematic approach to research, with evidence of excellent record keeping / attention to detail
9. Strong work ethic, evidence of initiative and proactivity combined with willingness to learn and develop new skills
10. Ability to work independently and as part of a team, self-motivated, with the ability to work under pressure & to meet deadlines
11. Excellent interpersonal skills
12. Ability to think strategically combined with ability to make collaborative and independent decisions
13. Ability to contribute to the team success (training colleagues, providing scientific input during meetings, keeping a healthy working atmosphere in the lab)
1. GCP and/or GMP certification
2. Sound knowledge of clinical trials
3. Knowledge of ATMPS
4. Operating in an aseptic GMP Unit manufacturing ATMPs including closed cell processing
5. Experience of following standard operation procedures and documenting progress of allocated tasks
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.