PET Chemistry Operations Manager
This post provides an exciting opportunity for an experienced radiochemist or radiopharmacist to take on a senior role at a leading clinical PET centre, responsible for providing services to >8,000 patients and research participants per year from across South-East London and the wider UK. The Centre is part of both King's College London's School of Biomedical Engineering and Imaging Sciences at the Faculty of Life Sciences and Medicine, and Guy's & St Thomas' National Health Service (NHS) Foundation Trust. The PET Centre’s scanning suites (3 x PET-CT and 1 x PET-MRI system) are critically dependant on a new Good Manufacturing Practice (GMP) Positron Emitting Radiopharmaceutical Laboratory (PERL) facility with 24 hot cells, connected to a PETtrace high energy cyclotron, and an array of dispensing units, calibrators, analysis equipment, and monitoring and management systems.
The PET Centre obtained its MHRA licence for PERL in May 2021, is already producing [18F]fluorodeoxyglucose (FDG) at scale, and are expanding the portfolio by around three new radiotracers per year.
The post holder will be responsible for the operational and logistical management of PERL in three main areas:
• Production of GMP radiopharmaceuticals/radiotracers for daily use (clinical and research)
• Implementation and development of new radiochemistry and labelling methodologies
• Implementation and maintenance of a portfolio of new PET radiotracers
They will supervise teams that include production, QC and QA staff, and will report to the Head of the PET Centre and the School Director of Clinical and Research Imaging Operations. They will work closely with the PET Centre Service Manager, Medical Physics leads, PET Centre clinical and academic leads, and the Trust’s Pharmacy Quality Lead.
Key requirements for this post are the ability to manage all operational aspects of PERL, to ensure (i) reliable supply of radiotracers for clinical use (fulfilling NHS England contract), and (ii) to support a growing portfolio of research activities. The successful candidate will need to have expert knowledge in applicable regulatory governance topics (e.g. Medicines and Healthcare products Regulatory Agency (MHRA), Health and Safety, Environmental Safety, Radiation Protection Regulations), so that they can operate PERL in compliance with these, and actively monitor and report on compliance.
An important criterion for selecting the successful post holder will be their commitment to ensure that radiotracer production and release fully meets the needs of clinical services, whilst also demonstrating drive and vision to grow and support the development of research and new activities.
The post will require on-site attendance at St Thomas’ Hospital and the post holder will be required to work flexibly to meet the needs of the service.
This post will be offered as a permanent contract on a full-time basis.
1. Operate PERL in compliance with applicable regulatory governance (e.g. MHRA, Health and Safety, Environmental Safety, Radiation Protection Regulations), and actively monitor and document compliance with these
2. Lead on the continuing validation, optimal use, and day-to-day smooth running of PERL, including developing and implementing efficient production schedules in conjunction with key stakeholders (Production, QC, QA, R&D, research, scanning/imaging, and medical teams)
3. Manage production, training, and tracer implementation to schedules agreed with Management and within financial and human resource constraints
4. Be accountable for reliable radiotracer production required to fulfil the NHS England contract and other clinical provisions and research agreements
5. In collaboration with the PET Centre Service Manager, line manage the PERL teams to ensure appropriate cover for all activities, and develop, implement, and maintain PERL staff training schedules
6. In collaboration with KCL and Trust Estates & Facilities colleagues, develop, co-ordinate and sustain the PERL facility maintenance programme and schedules, including ensuring contactors, suppliers, service engineers and/or teams perform and document appropriate maintenance of instrumentation and infrastructure
7. In collaboration with the PET Centre senior management team, ensure appropriate financial and human resource management and be accountable for delivery of objectives
8. Troubleshoot and solve logistical and technical problems with key stakeholders in a timely manner, mitigate against any delays, and communicate issues and mitigations effectively
9. Liaise with the research teams using the PERL R&D laboratory to ensure maximum efficiency in usage
10. Proactively develop a positive culture striving for scientific and operational excellence, continuous improvement, staff development / recognition and optimal performance
11. Manage the transition and organise the implementation of new radiochemistries, processes, and tracers into GMP manufacturing for clinical and research use, and contribute to the strategic planning for implementation of new tracers and resourcing / maintaining existing tracers
12. Participate in PET Centre operational, technical and strategic meetings, as well as wider School and Departmental meetings. This will include liaising with the Head of the Imaging Cancer and Biology (ICaB) Department to implement the overarching strategy for the PET Centre.
13. Communicate effectively with pharmacists/QPs, chemists, scientists, clinicians and contractors involved in radiopharmaceutical production and scanning with the tracers produced
The post holder will be required to work collaboratively to deliver the PET Centre’s commitments, but must also be a confident decision maker and able to manage their own time and workload efficiently and effectively. They will require a methodical, flexible, and adaptable approach to work. They will interlink with other areas of the PET Centre and research groups within the School of Biomedical Engineering and Imaging Sciences and will be required to communicate with them effectively.
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. PhD in Chemistry, Pharmacy or related discipline, or equivalent qualification (e.g. through long-term industry experience)
2. Practical experience with the production of PET Radiopharmaceuticals and associated techniques
3. Experience of production to GMP standards
4. Knowledge of PET and/or SPECT radiotracer synthesis, QC and research
5. Knowledge of Ionising Radiation protection regulations
6. Experience with automated synthesis equipment
7. Flexible, personable, and able to work effectively on own initiative and in a multi-disciplinary team
8. Proven ability to lead a team, with a positive, constructive and team-based approach to problem solving
9. Excellent verbal and written communication skills, including ability to provide reports and write operational procedures (SOPs)
10. Flexible approach to hours and duties, in line with service requirements
1. Experience with a range of radionuclides
2. Experience of supporting clinical services
3. Experience of MHRA accreditation processes
Candidates with an existing NHS Pension may choose to remain in that scheme if they wish to do so. Further information will be available via HR
This post is subject to Disclosure and Barring Service and Occupational Health clearance.