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About the Role

The Senior Production/QC Radiochemist will be part of a team of radiochemists involved in the production and/or quality control of radiopharmaceuticals in accordance with GMP requirements.

Main Responsibilities

• Develop new tracers by performing practical validation work as directed by senior radiochemists.
• Support GMP compliance by performing practical validation work and updating SOPs as directed by senior radiochemists.
• Support the training of other staff members, performing routine tasks and administrative work, and acting as the contact with the clinical team when necessary.
• Undertake commissioning, validation, production, and quality control analysis of PET radiotracers in accordance with GMP procedures.
• Carry out practical validation work for development or GMP compliance as directed by a senior radiochemist.
• Perform routine tests, inspections, and maintenance on laboratory equipment and infrastructure.
• Ensure accurate records are maintained of all production, quality control, tests, inspections, and maintenance work in accordance with SOPs.
• Participate in a production and quality control rota system to cover assigned duties by the Production, QC, and Operations manager.
• Comply with local rules for working in a controlled area.
• Follow strict aseptic techniques when working in the isolator hot-cell.
• Communicate technical problems with equipment or processes to other members of the team, cyclotron engineers, clinicians, and senior members of staff.
• Update/write SOPs, logs, and records and investigational reports where necessary or as delegated to ensure they are accurate.
• Schedule their own priorities to ensure that tasks allocated on a daily or weekly basis are completed as required.
• Perform routine administrative tasks such as ordering and recording of materials as directed.
• Be trained on and apply syntheses/analytical methods for newly introduced radiotracers for research and clinical GMP use.
• Train other staff, researchers, or students in production or quality control processes as required.
• In the occasional non-availability of senior staff, act as the point of contact between the PET production/QC team and the clinical team as appropriate.
• Will actively engage with staff training programmes and be competent to perform at least three different GMP manufacturing processes on different synthesis platforms.
• Will actively engage with production staff training and be competent to operate the hot-cells, automated synthesis platforms, and dispensing platforms.
• Will actively engage with QC staff training programme and be competent to operate all of the QC equipment in the laboratory (including automatic injection HPLC, MCA detector, GC, TLC, etc., PTS) for GMP radiotracer productions.
• After appropriate training, be able to operate the PET Trace Cyclotron for production of radionuclides to be used in synthesis processes.
• Raise Quality Exception Reports as required such as Occurrences, Deviations, Change Controls.
• Will raise Quality Exception Reports and investigate quality exceptions including completing Root Cause Analyses and drafting Quality Exception Reports for approval by QA.

About Us

The PET Centre is part of Guys and St Thomas NHS Foundation Trust and Kings College London within the School of Biomedical Engineering & Imaging Sciences.

The Positron Emitting Radiopharmaceutical Laboratory (PERL) plays a crucial role in the clinical PET Centre, serving over 8,000 patients and research participants annually from South-East London and beyond.

It is an integral part of both King's College London's School of Biomedical Engineering and Imaging Sciences and Guy's & St Thomas' National Health Service (NHS) Foundation Trust.

Our PET Centre relies heavily on the PERL facility for the supply of radiopharmaceuticals and this is likely to become increasingly important when the new Total Body PET scanner is installed later this year.

Comprising two GMP clean rooms, a QC laboratory, and an R&D laboratory with a total of 24 hot cells, the PERL facility is equipped with a PETtrace high-energy cyclotron and various dispensing units, calibrators, and analysis equipment.

It operates under a Specials manufacturing license, currently producing [18F]fluorodeoxyglucose (FDG) and [11C]methionine routinely, with ongoing development of additional radiotracers.

We anticipate the availability of two more radiotracers for routine and research use by the end of 2024, with plans to expand the portfolio by two to three radiotracers annually.