Senior Production/QC Radiochemist Specialist

1 week ago

London, Greater London, United Kingdom Kings College London Full time

About Kings College London

Kings College London is a world-leading research university with a rich history and commitment to innovation. Our research has real-world impact, improving lives locally and globally.

We are seeking an exceptional Senior Production/QC Radiochemist to join our team at the PET Centre, which plays a crucial role in the clinical PET Centre, serving over 8,000 patients and research participants annually from South-East London and beyond.

As a Senior Production/QC Radiochemist, you will work as part of a team of radiochemists involved in the production and/or QC of radiopharmaceuticals in accordance with GMP requirements to set production schedules.

Key Responsibilities:

  • Commissioning, validation, production, and QC analysis of PET radiotracers in accordance with GMP procedures;
  • Practical validation work for development or GMP compliance as directed by a senior radiochemist;
  • Routine tests, inspections, and maintenance on laboratory equipment and infrastructure;
  • Maintaining accurate records of all production, QC, tests, inspections, and maintenance work in accordance with SOPs;
  • Participating in a production and QC rota system to cover assigned duties by the Production, QC, and Operations manager;
  • Complying with local rules for working in a controlled area;
  • Following strict aseptic techniques when working in the isolator hot-cell;
  • Communicating technical problems with equipment or processes to other members of the team, cyclotron engineers, clinicians, and senior members of staff;
  • Updating/writing SOPs, logs, and records and investigational reports where necessary or delegated to ensure they are accurate;
  • Scheduling their own priorities to ensure that tasks allocated on a daily or weekly basis are completed as required;
  • Performing routine administrative tasks such as ordering and recording of materials as directed;
  • Being trained on and applying syntheses/analytical methods for newly introduced radiotracers for research and clinical GMP use;
  • Training other staff, researchers, or students in production or QC processes as required;
  • In the occasional non-availability of senior staff, acting as the point of contact between the PET production/QC team and the clinical team as appropriate;
  • Actively engaging with staff training programs and being competent to perform at least three different GMP manufacturing processes on different synthesis platforms;
  • Actively engaging with Production staff training and being competent to operate the hot-cells, automated synthesis platforms, and dispensing platforms;
  • Actively engaging with QC staff training program and being 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, being able to operate the PET Trace Cyclotron for production of radionuclides to be used in synthesis processes;
  • Raising Quality Exception Reports as required such as Occurrences, Deviations, Change Controls;
  • Raising Quality Exception Reports and investigating quality exceptions including completing Root Cause Analyses and drafting Quality Exception Reports for approval by QA.

The salary for this position is estimated to be around £45,000 - £60,000 per annum, depending on experience. The successful candidate will have a degree in chemistry or pharmacy, or broad vocational experience demonstrating development through involvement in a series of progressively more demanding relevant work/roles. Experience with PET radiotracer synthesis and QC, radiochemistry/radiopharmacy laboratory experience, and practical experience with the production and/or QC of PET Radiopharmaceuticals are also essential. Knowledge of Ionising Radiation protection regulations, experience with automated synthesis equipment, and experience of production to GMP standards are desirable.

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