Senior Production/QC Radiochemist

1 week ago

London, Greater London, United Kingdom Kings College London Full time
About the Role

We are seeking a highly skilled and experienced Senior Production/QC Radiochemist to join our team at the PET Centre, part of Guys and St Thomas NHS Foundation Trust and Kings College London within the School of Biomedical Engineering & Imaging Sciences.

Main Responsibilities
  • Develop new tracers by performing practical validation work as directed by more senior radiochemists.
  • Support Good Manufacturing Practice (GMP) compliance by performing practical validation work and updating Standard Operating Procedures (SOPs) as directed by more senior radiochemists.
  • Support the training of other staff members, performing routine tasks and administrative work and acting as the contact with the clinical team on occasions when the need arises or is assigned to.
  • Undertake commissioning, validation, production and quality control (QC) 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, QC, tests, inspections and maintenance work in accordance with SOPs.
  • Participate in a production and QC rota system to cover assigned tasks 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 to senior members of staff.
  • Update/writing SOPs, logs and records and investigational reports where and when necessary or as is 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 QC 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 (various detectors DAD, Conductivity, ECD) 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.
  • 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 Quality Assurance.
Person Specification

Knowledge and Skills

  • Knowledge of and proven record in adhering to the principles of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
  • Ability to amend documents such as SOPs.
  • Excellent verbal and written communication skills.
  • Excellent time keeping, reliability, flexibility and ability to work with a variety of people with a flexible approach to hours and duties and ability to work on own initiative and in a multi-disciplinary team.

Experience

  • Knowledge of PET radiotracer synthesis and QC.
  • Radiochemistry/radiopharmacy laboratory experience.
  • Practical experience with the production and/or QC of PET Radiopharmaceuticals.

Desirable

  • Knowledge of Ionising Radiation protection regulations.
  • Experience with automated synthesis equipment.
  • Experience of production to GMP standards.

Qualifications

  • Degree in chemistry or pharmacy OR Broad vocational experience, acquired through a combination of job-related vocational training and considerable on the job experience, demonstrating development through involvement in a series of progressively more demanding relevant work/roles.

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