Senior Radiochemist

2 weeks ago


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

About the Role

The Senior Production and Quality Control Radiochemist will play a key role in the production and quality control of radiopharmaceuticals 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.

Key Responsibilities

  • Develop and implement 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 as needed.
  • Undertake commissioning, validation, production, and 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 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 and write SOPs, logs, and records and investigational reports as necessary or as delegated.
  • 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, 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.

Person Specification

Knowledge and Skills

Essential

  • Knowledge of and proven record in adhering to the principles of GLP and GMP.
  • Ability to amend documents eg SOPs.
  • Excellent verbal & written communication skills.
  • Excellent time keeping, reliable, Flexible and able to work with a variety of people with a Flexible approach to hours & duties and ability to work on own initiative and in a multi-disciplinary team.

Experience

Essential

  • 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

Essential

  • 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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