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Senior Radiochemist

2 months ago

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

We are seeking a highly skilled Senior Production/QC Radiochemist to join our team at the PET Centre, part of Kings College London. As a key member of our radiochemistry team, you will be responsible for the production and quality control of PET radiopharmaceuticals in accordance with GMP requirements.

Key Responsibilities
  • Develop and implement new tracers by performing practical validation work and updating SOPs as directed by senior radiochemists.
  • Support GMP compliance by performing practical validation work and updating SOPs as directed by senior radiochemists.
  • Train other staff members, perform routine tasks, and act as the contact with the clinical team as needed.
  • Undertake commissioning, validation, production, and QC analysis of PET radiotracers in accordance with GMP procedures.
  • 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.
  • 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 as necessary.
  • Schedule their own priorities to ensure tasks are completed as required.
  • Perform routine administrative tasks 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.
  • Act as the point of contact between the PET production/QC team and the clinical team as needed.
  • Engage with staff training programs and be competent to perform at least three different GMP manufacturing processes on different synthesis platforms.
  • Engage with Production staff training and be competent to operate the hot-cells, automated synthesis platforms, and dispensing platforms.
  • Engage with QC staff training program and be competent to operate all of the QC equipment in the laboratory for GMP radiotracer productions.
  • Operate the PET Trace Cyclotron for production of radionuclides to be used in synthesis processes after appropriate training.
  • Raise Quality Exception Reports as required.
Person Specification

Knowledge and Skills

  • Knowledge of and proven record in adhering to the principles of GLP and GMP.
  • Ability to amend documents, e.g., 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.

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.