Senior Production/QC Radiochemist

2 weeks ago


London, Greater London, United Kingdom NHS Full time
About the Role

The Senior Production/QC Radiochemist will be a key member of our team, responsible for the production and quality control of radiopharmaceuticals in accordance with Good Manufacturing Practice (GMP) requirements.

Key Responsibilities
  • Commissioning, validation, production, and quality control 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, quality control, tests, inspections, and maintenance work in accordance with Standard Operating Procedures (SOPs).
  • Participate in a production and quality control rota system to cover 05:00 to 18:30 as assigned by the Production, Quality Control, and Operations manager.
  • Comply with local rules for working in a controlled area.
  • Train other staff, researchers, or students in production or quality control processes as required.
  • Act as the point of contact between the PET production/quality control team and the clinical team when senior staff are unavailable.
  • 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 and automated synthesis platforms.
  • Engage with quality control staff training program and be competent to operate all quality control equipment in the laboratory.
  • Operate the PET Trace Cyclotron for production of radionuclides after appropriate training.
  • Raise Quality Exception Reports as required, including completing Root Cause Analyses.
  • Excellent time keeping, reliable, flexible, and able to work with a variety of people.
Requirements
  • Knowledge of PET radiotracer synthesis and quality control.
  • Practical experience with the production and/or quality control of PET radiopharmaceuticals.
  • 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.

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