Senior Radiochemist
2 weeks ago
We are seeking a highly skilled and experienced Senior Production/QC Radiochemist to join our team at the PET Centre, Kings College London. As a key member of our radiochemistry team, you will play a critical role in the production and quality control of PET radiopharmaceuticals.
Key Responsibilities- Develop and implement new tracers through practical validation work, ensuring compliance with GMP requirements.
- Support GMP compliance by performing practical validation work and updating SOPs as directed by senior radiochemists.
- Train and mentor other staff members in production and QC processes, ensuring a high level of expertise within the team.
- 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, with flexibility to adapt to changing service needs.
- Comply with local rules for working in a controlled area and follow strict aseptic techniques when working in the isolator hot-cell.
- Communicate technical problems with equipment or processes to other team members, cyclotron engineers, clinicians, and senior staff.
- Update and write SOPs, logs, and records, as well as investigational reports, to ensure accuracy and compliance.
- Schedule priorities to ensure tasks are completed as required, with flexibility to adapt to changing demands.
- Perform routine administrative tasks, such as ordering and recording 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 absence of senior staff, act as the point of contact between the PET production/QC team and the clinical team, as appropriate.
- Engage actively with staff training programs and be competent to perform at least three different GMP manufacturing processes on different synthesis platforms.
- Engage actively with production staff training and be competent to operate hot-cells, automated synthesis platforms, and dispensing platforms.
- Engage actively with QC staff training and be competent to operate all QC equipment in the laboratory, including automatic injection HPLC, MCA detector, GC, TLC, and PTS, for GMP radiotracer productions.
- After appropriate training, operate the PET Trace Cyclotron for production of radionuclides to be used in synthesis processes.
- Raise Quality Exception Reports as required, including Occurrences, Deviations, Change Controls, and investigate quality exceptions, completing Root Cause Analyses and drafting Quality Exception Reports for approval by QA.
Knowledge and Skills
- Knowledge of and proven record in adhering to the principles of GLP and 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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