Production Radiochemist

We have a new opportunity for a Production Radiochemist to join our Radiopharmacy team. This is a full time position working 40 hours a week. Our site's operational hours are 24/6 with operational hours from 00:00 to 20:00, so shift work is required.

You should be a scientific graduate with a scientific background, ideally with experience of (radio) pharmaceutical manufacture in a GMP environment. Qualifications include excellent verbal and written communication skills, analytical skills, a logical approach to problem solving, and good attention to detail. As an effective team member, you will have great organisational skills with the ability to work under pressure. You should be educated to a degree level in a related scientific discipline or able to demonstrate relevant experience. Ideally, you should be able to demonstrate experience in Radiochemistry or related disciplines, as well as knowledge of GMP, validation, and relevant regulations. Validation experience (including laboratory equipment and process validation) would be advantageous. Previous experience of operating in a GMP grade C cleanroom, operation of a GMP grade A isolator, and/or distribution of radiopharmaceuticals would also be advantageous.

Responsibilities:

• Daily, routine production of PET radiopharmaceuticals, including 18F-FDG, for Alliance Medical Radiopharmacy in strict adherence to GMP and relevant EU pharmacopoeia standards.
• Operate routine protocols for customer orders and distribution of 18FDG and other PET and tracers to scanning sites.
• Arrange first-line scheduled and emergency maintenance for production equipment and associated plant, in collaboration with Alliance Medical Radiopharmacy engineers.
• Ensure efficient performance of, and undertake first-line maintenance and any required troubleshooting of the FDG Synthesizers, Dispensing Equipment, Hot Cells, including dose calibration, monitoring, and sterility checks within the context of strict application of environmental and ‘clean room’ protocols.
• Maintain records of faults on any dysfunction – operational, equipment or environment integrity.
• Interpret and rectify operational faults where possible and liaise with engineers and suppliers as necessary.
• Operate to approved quality standards by recording production quality related actions (e.g., deviations and change controls) in a timely manner, to comply with AMR policies and regulatory requirements.
• On a rota basis, act as production radiochemist for radio-synthesis of PET tracers in accordance with a pre-determined daily timetable. The role will include some night work on a rotational shift rota.
• Monitor and maintain lab stocks of chemicals, consumables, and spare parts as well as the safe disposal of waste chemicals and materials.
• Prepare and review SOPs in accordance with the relevant guidelines for approval by the QP and adoption by the unit.
• Provide training and support for others selected as rota/backup in production of Radiopharmaceuticals.
• Assume responsibility for the safe and efficient handling of all radioactive substances (solid, gas, liquid) received from the Centre’s cyclotron including their synthesis, transmission, dispensing, storage, containerisation, packing, despatch, transport, decay control, and release.
• In accordance with local rules for emergency or serious incident procedure, record such events in accordance with SOPs.
• Responsible for following agreed safety procedures to ensure safety of yourself and others.
• Strictly adhere to GMP, GLP and safety protocols laid down by the MHRA, EA and HSE in accordance with issued licenses as determined from time to time.
• Corresponding adherence to local rules developed by Alliance Medical Radiopharmacy in conformity to such licensing requirement.