We are looking to engage a science graduate with the appropriate skills, qualifications and scientific background, to undertake GMP clean-room manufacture of our PET tracer products at our site in Sutton.RADIOCHEMIST (PRODUCTION)
Undertake production of Fluorine-18 (18F) and radio-synthesis of 18F radiopharmaceuticals for PET imaging.YOUR PLACE IN OUR WORLD Operations Manager
Production Radiochemist SKILLS REQUIRED IT SKILLS DUTIES & RESPONSIBILITIES
Operate and maintain protocols for the manufacture of 18F and for the Alliance Medical Radiopharmacy chemistry laboratory including the production synthesis of standard 18FDG, 18Ethylcholine (18FEC), and other PET tracers in strict adherence to GMP and relevant EU pharmacopoeia standards.
Operate routine protocols for customer orders and distribution of 18FDG and other PET tracers to sites.
Arrange first-line scheduled and emergency maintenance for the cyclotron and associated plant, in collaboration with GE engineers. Participate in GE training courses and maintain links with the GE Medical Systems, Sweden and other ‘PETtrace’ centres.
Ensure efficient performance of, and undertake first-line maintenance of, the FDG & FEC Synthesisers, Dispensing Equipment, Hot Cells, including dose calibration, monitoring and sterility checks within the contet 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 indicate where the GE engineer or contractor should be called.
Develop, implement and manage cGMP, Quality Control and Quality Assurance systems and procedures for all aspects of cyclotron operations, and radiopharmaceutical production of standard PET tracers
On a rota basis, act as either cyclotron principal operator or as principal laboratory technician for radio-synthesis of PET tracers in accordance with a pre-determined daily timetable.
Maintain routine protocols for production of standard 18F and other PET targetary in accordance with GMP guidelines.
Maintenance and Engineering Services
Support appropriate Maintenance/Engineering arrangements to ensure reliable delivery of critical services including air handling, chilled water, gases, electric power and security.
Ordering of stock, preparation of chemicals required for routine radiochemistry production including formulation of reagents, etc and the safe disposal of waste chemicals and materials.
Standard Operating Procedures
Prepare updated SOPs in accordance with the relevant guidelines as may be necessary from time to time for approval by the QP and adoption by the unit.
Provide training and support for others selected as rota/backup in cyclotron operation and production of Radiopharmaceuticals.
R & D
Search out, promote and manage R&D initiatives that both enhance the reputation of Alliance Medical Radiopharmacy and their professional staffs as is consistent within approved budgets and grants.
Skills in Radiochemistry
Develop necessary skills to provide relief and rota support to radiochemical laboratory technician/s with specific reference to the functions of:
- Operation of cyclotron.
- Production of Radioisotopes
Safety and Control
- 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