Production Manager in Guildford

We have a new opportunity for a Production Manager to join our Guildford Radiopharmacy team. This is a full time position working 40 hours a week. Our site's operational hours are 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. To be successful in this role you will demonstrate 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. Be educated to a degree level in a related scientific discipline or able to demonstrate relevant experience. Ideally, be able to demonstrate experience in Radiochemistry or related disciplines. Ideally, be able to demonstrate 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 be advantageous.

Production

• 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.

Maintenance

• 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 Synthesisers, Dispensing Equipment, Hot Cells, including dose calibration, monitoring and sterility checks within the context of strict application of environmental and ‘clean room’ protocols.

Faults

• 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.

Quality Systems

• Operating 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.

Principal Operator/Timetable

• 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.

Chemical Preparation

• Monitoring and maintaining lab stocks of chemicals, consumables, and spare parts as well as the safe disposal of waste chemicals and materials.

Standard Operating Procedures

• Prepare and review SOPs in accordance with the relevant guidelines for approval by the QP and adoption by the unit.

Training Others

• Provide training and support for others selected as rota/backup in production of Radiopharmaceuticals.

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.

Regulatory

• 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.

Alliance Medical are Europe’s leading independent provider of imaging services. We combine service excellence and innovative imaging technologies to improve patient care and support NHS and independent organisations with their ongoing imaging requirements. Our approach has delivered consistent company growth for more than 30 years. We live by our company values to ensure the highest level of patient care:

• Collaboration: We work together and in partnership for all our patients. We respect expertise and combine it to achieve more.
• Excellence: We never compromise. We strive to deliver the very best in everything we do to ensure the highest quality of care. We treat our patients and each other with compassion, dignity and respect.
• Learning: Knowledge and understanding comes from learning. At Alliance Medical we are committed to ensuring that each and every one of us keeps on learning and that we continuously look for improved ways of working.
• Efficiency: Efficiency in healthcare means more patients get better care. We constantly seek new ways to use the scarce resource of healthcare more intelligently so that more people can live longer, fuller lives.
• Openness: We act with transparency and honesty in everything we do, where staff are encouraged to speak up to ensure a safe and secure environment for our patients.