Production Radiochemist

Alliance Medical; Dinnington; On-site; GBP 30,000 - 40,000; Full time

Job summary

Alliance Medical in Dinnington is offering a full-time position for a Production Radiochemist. The successful candidate will be responsible for daily routine production of PET radiopharmaceuticals, ensuring compliance with GMP standards and safety regulations.

The role entails shift work, including nights, and requires a scientific background, organization skills, and experience in pharmaceutical manufacture in a GMP environment. Training for backup production will also be a part of the role.

Qualifications

• Should be a scientific graduate with experience in (radio) pharmaceutical manufacture in a GMP environment.
• Ideally demonstrate knowledge of GMP, validation, and relevant regulations.
• Previous experience of operating in a GMP grade C cleanroom is advantageous.

Responsibilities

• Perform daily production of PET radiopharmaceuticals like 18F-FDG following GMP standards.
• Arrange maintenance for production equipment and undertake troubleshooting.
• Operate routine protocols for customer orders and distribution of radiopharmaceuticals.

Skills

Excellent verbal and written communication skills

Analytical skills

Logical approach to problem solving

Attention to detail

Organisational skills

Ability to work under pressure

Education

Degree in a related scientific discipline

Job description

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 Site open 24/6 with operational hours 00:00 to 20:00 so shift work is required.

You should be aScientific 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 liaising 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.