Radiopharmaceutical Scientist

Detailed job description and main responsibilities

Aseptic Preparation

Participate in all areas pertaining to the daily production of diagnostic and therapeutic radiopharmaceuticals with a high level of specialist skill, accuracy, and precision in accordance with GMP standards and departmental standard operating procedures.

Ensure all radiopharmaceutical products are of the required product quality and are fit for purpose through accurate and safe manufacture, and correct labelling and storage.

Carry out daily in-process checking and final productions checks of manufactured radiopharmaceuticals.

Act as a Releasing Officer in order to perform batch release (delegated) of radiopharmaceuticals for clinical use.

Ensure all radioactive consignments and their corresponding transport documents to external clinical centres are appropriately packaged and dispatched in a timely manner.

Accurately prepare and assemble radiopharmaceutical products and worksheets for production activities and ensure all records are correctly maintained for statutory and audit review purposes.

Communication

Liaise and deal with queries or complaints arising from external centres with regards to, for example, product order changes, product supply interruptions, or specialist technical product related issues.

Liaise and deal with transport couriers and various commercial suppliers with regards to, for example, transport issues or products/materials supply problems.

Perform radiolabelling of blood products with a high degree of skill, accuracy, concentration, and manual dexterity in order to ensure that they are fit for purpose.

Attend quality meetings & audits and participate in facility inspections by external personnel; assist in the implementation of any preventative and corrective actions to address deficiencies.

Provide dedicated support to the Production Manager in the investigation and root cause analysis of facility and quality deviations and assist in their accurate and timely documentation; assist in the implementation of any preventative and corrective actions.

Assist in the documentation and handling of complaints from internal and external stakeholders and recall of defective products.

Immediately report all equipment, facility, and environmental monitoring faults & deviations to the Production Manager, for example, faulty isolator particle counters, failed isolator leak tests, and refrigerator temperature excursions.

Liaise with Pharmacy Quality Assurance & Control (QA & C) colleagues in order to organise microbiological and facility monitoring regimens within the Radiopharmacy and act as dedicated person of contact between Radiopharmacy and Pharmacy QA & C.

Liaise and deal with external contractors in order to trouble-shoot and resolve queries, for example, arising from facility and equipment (including software) issues, as well as, organisation of validation schedules.

Liaise with Swansea Bay University Health Board Estates department to trouble-shoot any minor problems with the Radiopharmacy air handling unit or defects with the fabrics of the facility.

Quality Assurance & Control

In collaboration with the Production Manager, lead on the general day-to-day management and organisation of the Pharmaceutical Quality System, for example, by ensuring staff competencies & validation, authoring & issuing of controlled documents, validation documentation & schedules, capacity plan tools, and the deviations tracker are accurate and up-to-date.

Provide dedicated support to the Production Manager in the documentation, implementation, and management of change within the Radiopharmacy, for example, with the installation of new equipment and implementation of new processes and software.

Assist with specialist facility cleaning in cleanrooms and isolators, as well as, the safe and timely transfer of goods and materials throughout classified and unclassified areas.

Perform a range of routine and non-routine laboratory and radiopharmaceutical quality control & validation tests in accordance with defined protocols and report any deviations and out-of-specification results to the Production Manager.

Record all results accurately and keep appropriate records.

Stock Control & Distribution

Responsible for ensuring that the appropriate levels of critical stock such as ‘cold’ kits and raw materials is maintained at all times. Regular checking of stock, product expiry dates, and storage conditions; removal of surplus, expired stock and/or recalled products.

Report stock shortages and any stock discrepancies to the Production Manager and/or Chief Clinical Technologist in order to ensure that pharmaceutical products are available when required.

To assist with the timely ordering of finished radiopharmaceutical products (e.g. 123I ioflupane) in accordance with departmental needs and cross-referencing with the various radionuclide specific holdings permitted by Natural Resources Wales (NRW).

Order, receive, check, and reconcile materials whenever necessary. Accurately enter details into the appropriate stock inventory and ensure transfer of materials to the correct storage location.

 Health and Safety

Undertake maintenance of safe systems of work within the Radiopharmacy; undertake all work in accordance with local rules and national regulations including the Health and Safety at Work Act 1974, the Ionising Radiation Regulations 2017, the Ionising Radiation (Medical Exposure) (Amendment) Regulations 2018, Environmental Permitting (England and Wales) Regulations 2016, the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations (Amendment) (EU Exit) 2020 and the Control of Substances Hazardous to Health Regulations 2002.

Handle, store, and dispose of radiopharmaceutical waste in a safe and timely manner with due regards to local radioactive waste disposal procedures and environmental regulations.

Maintain a standard of personal hygiene required for working within an aseptic manufacturing facility.

Lead on the generation of Radiopharmacy reports and risk assessments, for example, trending of deviation data, unit manufacturing output, and validation processes.

Responsible for the maintenance, storage, and disposal of chemicals as they pertain to Control of Substances Hazardous to Health Regulations (COSHH) 2002.

Management, Teaching, Training, and Research & Development

Line management of Radiopharmaceutical Technical Officers and/or Clinical Technologists (if required); including personal development & appraisal, performance management, and management of attendance at work. Contributing to recruitment and selection.

Participate in the general teaching and training of staff members, undergraduate and postgraduate students, and others as required on radiopharmacy equipment use, including instrumentation, aseptic preparation, and quality control of radiopharmaceuticals .

Carry out daily, weekly, and monthly testing of specialist Radiopharmacy equipment and facilities, reporting and trend analysis of results, and assist in the trouble-shooting of faults found.

Participate in research protocols and new product validations; assist in setting up clinical trials.

Organising undergraduate and postgraduate student placements (for example, BSc, MPharm, & PharmD).

Supervise students and trainees and monitor performance in respect of their attendance and work (for example, research projects).

Undertake initial and ongoing training and re-validation in all relevant aspects of the Radiopharmacy service.

Contribute to own personal development plans by attending appropriate training courses and participate actively in Continuing Professional Development (CPD) and regular assessment of personal quality standards.

Keep abreast of technical and scientific developments and their applications in Radiopharmacy by attending suitable webinars, seminars, courses, and national and international meetings.

The post holder must be professionally registered and abide by their professional code of conduct.

Act as a professional and technical role model within the department. Be responsible for maintaining their own professional registration and revalidation schedule.

Planning & Organisation

In collaboration with other senior team members, contribute to the planning and general organisation of workload and duties in the Radiopharmacy. Delegate tasks appropriately and work within a pre-planned Radiopharmacy rota but be responsive and flexible to changes in order to meet the needs of the service.

Willingness to travel on occasion to external clinical centres in order to perform professional duties.

This job description is not intended to be exhaustive, and it is likely that duties may be altered on occasion in light of changing circumstances and after consultation with the post holder.

Assist with the coordination and facilitation of internal and external contractors visiting the facility to perform, for example, environmental monitoring, repairs, and/or maintenance and ensure a safe handover. Communicate and/or escalate issues to the Production Manager as appropriate.

 Annex 21

If candidates do not have the required professional registration, training, and/or experience to meet the full competency framework of this permanent Band 7 post, then they will be employed under Annex 21 rules and must commit to undertaking a supportive two-year development plan.

Annex 21 Band 7 pay = 70% of top rate of Band 7 for Year 1; and, 75% for Year 2.

Following successful completion and successful attainment of the necessary qualifications, skills, and competencies, the post-holder will then be paid at the full Band 7 (at the minimum point on the scale and following the usual pay steps).