19850BR
School of Medicine
Managerial, Professional and Specialist Staff – MPSS
Advert
Senior Radiopharmaceutical Scientist
Wales Positron Emission Tomography Imaging Centre (PETIC)
Clinical Innovation Hub - School of Medicine
The Wales Research and Diagnostic PET Imaging Facility is a state-of-the-art PET centre, fully equipped with a cyclotron and GMP and R&D radiochemistry facilities to produce both established and new GMP grade PET radiotracers for clinical use.
We have a rare and exciting opportunity for an enthusiastic, highly motivated and technically-minded individual with an ambition to take a lead role in our team of experts, who produce radiopharmaceuticals to Good Manufacturing Practices (GMP) standards in a purpose designed GMP manufacturing facility.
In this role you will be a key member of PETIC’s GMP Production Team and will be responsible for providing first line technical support for the maintenance, trouble shooting and repair of our critical equipment and the associated utilities infrastructure. You will be the key person to perform equipment and process validation for F-18 radiopharmaceutical production and dispensing, including preparation and execution of protocols and providing professional advice and guidance to the team.
This role will provide you with the ideal platform to utilise your technical expertise and regulatory knowledge, to plan and deliver on small scale projects to identity the perfect resolution for complex issues, whilst minimising the downtime of the cleanroom facilities.
You will work closely with the Head of Radiopharmacy Production and will be involved be involved in a wide range of tasks, including staff training and development, assisting in all aspects of operating and maintaining the facility to GMP standards, including equipment and laboratory maintenance and validation, environmental monitoring, incoming materials management and stock control.
You will also participate in an active rota of production, dispensing and quality control of radiopharmaceuticals, operating a range of automated and manual radiochemical synthesis. You will be expected to accurately weigh and measure materials for pharmaceutical preparations and there will be some moderate lifting up to 15kg unaided.
If you would like to know more about this position, then please contact Syed Bukhari on 02920 742005 or via email at BukhariS4@cardiff.ac.uk.
This post is full time (35 hours per week), fixed term for 3 years and is available immediately. The post will be based at Heath Park, Cardiff and can also be offered as a secondment opportunity.
Salary: £40,497 - £45,413 per annum (Grade 6) Appointments to roles at Cardiff University are usually made at bottom of scale unless in exceptional circumstances.
Please be aware that the typical working day will begin between 07:00am- 09.00am, which will be dependent upon the GMP production rota. However, there may also be a rare occasion to work flexibly with a possible start time as early as 4.00am. There will be occasional Saturday work on a rota basis, based on business need.
Cardiff University offers many excellent benefits, including 45 days annual leave (incl. bank holidays), local pension scheme, a cycle to work scheme and other travel initiatives, annual increments within the pay scale, and more. It's an exciting and vibrant place to work with many different challenges and is a proud Living Wage supporter.
Date advert posted: Tuesday, 29 April 2025
Closing date: Tuesday, 20 May 2025
This post has previously been advertised to employees of Cardiff University only. We now invite external applications.
Applications may be submitted in Welsh, and an application submitted in Welsh will not be treated less favourably than an application submitted in English.
Cardiff University is committed to supporting and promoting equality and diversity and to creating an inclusive working environment. We believe this can be achieved through attracting, developing, and retaining a diverse range of staff from many different backgrounds. We therefore welcome applicants from all sections of the community regardless of sex, ethnicity, disability, sexual orientation, trans identity, relationship status, religion or belief, caring responsibilities, or age. In supporting our employees to achieve a balance between their work and their personal lives, we will also consider proposals for flexible working or job share arrangements.
Job Description
Key Duties
* Act as the technical lead to assist the Head of Radiopharmacy Production with the management of the GMP production facilities: Lead investigations into, and analyse specific issues with, PETIC’s radiopharmaceutical F-18 tracer production facility.
* Plan and deliver specific small-scale projects related to improving process capability and security of provision of F-18 radiopharmaceutical products, co-ordinating and supervising project teams created as needed.
* Use expert technical and regulatory knowledge to risk assess problems with the GMP radiopharmaceutical production processes, suggesting the most appropriate course of action to resolve complex issues with minimum downtime of the cleanroom facilities.
* Take responsibility for executing first-line maintenance, troubleshooting and repair of critical GMP facility equipment (including F-18 synthesis and dispensing equipment and hot cells; and the associated utilities infrastructure).
* Provide expert knowledge and technical input to lead complex investigations into, and analyse specific issues with, the GMP radiopharmaceutical production facility.
* Provide professional advice and guidance to lead and perform equipment and process validation for F-18 radiopharmaceutical production and dispensing, including preparation and execution of protocols.
* Develop appropriate communication links and establish working relationships with internal and external customers, departments and contractors, including Cardiff University and the Cardiff and Vale NHS Trusts Estates teams.
* Proactively assist and support the Head of Radiopharmacy Production in the training and development of PETIC’s GMP production staff: ensuring that revised procedures are effectively implemented and practically trained out, and all staff comply with internal procedures, Good Manufacturing Practice and the Ionising Radiation Regulations.
* GMP compliant day-to-day production of PET radiopharmaceuticals, ensuring products are manufactured, stored and transported appropriately to ensure they are fit for clinical use, and documentation is completed fully and accurately.
* Proactively author, review and continuously improve Standard Operating Procedures, work instructions and policies to ensure compliance within current standards of GMP, Quality Assurance, transport, waste management and radiation safety.
* Assist in the maintenance of the PETIC PQS, participating in deviation, CAPA and change control management, investigating and resolving issues within the required timeframe.
* Assist in the management of PETIC’s asset register ensuring all equipment is introduced, validated, calibrated, and maintained in accordance with defined schedules and processes.
* Assist with scheduling and participate in all tasks related to the running of the GMP cleanroom, including environmental monitoring.
* Handle, document and test incoming materials and consumables to ensure reagents and consumable stocks are available as needed.
* Undertake a variety of administrative duties to support the department.
* Instruct, guide and motivate other employees with PETIC, leading the team to approach challenges with positivity and determination.
* Perform the shipment of dangerous goods following PETIC inhouse procedures while ensuring the compliance with ADR regulations.
* Take responsibility for their own continuous professional development to achieve full awareness and technical knowledge of all current legislation and scientific development associated with GMP PET radiopharmaceuticals and aseptic manufacturing.
* Manufacture radiopharmaceuticals in compliance with the MS licence, ensuring production activities adhere to the PETIC Pharmaceutical Quality System and GMP standards.
* Perform cleaning and maintenance of clean rooms and associated equipment.
Person Specification
Essential Criteria
Qualifications and Education
* Degree/NVQ 4 or equivalent professional membership/experience in a relevant scientific discipline
Knowledge, Skills and Experience
* Substantial experience of working within a GMP aseptic pharmaceutical production facility and/or experience working within a radiochemistry facility and experience of operating automated and remotely operated process equipment and troubleshooting.
* Experience in developing new processes and procedures, including the associated practical laboratory skills.
Customer Service, Communication and Team Working
* Evidence of good report writing, verbal communication skills and the ability to communicate conceptually detailed and complex information effectively and professionally with a wide range of people
* Evidence of ability to explore customers’ needs and adapt the service accordingly to ensure a quality service is delivered.
* Meticulous attention to detail
Planning, Analysis and Problem solving
* Evidence of ability to solve expansive problems using initiative and creativity; identify and propose both practical and innovative solutions
* Evidence of ability to work unsupervised to deadline, planning and setting priorities for own work
* Evidence of ability to undertake and deliver specific projects and supervise short term project teams
Desirable Criteria
* Postgraduate/Professional qualification
* Previous experience in F-18 PET Radiopharmacy.
* Knowledge of isolator and cleanroom technology.
* High level knowledge and experience with mechanical, electrical and/or control systems
* Fluency in Welsh, written and oral
Additional Information
***Job description continued***
* Assist in the preparation of the facility for internal/external audits and regulatory inspections.
* Maintain adequate stock levels of consumables and spare parts, ensuring storage areas are kept clean and tidy.
* Operate the cyclotron particle accelerator
General Duties
* To deputise for the Head of Radiopharmacy Production when required.
* Ensure that an understanding of the importance of confidentiality is applied when undertaking all duties
* Abide by University policies on Health and Safety and Equality and Diversity
* Perform other duties occasionally which are not included above, but which will be consistent with the role
* Act as Radiation Protection Supervisor and maintain a surveillance of all aspects related to radiation safety of staff working in the Cyclotron Production Facility and advise all staff on safe working practices. Ensure all staff comply with the requirements of the Radiation Local Rules and Health and Safety at Work Order.
* Participate in the day-to-day operation of the GMP Production Facility, including weekends and out of hours where required.
The role within PETIC involves the manual handling of ionising sources of radiation (specially positron-emitting radionuclides). Cardiff University has a responsibility to follow legislation from Public Health Wales to minimise the radiation dose to workers and the public, amongst other requirements. We must also work within our permit conditions stipulated by Natural Resources Wales for the control of radioactive material.
Requirements
As a consequence, lead shielding is commonly employed in PETIC as a means to meet our legal requirements for the above-mentioned agencies. Workers in PETIC are required to handle and move containers made of lead, containing within them samples of radioactivity. Workers must be able to do this in a safe and controlled fashion to minimise radiation dose and/or lose of radioactive material. Where possible steps have been taken to minimise manual handling, however it is not reasonably practical to remove all handling of shielded containers within the facility. As a result, the role requires the following additional requirements:
* Excellent manual dexterity skills as will be working in fine details with their hands
* Able to use remote manipulators and tongs.
* Able to work continuously in a radiation-controlled area and manipulate heavy items/shielding associated with this.
* Have excellent hand to eye co ordination
* Moderate lifting (up to 15kg unaided)
* Standing for long periods in a restrictive position
* Able to work under pressure
Salary Range Min.
£40,497
Salary Range Max.
£45,413
Job Category
Technical
Grade
Grade 6 #J-18808-Ljbffr