Senior Pharmaceutical Scientist

Cardiff University; United Kingdom; On-site; GBP 40,000 - 46,000; Full time

Job summary

An established industry player is seeking a Senior Radiopharmaceutical Scientist to join their innovative team at a state-of-the-art facility. This role offers a unique opportunity to lead GMP production and contribute to the development of radiopharmaceuticals. You will utilize your technical expertise to ensure compliance with GMP standards while managing complex projects and training staff. With excellent benefits and a supportive working environment, this position is perfect for those looking to make a significant impact in the field of radiopharmacy.

Benefits

45 days annual leave

Pension scheme

Cycle-to-work scheme

Annual pay scale increments

Qualifications

• Significant experience in GMP aseptic pharmaceutical facilities.
• Knowledge of radiochemistry and automated process equipment.

Responsibilities

• Lead investigations into GMP production issues and manage production facilities.
• Perform maintenance and troubleshooting of critical GMP equipment.

Skills

GMP Aseptic Techniques

Radiochemistry

Problem Solving

Communication Skills

Project Management

Education

Degree/NVQ 4 in a relevant scientific discipline

Tools

Cyclotron

Automated Process Equipment

Job description

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, troubleshooting, and repair of our critical equipment and the associated utilities infrastructure. You will perform equipment and process validation for F-18 radiopharmaceutical production and dispensing, including preparing and executing protocols, and providing professional advice and guidance to the team.

This position offers an excellent platform to utilize your technical expertise and regulatory knowledge to plan and deliver small-scale projects, identify resolutions for complex issues, and minimize downtime of the cleanroom facilities.

You will work closely with the Head of Radiopharmacy Production and will be involved in staff training and development, 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 the active rota of production, dispensing, and quality control of radiopharmaceuticals, operating a range of automated and manual radiochemical synthesis. Accurate weighing and measuring of materials for pharmaceutical preparations will be required, along with some moderate lifting up to 15kg.

If you would like to learn more about this position, please contact Syed Bukhari at 02920 742005 or via email at [e-mail].

This full-time (35 hours/week), fixed-term role for 3 years is available immediately, based at Heath Park, Cardiff. It may also be offered as a secondment opportunity.

Salary: £40,497 - £45,413 per annum (Grade 6). Cardiff University typically appoints at the bottom of the scale unless in exceptional circumstances.

Working hours may start between 07:00 and 09:00, with occasional early starts as early as 4:00 am, and occasional Saturday work on a rota basis.

Cardiff University offers excellent benefits, including 45 days annual leave, pension scheme, cycle-to-work scheme, annual pay scale increments, and more. It is a vibrant place to work with diverse 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 only to Cardiff University employees. External applications are now invited.

Applications may be submitted in Welsh, and submissions in Welsh will not be treated less favorably than those in English.

Cardiff University is committed to equality and diversity and supports an inclusive working environment. We welcome applicants from all backgrounds regardless of sex, ethnicity, disability, sexual orientation, trans identity, relationship status, religion or belief, caring responsibilities, or age. Flexible working or job share proposals will also be considered.

Job Description

Key Duties

1. Act as the technical lead to assist the Head of Radiopharmacy Production with managing GMP production facilities, leading investigations into issues with PETIC's F-18 tracer production.
2. Plan and deliver small-scale projects to improve process capability and security of F-18 radiopharmaceutical provision, coordinating project teams as needed.
3. Use expert knowledge to risk assess problems with GMP radiopharmaceutical processes, suggesting appropriate solutions to minimize downtime.
4. Perform first-line maintenance, troubleshooting, and repair of critical GMP equipment, including F-18 synthesis and dispensing equipment, hot cells, and utilities infrastructure.
5. Lead complex investigations into GMP production issues, providing technical input and analysis.
6. Lead equipment and process validation for F-18 radiopharmaceutical production, including protocol preparation and execution.
7. Develop communication links with internal and external stakeholders, including Cardiff University and NHS Trusts.
8. Support training and development of GMP production staff, ensuring procedures are implemented and staff are compliant with GMP and radiation safety regulations.
9. Ensure GMP-compliant production, storage, and transport of PET radiopharmaceuticals, with accurate documentation.
10. Proactively review and improve SOPs, work instructions, and policies to ensure compliance with GMP, QA, transport, waste management, and radiation safety standards.
11. Assist in maintenance of the PETIC PQS, participating in deviation, CAPA, and change control management.
12. Manage PETIC's asset register, ensuring equipment is validated, calibrated, and maintained.
13. Participate in GMP cleanroom operations, including environmental monitoring and handling incoming materials.
14. Perform administrative duties to support the department.
15. Lead and motivate PETIC staff to approach challenges positively.
16. Perform dangerous goods shipments following PETIC procedures and ADR regulations.
17. Maintain professional development in GMP PET radiopharmaceuticals and aseptic manufacturing.
18. Manufacture radiopharmaceuticals in compliance with MS license, GMP standards, and PETIC PQS.
19. Perform cleaning and maintenance of cleanrooms and equipment.

Additional Information

***Continued responsibilities include***

• Preparing for audits and inspections.
• Maintaining stock levels and cleanliness of storage areas.
• Operating the cyclotron particle accelerator.

General Duties

• Deputize for the Head of Radiopharmacy Production as needed.
• Maintain confidentiality and adhere to university policies on Health and Safety and Diversity.
• Perform other duties consistent with the role.
• Act as Radiation Protection Supervisor, ensuring radiation safety and compliance with local rules and regulations.
• Participate in GMP production operations, including weekends and out-of-hours work as required.

This role involves manual handling of radioactive sources, requiring excellent manual dexterity, the ability to work in radiation-controlled areas, moderate lifting, and working under pressure.

Person Specification

Essential Criteria

1. Degree/NVQ 4 or equivalent in a relevant scientific discipline.

Knowledge, Skills, and Experience

1. Significant experience in GMP aseptic pharmaceutical or radiochemistry facilities, operating automated and remote process equipment, troubleshooting.
2. Experience developing processes and procedures, including practical laboratory skills.

Customer Service, Communication, and Teamwork

1. Good report writing and verbal communication skills, capable of conveying complex information professionally.
2. Ability to explore customer needs and adapt services accordingly.
3. Meticulous attention to detail.

Planning, Analysis, and Problem Solving

1. Ability to solve complex problems using initiative and creativity; propose practical and innovative solutions.
2. Work independently to deadlines, plan, and prioritize tasks.
3. Ability to deliver projects and supervise short-term teams.

Desirable Criteria

1. Postgraduate or professional qualification.
2. Experience in F-18 PET Radiopharmacy.
3. Knowledge of isolator and cleanroom technology.
4. High-level mechanical, electrical, or control systems knowledge.
5. Fluent in Welsh, written and spoken.