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The Production Chemist is responsible for the manufacture of PET (Positron Emission Tomography) radiopharmaceuticals in compliance with current Good Manufacturing Practice (cGMP), radiation safety regulations, and health & safety requirements. The role ensures timely and compliant production of radiotracers to meet clinical and commercial demands, while maintaining site regulatory and quality standards.

Key Duties and Responsibilities:

Pharmaceutical Quality System Maintenance:

• Participate in the periodic review, revision, and drafting of Standard Operating Procedures (SOPs) and batch-related documentation.
• Support the preparation of the facility for internal and external audits, including MHRA inspections and customer audits.
• Maintain compliance with GMP and radiation safety requirements throughout all production activities.
• Ensure adherence to PETNET procedures, company quality standards, and applicable regulatory licences (Marketing Authorisations, Specials Licences).

Quality System Records Management:

• Ensure correct and timely documentation of all production activities in real time, in line with ALCOA+ principles and the site Quality Management System.
• Maintain equipment maintenance records, cleaning logs, and environmental monitoring data to ensure audit readiness.

Batch Documentation and Control:

• Ensure accurate and complete batch documentation is generated during manufacturing.
• Ensure packaging, labelling, and shipment records are maintained for all batches, including compliance with ADR regulations for radioactive materials.
• Monitor and maintain stock levels of materials and consumables, ensuring traceability and stock control documentation is current.

Production Operations:

• Perform manufacturing of PET radiopharmaceuticals in accordance with approved authorisations and SOPs.
• Operate automated synthesis units, hot cells, and isolators to produce sterile radiopharmaceutical products.
• Conduct pre- and post-production cleaning and sanitisation of the cleanroom, isolators, and associated equipment.
• Perform daily and routine maintenance of production equipment and environmental monitoring devices.
• Monitor and maintain materials stock levels, and initiate reorders where required.
• Label, store, and dispose of chemicals and radioactive materials in line with PETNET procedures and legislation.
• Operate the cyclotron particle accelerator safely and efficiently to support radionuclide production.
• Ensure accurate packaging, labelling, and shipment of radioactive materials in full compliance with ADR and internal procedures.
• Work according to the shift pattern, including early mornings and weekends, as required by operational demands.

Key Interfaces:

• Quality Assurance.
• Quality Control.
• Cyclotron Engineer.
• Radiation Protection Supervisor (RPS).

Qualifications and Experience:

Essential:

• Degree in Chemistry, Radiochemistry, Pharmacy, Chemical Engineering, or a related scientific discipline, or equivalent experience in a highly regulated environment.
• Experience working in a GMP-regulated environment (e.g. pharmaceutical, biotech, radiopharmaceutical manufacturing).
• Strong understanding of cleanroom operations and aseptic techniques.

Desirable:

• Previous experience in PET radiopharmaceutical production.
• Experience operating cyclotron or automated synthesis modules.
• Dangerous goods handling and ADR shipping training.
• Familiarity with MHRA expectations.
• Knowledge of radiation safety principles and safe handling of radioactive materials.

Core Competencies:

• Attention to detail and ability to follow SOPs precisely.
• Strong documentation and data integrity practices.
• Teamwork and collaboration.
• Proactive problem-solving.
• Flexibility to work shifts and respond to operational needs.
• High standards of cleanliness, safety, and compliance.

Benefits:

• 26 days' holiday with the option to buy or sell an additional 5
• Up to 10% employer pension contribution
• Share and bonus scheme
• Access to our flexible benefits from private medical insurance to dental cover
• Corporate Social Responsibility opportunities including 2 paid volunteering days per year and support from our 24/7 employee assistance programme.

Who we are:
We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:
When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Check our Careers Site at https://www.siemens-healthineers.com/en-uk/careers

As an equal opportunity employer, we welcome applications from individuals with disabilities.

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