Senior Radiopharmacy Technician Oxford

About Curium

Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

Summary of Position

The post holder will participate in the Cyclotron operation to generate 18F-Fluoride, GMP production, sterile and aseptic dispensing of PET Radiopharmaceutical tracers. Operating a range of automated and semi-automated radiochemical synthesis, sterile and aseptic dispensing equipment in hot cell isolator technology. The role also involves assisting in all aspects of operating and maintain the facility to GMP standards, including documentation, equipment and laboratory maintenance including cleaning, environmental monitoring, incoming materials management, and stock control. The post holder will operate within a regulated environment and work within a Quality Management System including but not limited to SOP revision, deviation and investigation reporting, execution of CAPAs and implementation of approved change control actions.

Essential Functions

- Cyclotron preparation, start up, irradiation and shutdown. Trending and reporting;

- Manufacture PET radiopharmaceuticals using isolator hot cell technology and automated synthesis units;

- Sanitisation/cleaning aseptic suite facilities;

- Dispensing of PET radiopharmaceuticals using negative pressure isolator technology and automated dispenser units (Aseptic and Sterile);

- Packing and dispatch of radiopharmaceuticals according to local guidelines and transport regulations;

- Collating received orders and inputting them into the dispensing database;

- To carry out staff training and knowledge sharing when applicable;

- Adopting radiation protection technique at all times ALARA;

- Sanitation and transferring of consumables in the aseptic suite and isolators;

- Cleaning the isolators and Radiopharmacy facility according to SOP’s;

- Aseptic Suite monitoring including Environmental monitoring and Radiation monitoring;

- First line maintenance of equipment;

- Stock control, inspection and release of incoming materials;

- Participate in radioactive and non-radioactive waste management activities;

- Gowning and hand washing qualification;

- Aseptic Process Qualification;

- Bioburden Testing;

- Perform routine environmental monitoring activities according to local procedures and schedule;

- Record and review results;

- Report excursions, and assist with investigations and corrective actions;

- Checking received orders;

- Production planning activities;

- Raising and completing deviation reports where applicable;

- Participate in Root Cause Analysis and CAPA identification;

- Effective communication with all colleagues to facilitate efficiency in both production and quality related matters;

- Maintain paper and electronic records from all production processes for statutory purposes, including production and quality control under GMP;

- Participate in qualification/requalification exercise as required including preparing documentation and execution of protocols;

- Participate in the self-inspection rota;

- Carry out Quality Control procedures analysing the radionuclide and radiochemical purity of radiopharmaceuticals using standard analysis packages as specified in the European Pharmacopoeia;

- Undertake laboratory cleaning, maintenance and procedures required for GMP analysis of radiopharmaceuticals;

- Examples of duties include: preparation of chemicals including HPLC solvents for routine use; monitoring and upkeep of PET radiochemistry modules and environment; assisting with the routine monitoring of facility and equipment, supervising routine servicing of equipment, testing and maintenance of user serviceable parts; receipting goods, checking materials and performing the stock control of laboratory consumables, chemicals and gases and disposal of waste chemicals and materials;

- Recording of the logs for fridge, freezers, isolator checks and all other logs;

- Adherence to legal and organizational procedures & guidelines about quality, safety, health and environmental issues;

- Comply with the requirements of the Pharmaceutical Good Manufacturing Practice (GMP), Ionising Radiation Local Rules, COSSH and Health & Safety procedure;

- Training of Technicians in PET manufacturing and QC processes, and standard operating procedures across the site;

- Maintain inspection readiness through GMP-compliant documentation and practices;

- Support site regulatory inspections and audits;

- Assist with the completion of follow-up actions.

Requirements

Valid independant work permit

- Knowledge of Ionising Radiation Local Rules, COSSH and Health & Safety procedure (Desirable);

- Knowledge of working within a GMP environment;

- Willingness to work flexibly on a rotating 12 hour shift pattern between 00:00 (midnight) to 17:00 after the site initiation project is complete;

- Validation experience (Desirable);

- Related Science Degree;

- Aseptic dispensing experience or Radiopharmacy experience;

- 3-5 years professional experience;

- Working knowledge of pharmaceutical chemistry and good manufacturing practice is required.

Skills:

- Excellent team player;

- Be able to work on own initiative;

- Good customer relation skills;

- Communication skills;

- Practical ability;

- Excellent timekeeping competences;

- Stress handling;

- Excellent attention to detail;

- High level of computer literacy.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Disability Confident Employer

We are proud to be a Disability Confident Level 1 employer and are committed to fostering an inclusive workplace where everyone can thrive. We welcome applications from candidates of all backgrounds, including people with disabilities.