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.
The post holder will be involved from the early stages of the project which will involve drafting documentation including SOPs and validation protocols for review. Executing validation protocols for the production and quality control of radiopharmaceutical products.
Upon completion of the project the post holder will participate in the GMP production, sterile and aseptic dispensing, and quality control of PET radiotracers for clinical use. Operating a range of automated and manual radiochemical synthesis and quality control equipment. 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.
Project Phase
- Contributing technical knowledge and participating in the preparation and review of documentation for the build, installation, and commissioning of the PET Radiopharmacy
- Assisting with the validation of equipment, production and QC processes according to approved protocols
- Drafting and maintaining COSH and radiation risk assessments
Prepare PET Radiopharmaceuticals
- Manufacture PET radiopharmaceuticals using hot cell and isolators
- Sanitisation/cleaning aseptic suite facilities
- Aseptic dispensing of PET radiopharmaceuticals using negative pressure isolator technology
- Adopting radiation protection technique at all times ALARA
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
Participation in maintaining clean room
- 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, Radiations monitoring
- First line maintenance of equipment
Quality Control and Quality Assurance Compliance
- 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
- 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
- Assist in qualification/requalification exercise as required including preparing documentation and execution of protocols
- Setting up production orders in the system
- Checking stock level and ordering products
- 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
- Working knowledge of pharmaceutical chemistry and good manufacturing practice is required
- 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.
- Validation experience (Desirable)
Education/experience
- Related Science Degree
- Aseptic dispensing or Radiopharmacy experience desirable
Skills
- Excellent team player but also 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
Communicating Effectively
Relevant Work Experience
Making Accurate Judgments and Decisions
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.
