Radiochemist

Position Overview

Under the general supervision of the Director, Winnipeg Cyclotron Facility and Central Radiopharmacy, the incumbent is responsible for:

1. Supporting  the technical operations of the at the Winnipeg Cyclotron Facility and Radiopharmacy, including preparation of Radiopharmaceuticals for both clinical and research use. This includes the whole cycle from cyclotron production of radioisotopes, to radiopharmaceutical manufacturing to quality control testing.
2. Assisting with the day-to-day schedulingof the cyclotron program technical staff for production and QC activities, and providing guidance as needed. 
3. Provide technical expertise in matters related to the production and quality control testing of radiopharmaceuticals, including supporing Quality Program investigations of nonconformances in the manufacture and testing of Radiopharmaceuticals, and informing the Director of any issues related to production, testing or related activities .
4. Assisting with implementation of production and quality control testing of new products for clinical and research use in collaboration with the Quality Program.
5. Supporting the maintenance of training program for cyclotron facility technical staff and remaining qualified to perform all core technical  and maintenance activities.
6. Reviews trends in PERs production results and works with Director and Quality Program to implement process improvements to correct negative trends.
7. Reports to the Director on the status of the Winnipeg Cyclotron Facility operations and identifies alternatives and strategies for the delivery of PERs manufacturing and quality control testing practices.
8. Working with the Director and the Quality Program to keep Standard Operation Procedures (SOPs) current for program activities.
9. Working with the Director and Quality Program to ensure that product manufacturing and quality control testing is consistent with product monograph, reference product or master drug files.
10. Keeps up-to-date on current CNSC and Health Canada regulations related to radiopharmaceuticals and responds to proposed changes as may be appropriate according to the likely impact on program operation.
11. Maintains current competence in all facets of PERs manufacturing procedures in order to carry out manufacturing or product quality control testing if required and to adequately train technical staff.
12. Supports the technical aspects of equipment selection, installation and qualification for the cyclotron program.
13. Collects, processes and reports on samples for viable and non-viable particle monitoring as part of the environmental monitoring (EM) program.
14. Step in to perform technical duties as needed during short staffing situations.
15. Performs all routine technical activities such as EM, cleaning, other duties as sassigned to ensure continuity of production and quality control.
16. Operates the cyclotron as auxiliary cyclotron operator, including off hours such as evenings and weekends as may be required to meet customer radiopharmaceutical requirements.
17. Contributes to PERs related research and development activity through both internal and interdepartmental projects.
18. Other duties as assigned.

Experience

• A minimum of 3 years experience in a clinical or research positron emission radiopharmaceuticals (PERs) laboratory.
• At least two years of experience in a Good Manufacturing Practices (GMP) environment.
• Advanced knowledge of the production and quality control of PERs in a GMP environment.
• Two or more years of experience with quality control (QC), GC, TLC and HPLC.
• Experience in programming and running of automated synthesis units (ASUs) for both [11C] and [18F] radiosynthesis.
• Experience working in a cyclotron or radiopharmacy program would be an asset.
• Experience with the Canadian regulatory framework, including both Health Canada and the Canadian Nuclear Safety Commission (CNSC) would be an asset.
• Experience with supervision of technical staff and/or trainees would be an asset.
• Experience in microbiology testing as applicable to PERs manufacturing would be an asset.

Education (Degree/Diploma/Certificate)

• Masters degree in radiochemistry, or related field. Consideration will also be given to candidates with a PhD in chemistry or related discipline. 

Certification/Licensure/Registration

• Required to be designated as a Nuclear Energy Worker relative to applicable Canadian Nuclear Safety Commission (CNSC) legislation.

Qualifications and Skills

• Demonstrated ability to work in a highly regulated environment.
• Excellent oral and written communication skills, including demonstrated skills in technical writing.
• Self-motivation with the ability to analyze situations, set priorities and meet deadlines while maintaining attention to detail in a fast-paced and dynamic environment.
• An ability to work well both independently and within and across teams.
• Competency with computer applications such as Microsoft Office and information and document management systems.
• A high level of professionalism demonstrated by an ability to communicate effectively and to develop and maintain respectful and collaborative relationships with a wide variety of individuals including team members, academic and industry researchers, service providers and stakeholders.
• An ability to reflect, clarify and commit to what is important, take responsibility for growth and development, and contribute to positive and productive work and learning environments.
• Obtaining a “Certificate of Competence” in the Transport of Radioactive Dangerous Goods. 
• Obtaining an IATA Training Certificate for shipment of dangerous goods. 

Physical Requirements

• Ability to perform the essential physical requirements of the position.
• The incumbent may be exposed to radiation (which will be kept as low as reasonably achievable).
• Should be willing to work off hours, nights, week days and weekends.
• The incumbent will be required to come in at night to produce radiopharmaceuticals (run the cyclotron, load with reagents and run ASU) for supply to clinical and research imaging programs.
• Physically able to lift lead transfer pots weighing up to 25 pounds.