Radiochemist

Position Overview

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

• Managing the technical operations of the PERs lab at the Winnipeg Cyclotron Facility, including production of PERs batches for both clinical and research use. This includes the whole cycle from cyclotron production of radioisotopes, to radiopharmaceutical manufacturing to quality control testing.
• Day-to-day supervision of the cyclotron program technical staff, including setting staffing schedules and participating in staff evaluations and performance improvement plans.
• Acting as the subject matter expert (SME) in matters related to the production and quality control testing of PERs, including supporting Quality Program investigations of nonconformances in the manufacture and testing of PERs products.
• Implementation of production and quality control testing of new PERs products for clinical and research use in collaboration with the Quality Program.
• Maintenance of training program for cyclotron facility technical staff.
• Working with the Quality Program of the Radiopharmaceutical Production Program to ensure that compliance is maintained with all applicable regulatory bodies, including: CNSC, Health Canada, Transport Canada and other applicable national and provincial regulatory standards and guidelines.
• Fostering and supporting research activities within the PET Radiochemistry Program in collaboration with Nuclear Medicine and other clinical and basic science departments.
• Reviews trends in PERs production results and works with Quality Program to implement process improvements to correct negative trends.
• Reports to management on the status of the Winnipeg Cyclotron Facility technical program and identifies alternatives and strategies for the delivery of PERs manufacturing and quality control testing practices.
• Working with the Quality Program to keep Standard Operation Procedures (SOPs) current for program activities.
• Working with the Quality Program to ensure that product manufacturing and quality control testing is consistent with product monograph, reference product or master drug files.
• Keeps up-to-date on current CNSC and Health Canada regulations related to PERs programs and responds to proposed changes as may be appropriate according to the likely impact on program operation.
• With the Radiation Safety Officer (RSO) reviews regularly staff radiation doses and takes steps necessary to ensure that no staff receive a radiation dose in excess of the permitted for a Nuclear Energy Worker, nor in excess of what is consistent with person specific limitations.
• 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.
• Works with the Program Director to review production costs and determine appropriate pricing for products requested by clinical or research partners.
• Leads the technical aspects of equipment selection, installation and qualification for the cyclotron program.
• Ensures and supports continuing education amongst professional, technical and clerical cyclotron program staff.
• Works collaboratively with the Technical Coordinator, Central Radiopharmacy to provide professional coverage.
• Contributes to PERs related research and development activity through both internal and interdepartmental projects.
• Other duties as assigned.

Experience

• A minimum of 3 years’ experience at the post-doctoral or staff level 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.
• 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)

• PhD in radiochemistry, radiopharmacy or related field. Consideration will also be given for a PhD in chemistry (organic chemistry preferred).
• Doctoral or post-doctoral thesis or publications related to positron emitting radiopharmaceuticals (PERs) preferred.

Certification/Licensure/Registration

• Required to be designated as a Nuclear Energy Worker relative to applicable Canadian Nuclear Safety Commission (CNSC) legislation.
• Eligibility for licensure as a pharmacist in the Province of Manitoba or another jurisdiction will be considered an asset.
• Candidate must be eligible and successful in obtaining a University of Manitoba academic position (rank determined by level of experience).

Qualifications and Skills

• Demonstrated project management skills 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.
• Demonstrated track record in applying for and being awarded grant applications preferred.

Physical Requirements

• Good physical and mental health. 
• The incumbent may be exposed to radiation (which will be kept as low as reasonably achievable).