Job Summary:

In accordance with the Mission, Vision and Values, and strategic directions of Provincial Health Services Authority patient safety is a priority and a responsibility shared by everyone at PHSA. As such, the requirement to continuously improve quality and safety is inherent in all aspects of this position.

The Radiochemist Supervisor performs supervisory, administrative and technical duties within the Functional Imaging Department. Duties include supervising designated staff, coordinating the work activities related to the clinical and research production, overseeing the quality of the work performed, participating in planning and development of new radiotracers, developing and instructing staff in the use of new protocols/procedures and equipment, and providing training and daily guidance to Radiochemists.

The Radiochemist Supervisor also prepares and tests Good Manufacturing Practice (GMP) - compliant radiopharmaceuticals, documents all the results following approved procedures and protocols, and coordinates the production of the required quantity of radioisotopes from the cyclotron. The Radiochemist Supervisor coordinates maintenance and troubleshooting of the equipment used in GMP production, assists with the development and review of standard operating procedures (SOPs), and provides orientation and training to new radiochemistry staff. The Radiochemist Supervisor coordinates research activities with external groups, contributing to the preparation of scientific papers, grants applications, and regulatory submissions as required. The Radiochemist Supervisor reports directly to the Production Manager but may receive supervisory instructions from the Quality Assurance Manager when performing QC duties.

Duties/Accountabilities:

1. Supervises and co-ordinates the work activities of designated staff by performing duties such as scheduling, establishing priorities, providing guidance/technical advice, facilitating workplace solutions with other supervisory personnel, determining training and orientation needs, provides input into performance evaluations, referring disciplinary issues requiring formal written documentation to the department management and monitoring operations to ensure departmental standards are met and safety procedures are followed; participates as a member of an interview panel for candidate selection.

2. Prepares radiopharmaceuticals for human use following established procedures and GMPs. Coordinates the production of the required quantity of radioisotopes from the cyclotron depending on scheduled patient workload and external deliveries.

3. Performs QC measurements using various analytical chemistry techniques and equipment for verifying the quality of raw materials and final products. Performs QC testing on radiopharmaceutical final products, documents results, and reports results to the QA Manager and QA team.

4. Insures that material and consumable inventory is regularly performed, including overseeing the inspection and release of incoming materials according to approved specifications.

5. Performs and organizes routine maintenance as needed or scheduled on related equipment such as the automated synthesis modules, gas chromatograph, HPLC systems, TLC scanner and other similar equipment.

6. Completes all required documentation and records to meet the requirements of current GMP regulations and in compliance with Good Documentation Practices.

7. Performs validation and qualification of equipment as required prior to releasing for routine use in radiopharmaceutical production and QC.

8. Assists in development of new SOPs related to radiopharmaceutical production and QC in the facility as a GMP-compliant producer/distributor of PET radiopharmaceuticals.

9. Assists in development of new production and QC methods for clinical and research radiopharmaceuticals and helps prepare/present associated research papers, grant applications, and regulatory submissions.

10. Performs cleaning and monitoring of environmentally controlled areas.

11. Provides orientation and training to new Radiochemists for job duties as required. Accompanies contractors, guests, and other non-certified personnel in environmentally controlled areas when necessary.

12. Performs other related duties as assigned.

Qualifications:

Education, Training and Experience

• A combination of education, training, and experience, equivalent to a Bachelor’s degree in Chemistry or Pharmaceutical Sciences and a minimum of five (5) years recent related experience in a radiopharmaceutical and/or GMP laboratory. Current certification for the Transportation of Dangerous Goods (Class 7 Radioactive Materials) would be an asset.

Skills and Abilities

• Demonstrated ability in safe handling of radioactive materials
• Demonstrated synthetic chemistry or radiochemistry skills
• Working knowledge of analytical chemistry techniques
• Demonstrated ability to supervise, teach and train staff in GMP manufacturing environments
• Demonstrated ability to develop procedure protocols and manuals
• Demonstrated ability to work independently and in collaboration with others
• Demonstrated ability to establish workload priorities in collaboration with others
• Demonstrated technical writing ability and strong attention to detail
• Demonstrated ability to address issues with analytical reasoning and problem solving skills
• Excellent time management skills
• Demonstrated ability to communicate effectively, both verbal and in writing
• Physical ability to carry out the duties of the position.