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, and as such, the requirement to continuously improve quality and safety is inherent in all aspects of this position.
The Radiochemist prepares and tests Good Manufacturing Practice (GMP) - compliant radiopharmaceuticals to meet the scheduled daily workload of BC Cancer’s Functional Imaging department. Working under limited supervision, this requires the daily coordination of the production of the required quantity of radioisotopes from the cyclotron, production of radiopharmaceuticals using automated synthesis modules, completion of required quality control (QC) tests, and documentation of all results following approved procedures and protocols. The Radiochemist troubleshoots and resolves technical equipment problems as necessary in order to maintain daily radiopharmaceutical output and clinical patient throughput. The Radiochemist assists with the development and review of standard operating procedures (SOPs) in order to maintain GMP-compliance for the facility as a producer/distributor of PET radiopharmaceuticals. Responsibilities also include providing orientation and training to new radiochemistry staff. The Radiochemist works collaboratively on research activities with external groups, contributing to the preparation of scientific papers, grants applications, and regulatory submissions as required. The Radiochemist reports directly to the Production Manager but may receive supervisory instructions from the Quality Assurance Manager when performing QC duties.

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 two (2) years recent related experience in a pharmaceutical or GMP laboratory. Current certification for the Transportation of Dangerous Goods (Class 7 Radioactive Materials) and work experience in a PET radiopharmaceutical laboratory 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 technical writing ability and strong attention to detail
• Ability to handle GMP manufacturing environments
• Demonstrated ability to collaborate in a team environment
• 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

1. Under limited supervision, 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.
2. Under limited supervision, 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.
3. Prepares the various reagents used in the syntheses and QC of radiopharmaceuticals.
4. Sends radiopharmaceutical samples to contact laboratory facilities for post-production testing.
5. Maintains raw material and consumable inventories as needed for daily radiopharmaceutical production. This includes the inspection and release of incoming materials according to approved specifications.
6. Performs 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.
7. Completes all required documentation and records to meet the requirements of current GMP regulations and in compliance with Good Documentation Practices.
8. Performs validation and qualification of equipment as required prior to releasing for routine use in radiopharmaceutical production and QC.
9. Develops new SOPs related to radiopharmaceutical production and QC in the facility as a GMP-compliant producer/distributor of PET radiopharmaceuticals.
10. 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.
11. Performs cleaning and monitoring of environmentally controlled areas.
12. Provides orientation and training to new Radiochemists for job duties as required. Supervises contractors, guests, and other non-certified personnel in environmentally controlled areas when necessary.
13. Performs other related duties as assigned.