Description:
TRIUMF, Canada’s premier particle accelerator centre, is seeking an experienced and highly skilled Radiopharmaceutical Quality Control Supervisor to support its Institute for Advanced Medical Isotopes (IAMI) program. This permanent, full-time position offers a unique opportunity to contribute to cutting-edge research and play a vital role in the production of life-saving medical isotopes and radiopharmaceuticals.
As a Quality Control Supervisor, you will be responsible for overseeing and executing quality control testing on injectable radiopharmaceuticals and radioisotopes prepared for the IAMI program. You will collaborate with multidisciplinary teams, uphold Good Manufacturing Practices (GMP), and ensure that all quality control processes meet the highest standards. The successful candidate will bring advanced radiochemistry expertise, exceptional organizational skills, and demonstrated experience in laboratory quality management.
Key Responsibilities:
- Supervise and regularly perform daily quality control testing of radioisotopes and radiopharmaceuticals.
- Establish Quality Control documentation for each production batch, ensuring accurate and complete records.
- Develop, maintain, and update Standard Operating Procedures (SOPs) and Standard Test Methods (STMs) related to radiopharmaceutical quality control.
- Maintain supplies and inventory records for quality control materials, including precursors, chemicals, and reagents.
- Develop and manage a vendor qualification program to ensure high-quality supplies and materials.
- Maintain training records for quality control technicians and operators, ensuring staff competence and compliance.
- Oversee general laboratory organization, including storage management, housekeeping, and regular database updates.
- Manage and maintain the environmental control program, ensuring compliance with regulatory requirements.
- Analyze and monitor key performance indicators (KPIs) such as quality control test results and environmental data to identify trends and drive continuous process improvements.
- Train laboratory technicians in safe, GMP-compliant quality control processes and proper documentation practices.
- Collaborate closely with the PET Production Supervisor and other team members to maintain seamless operations and high product quality.
Supervisory Responsibilities:
Initially, supervisory responsibilities will be shared with the PET Production Supervisor. However, as the IAMI team grows, the Quality Control Supervisor will directly supervise dedicated quality control technicians.
Required Knowledge & Skills:
- Expert knowledge of general chemistry and radiochemistry.
- Strong analytical chemistry expertise, including the use of HPLC, radio-TLC, and GC.
- Excellent oral and written communication skills.
- Exceptional organizational and meticulous record-keeping abilities.
- High attention to detail with precise laboratory techniques.
- Advanced proficiency in Microsoft Office Suite and laboratory software.
- Strong collaboration and supervisory skills.
- Familiarity with GMP regulations and sterile pharmaceutical practices (an asset).
Nuclear Energy Worker Requirement:
This position requires designation as a Nuclear Energy Worker (NEW). TRIUMF will provide all necessary training for the successful candidate.
Minimum Qualifications:
- PhD in Chemistry, ideally with a specialization in Radiochemistry.
- Minimum of 8 years of professional experience, including at least 5 years of practical, lab-based radiochemistry experience.
- Hands-on experience working with multiple radionuclides, including radiometals.
- Proven expertise in the operation and maintenance of analytical equipment such as HPLC, radio-TLC, and GC.
Total Rewards Package:
TRIUMF offers a comprehensive benefits package including:
- TRIUMF-paid dental, extended health, vision care, emergency travel assistance, Employee Assistance Program (EAP), Life Insurance, and Wellness Benefits.
- Excellent Employee Pension Plan.
- Disability benefits and optional additional Life Insurance and Accidental Death & Dismemberment (AD&D) coverage.
- Generous vacation and time-off policies.
- Maternity and paternity leaves with top-ups.