Original job description
Your Opportunity:
Within the provincial Tracer HUB Team and serving in a multi-disciplinary leadership role, the Radiochemist oversees the end-to-end lifecycle of diagnostic and therapeutic radiopharmaceuticals to establish a self-sufficient Radiopharmacy program in collaboration with the University of Calgary. This position bridges clinical R&D and routine manufacturing by driving the research, translation, and validation of novel agents while ensuring strict, high-volume production compliance under Good Manufacturing Practices (GMP), Health Canada, and CNSC regulatory frameworks.
Description:
Program & R&D Leadership: Spearhead the development of the Radiopharmacy program. Supervise the development, optimization, and validation of synthesis, purification and Quality Control methods for novel PET/SPECT radiopharmaceuticals. Manufacturing & Operations: Supervise and support GMP manufacturing to meet clinical and commercial demand. Operate automated synthesis units, lead equipment selection and validation, write SOPs, and serve as an operational cyclotron operator as needed for clinical translation work. Radiochemistry and Quality Control (QC) Expertise: Formulate doses and execute a broad range of isotope labeling chemistries, including F-18, Tc-99m, radioiodination, and radiometal chelation (e.g., Ga-68, Cu-64, Zr-89). Develop and validate analytical methods to evaluate release criteria and ensure every batch meets safety, purity, and regulatory standards. Regulatory & Quality Compliance: Direct compliance under cGMP, Health Canada, and CNSC guidelines. Drive licensing processes for CNSC construction and validation, Health Canada Drug Establishment Licenses (DEL), New Drug Submissions (NDS), and Clinical Trial Applications (CTA). Team Training & Mentorship: Train and mentor Radiopharmacy Specialists and Technologists on production workflows, equipment operation, safety protocols, and QC procedures.
Classification: Specialist Union: Exempt Unit and Program: TracerHUB/Calgary Radiopharmaceutical Centre Primary Location: Foothills Medical Centre Location Details: As Per Location Employee Class: Regular Full Time FTE: 1.00 Posting End Date: 20-NOV-2026 Date Available: 11-JAN-2027 Hours per Shift: 7.75 Length of Shift in weeks: 1 Shifts per cycle: 5 Shift Pattern: Days, On Call Days Off: Saturday/Sunday Minimum Salary: $38.73 Maximum Salary: $66.42 Vehicle Requirement: Not Applicable
Required Qualifications:
Education & Experience: Ph.D. in Radiochemistry, Chemistry, Biology, or a related scientific discipline with 3–5 years of laboratory (radiochemistry or radopharmacy) experience, or an M.S. with 5–7 years of relevant experience.
Additional Required Qualifications:
Technical Proficiency: Extensive hands-on experience with automated synthesis units, cleanroom/aseptic techniques, and analytical QC instrumentation (HPLC, TLC, gas chromatography, gamma spectroscopy, and LAL endotoxin testing). Proven ability to troubleshoot instrument malfunctions
Preferred Qualifications:
Regulatory Knowledge: Deep understanding of cGMP requirements, Health Canada/CNSC regulatory frameworks, and Chemistry, Manufacturing, and Controls (CMC) documentation. Core Competencies: Priority will be given to candidates with direct experience producing radiopharmaceuticals for human use. Strong safety record in hazardous/radioactive environments, excellent project management skills, adaptability, and clear communication abilities. Prior supervisory experience is preferred.
More about this job
Responsibilities
Lead the development of a Radiopharmacy program and oversee research, translation, validation, and GMP manufacturing of diagnostic and therapeutic radiopharmaceuticals. Direct quality and regulatory compliance, licensing and documentation activities, and train and mentor Radiopharmacy staff.
Requirements
Requires a Ph.D. in a relevant scientific discipline with 3–5 years of radiochemistry or radiopharmacy laboratory experience, or an M.S. with 5–7 years of relevant experience. Candidates need hands-on expertise with automated synthesis equipment, cleanroom and aseptic techniques, analytical QC instruments, and troubleshooting; direct human-use production experience and supervisory experience are preferred.
Skills
- Radiochemistry
- Radiopharmaceutical Manufacturing
- Radiopharmacy Program Development
- Radiopharmaceutical Synthesis
- Quality Control
- Good Manufacturing Practices
- Automated Synthesis Units
- Aseptic Techniques
- HPLC
- Thin-Layer Chromatography
- Gas Chromatography
- Gamma Spectroscopy
- LAL Endotoxin Testing
- Regulatory Compliance
- Method Validation
- Team Training and Mentorship
Visa sponsorship
Not detected in the job text
Categories
- Science & Research
- Healthcare
- Manufacturing
- Management & Leadership
- Security & Safety
Keywords
- Radiochemistry
- Radiopharmacy
- Radiopharmaceuticals
- PET
- SPECT
- F-18
- Tc-99m
- Radioiodination
- Radiometal Chelation
- Ga-68
- Cu-64
- Zr-89
- GMP
- cGMP
- Health Canada
- CNSC
- Drug Establishment License
- New Drug Submission
- Clinical Trial Application
- Chemistry, Manufacturing, and Controls
- Automated Synthesis Units
- Cleanroom
- Aseptic Techniques
- HPLC
- Thin-Layer Chromatography
- Gas Chromatography
- Gamma Spectroscopy
- LAL Endotoxin Testing
- Cyclotron
- Standard Operating Procedures
