Specialist - Radio Chemist

Avenue.io Inc.; Calgary; On-site; CAD 53,000 - 92,000; Full time

Job summary

Avenue.io Inc. is seeking a Radiochemist to lead the Radiopharmacy program within the TracerHUB Calgary Radiopharmaceutical Centre at Foothills Medical Centre.

The role involves supervising synthesis, QC, and regulatory activities to support high-volume GMP manufacturing for clinical and research use. Responsibilities include developing and validating radiolabeling methods (F-18, Tc-99m, Ga-68, Cu-64, Zr-89), ensuring product quality and safety, and driving compliance with Health Canada and CNSC

Qualifications

• Ph.D. in Radiochemistry, Chemistry, Biology, or a related scientific discipline with 3–5 years of laboratory radiochemistry or radiopharmacy experience.
• M.S. with 5–7 years of relevant radiopharmacy experience considered as alternative.
• Extensive hands-on experience with automated synthesis units, cleanroom/aseptic techniques, and QC instrumentation (HPLC, TLC, GC, gamma spectroscopy, LAL endotoxin testing).

Responsibilities

• Lead development, translation, and validation of radiopharmaceuticals from R&D to clinical translation.
• Supervise GMP manufacturing to meet clinical and commercial demand; operate equipment and write SOPs.
• Ensure regulatory compliance under cGMP, Health Canada, and CNSC; support licensing and regulatory submissions.

Education

Ph.D. in Radiochemistry, Chemistry, Biology, or related discipline

M.S. in Radiochemistry or related field

Tools

Automated synthesis units

HPLC

TLC

Gas chromatography

Gamma spectroscopy

LAL endotoxin testing

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.