Chemist • calgary ab
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... Show more
Disclaimer: SLB completed the acquisition of ChampionX on July 16, 2025.If selected for this position, your employment will begin with ChampionX and will transition to SLB as part of the planned in... Show more
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 (, 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.
Required Qualifications:
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.
