- Toronto, Ontario, Canada
- Full-time · Senior
- 10+ years
A critical technical role within the RLT CM&C Technical Operations function leading the technical transfer, development, optimization, and validation of analytical methods to support phase 1b to phase 3 radiopharmaceutical programs.
Responsibilities
- Lead the design, development, and optimization of analytical methods for radiopharmaceutical API and drug products, including small molecules, peptides, and radiolabeled compounds.
- Develop and optimize chromatographic methods (HPLC, UPLC, TLC, GC) and spectroscopic methods (gamma spectroscopy, mass spectrometry, UV/Vis, NMR) as appropriate for late-phase programs.
- Apply phase-appropriate development strategies aligned with ICH Q14, ICH Q2(R2), and applicable USP/EP compendial requirements.
- Identify and implement analytical technology improvements and method modernization initiatives.
- Troubleshoot complex analytical method performance issues and implement robust, validated solutions.
Requirements
- Bachelor's degree in chemistry
- Bachelor's degree in analytical chemistry
- Bachelor's degree in organic chemistry
- Nice to have: Master's degree in chemistry field with 5+ years of relevant experience
- Nice to have: PhD in chemistry field with 2+ years of relevant experience