08 Nov
|
590 Point Canada
|
Toronto
08 Nov
590 Point Canada
Toronto
Lead radiopharmaceutical analytical chemistry at Lilly, advancing method development and validation for phase 1b through phase 3 programs. This technical role supports GMP readiness.
The Advisor, Analytical Chemist serves as the primary analytical chemistry subject matter expert within RLT Chemistry, Manufacturing & Controls Technical Operations. You will guide chromatographic and spectroscopic methods, regulatory documentation, and analytical readiness. Collaboration spans QC, CMC Regulatory, manufacturing, and external CDMO partners.
Key Responsibilities:
- Lead analytical method development for APIs and drug products
- Optimize HPLC, UPLC, TLC, GC, and spectroscopic methods
- Author validation protocols, reports, and regulatory submission sections
- Transfer validated methods to QC laboratories and CDMOs
- Support investigations, audits, and analytical technology improvements
Requirements:
- Bachelor's degree in chemistry, analytical chemistry, or organic chemistry
- 10+ years in GMP analytical development, validation, or testing
- Expertise validating chromatographic and spectroscopic analytical methods
- Knowledge of GMP, FDA, EMA, ICH, USP, and PDA guidelines
- Canadian citizenship and solid technical communication skills
Apply analytical chemistry expertise, method validation leadership, and GMP knowledge to Lilly radiopharmaceutical programs and regulatory readiness.
📌 Advisor Analytical Chemistry Radiopharmaceuticals (Toronto)
🏢 590 Point Canada
📍 Toronto