Advisor Analytical Chemistry Radiopharmaceuticals

1 day ago

Canada 590 Point Canada Full-time

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 strong technical communication skills

Apply analytical chemistry expertise, method validation leadership, and GMP knowledge to Lilly radiopharmaceutical programs and regulatory readiness.