Advisor, Analytical Chemistry

Advisor, Analytical Chemist

At Lilly, we serve an extraordinary purpose — we make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. The Radiopharmaceuticals (RLT) Chemistry, Manufacturing & Controls (CM&C) group is at the forefront of advancing therapeutic radiopharmaceuticals from clinical development through commercial launch.

The Advisor, Analytical Chemist is a critical technical role within the RLT CM&C Technical Operations function. Reporting to the Senior Director, Technical Operations, this position leads the technical transfer, development, optimization, and validation of analytical methods to support phase 1b to phase 3 radiopharmaceutical programs. The Advisor serves as the primary analytical chemistry subject matter expert (SME), driving scientifically sound, phase-appropriate method strategies that meet GMP, ICH, USP, and regulatory expectations.

This role operates at the intersection of analytical science, regulatory compliance, and cross-functional program delivery — collaborating closely with QC, CMC Regulatory, manufacturing, and external CDMO partners to ensure analytical readiness for late-phase development milestones and regulatory submissions.

• Analytical Method Development & Optimization
• Lead the design, development, and optimization of analytical methods for radiopharmaceutical API and drug products, including small molecules, peptides, and radio labeled 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 for late clinical phase through commercial programs.
• Identify and implement analytical technology improvements and method modernization initiatives to support continuous improvement and commercial readiness.
• Troubleshoot complex analytical method performance issues and implement robust, validated solutions.
• Analytical Method Validation & Transfer
• Author method validation protocols and reports in full compliance with ICH Q2(R2), USP , and applicable regulatory guidance for late-phase and commercial programs.
• Lead analytical method qualification and validation activities at internal sites and external CDMOs/partners.
• Perform or oversee technology transfer of validated methods to QC release and stability testing laboratories.
• Prepare and review method transfer protocols, comparability studies, and qualification/validation reports.
• Ensure validation data packages are complete, defensible, and ready for regulatory submission.
• Regulatory & Documentation
• Author analytical sections of CMC regulatory submissions (INDs, CTAs, NDA/BLA, MAA), including method descriptions, validation summaries, and specification justifications.
• Develop and justify release and stability specifications for starting materials, intermediates, and drug products in collaboration with CMC Regulatory and QA.
• Prepare responses to regulatory agency inquiries related to analytical methods and specifications.
• Author and review standard test methods, SOPs, change controls, and technical reports in accordance with GMP and Good Documentation Practices.
• Support internal and external GMP audits, providing technical analytical expertise as required.
• GMP Quality & Compliance
• Ensure all analytical activities are conducted in compliance with cGMP, cGLP, applicable FDA, EMA, Health Canada, ICH, USP, PDA, and Lilly quality standards.
• Review and approve experimental data from internal labs and external CDMOs/vendors; interpret results and document conclusions accurately.
• Lead or support investigations of out-of-specification (OOS) results, analytical deviations, and aberrant data using robust root cause analysis methodology.
• Cross-Functional Collaboration & External Partnerships
• Serve as the analytical chemistry SME for late-phase RLT programs, providing technical direction to cross-functional CMC teams.
• Build and maintain productive working relationships with internal, external CDMOs, analytical service providers, and regulatory partners.
• Collaborate with QC, CMC Regulatory, Manufacturing Sciences, and Supply Chain to ensure seamless analytical readiness for clinical and commercial supply.
• Represent analytical capabilities in project team meetings, technical reviews, and governance forums.

• Earned Bachelor's degree in chemistry, analytical chemistry, or organic chemistry
• 10+ years of relevant experience in analytical development, analytical validation, and/or analytical testing in a GMP setting.
• Demonstrated expertise in the development and full ICH Q2(R2)-compliant validation of chromatographic (HPLC, UPLC, GC, TLC) and spectroscopic (MS, UV/Vis, gamma) analytical methods.
• Functional knowledge of GMP regulations and applicable FDA, EMA, ICH, USP, and PDA…