Advisor, Analytical Chemistry
Eli Lilly and Company
August 07, 2026
On-site
Indianapolis, IN
Operations
Key Responsibilities
- Lead design, development, and optimization of analytical methods for radiopharmaceutical API/drug products (small molecules, peptides, radiolabeled compounds).
- Develop/optimize chromatographic (HPLC, UPLC, TLC, GC) and spectroscopic methods (gamma spectroscopy, MS, UV/Vis, NMR) and apply ICH Q14/Q2(R2) and USP/EP requirements.
- Troubleshoot analytical method performance issues; implement robust validated solutions.
- Author method validation protocols/reports (ICH Q2(R2), USP and regulatory guidance); lead qualification/validation at internal sites and CDMOs.
- Perform/oversee technology transfer to QC release/stability labs; prepare comparability and transfer qualification reports.
- Author analytical sections of CMC submissions (INDs, CTAs, NDA/BLA, MAA); justify specs; respond to regulatory inquiries.
- Ensure analytical activities comply with cGMP/cGLP and applicable FDA/EMA/Health Canada/ICH/USP/PDA standards; support OOS investigations.
Basic Requirements
- Bachelor’s degree in chemistry/analytical/organic chemistry.
- 10+ years GMP analytical development/validation/testing.
- Demonstrated ICH Q2(R2)-compliant validation of chromatographic and spectroscopic methods.
- Knowledge of GMP and FDA/EMA/ICH/USP/PDA guidelines.
- Proficiency with analytical data systems/lab informatics (e.g., Empower, Chromeleon, MassLynx).
- Strong oral/written communication.
Additional Preferences
- MS (5+ years) or PhD (2+ years); biotech/pharma hands-on.
- Radiopharmaceutical testing experience (radiometric HPLC, radiometric TLC, gamma spectroscopy for PET F-18 and/or Lu-177/Ac-225).
Other Information
- PPE/radiological safety protocols; travel 5–15%.
Compensation/Benefits (if applicable)
- Anticipated wage: $126,000–$204,600; eligibility for company bonus; participation in 401(k), pension, and comprehensive medical/dental/vision and other benefits.
- Lead design, development, and optimization of analytical methods for radiopharmaceutical API/drug products (small molecules, peptides, radiolabeled compounds).
- Develop/optimize chromatographic (HPLC, UPLC, TLC, GC) and spectroscopic methods (gamma spectroscopy, MS, UV/Vis, NMR) and apply ICH Q14/Q2(R2) and USP/EP requirements.
- Troubleshoot analytical method performance issues; implement robust validated solutions.
- Author method validation protocols/reports (ICH Q2(R2), USP and regulatory guidance); lead qualification/validation at internal sites and CDMOs.
- Perform/oversee technology transfer to QC release/stability labs; prepare comparability and transfer qualification reports.
- Author analytical sections of CMC submissions (INDs, CTAs, NDA/BLA, MAA); justify specs; respond to regulatory inquiries.
- Ensure analytical activities comply with cGMP/cGLP and applicable FDA/EMA/Health Canada/ICH/USP/PDA standards; support OOS investigations.
Basic Requirements
- Bachelor’s degree in chemistry/analytical/organic chemistry.
- 10+ years GMP analytical development/validation/testing.
- Demonstrated ICH Q2(R2)-compliant validation of chromatographic and spectroscopic methods.
- Knowledge of GMP and FDA/EMA/ICH/USP/PDA guidelines.
- Proficiency with analytical data systems/lab informatics (e.g., Empower, Chromeleon, MassLynx).
- Strong oral/written communication.
Additional Preferences
- MS (5+ years) or PhD (2+ years); biotech/pharma hands-on.
- Radiopharmaceutical testing experience (radiometric HPLC, radiometric TLC, gamma spectroscopy for PET F-18 and/or Lu-177/Ac-225).
Other Information
- PPE/radiological safety protocols; travel 5–15%.
Compensation/Benefits (if applicable)
- Anticipated wage: $126,000–$204,600; eligibility for company bonus; participation in 401(k), pension, and comprehensive medical/dental/vision and other benefits.