Lead Analytical Chemist, Radiopharmaceuticals

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 126,000 - 205,000; Full time

Benefits offered by this job

Travel flexibility

Accommodation support

Job summary

Lilly is seeking an Advisor, Analytical Chemist in Indianapolis to lead analytical method development, validation, and technology transfer for radiopharmaceutical programs from late clinical stages through commercialization.

You will serve as the analytical chemistry SME, guiding method strategies, ensuring GMP compliance, and coordinating with QC, Regulatory, and external CDMOs to readiness for regulatory submissions and manufacturing readiness.

Qualifications

• Bachelor's degree in chemistry; 10+ years in analytical development/validation/testing in GMP.
• Expertise in development and full ICH Q2(R2)-compliant validation of chromatographic and spectroscopic methods.
• GMP regulations and guidance (FDA/EMA/ICH/USP/PDA) knowledge for analytical testing.
• Ability to drive cross-functional projects with strong project management and organization.
• Proficiency with lab informatics (Empower, Chromeleon, MassLynx).

Responsibilities

• Lead development/optimization of analytical methods for radiopharmaceuticals.Develop chromatographic and spectroscopic methods for late-phase programs.
• Lead method validation/transfer activities and regulatory-ready data packages.
• Author analytical sections of regulatory submissions; support audits and CAPAs.
• Oversee GMP-compliant data and technical reports; manage external CDMOs/vendors.
• Collaborate with QC, Regulatory, Manufacturing Sciences, and Supply Chain.

Skills

Analytical Method Development

Method Validation

GMP Knowledge

Cross-functional Collaboration

Lab Informatics

Education

Bachelor's degree in Chemistry

Master's degree in Chemistry

PhD in Chemistry

Tools

Empower

Chromeleon

MassLynx

Job description

Lilly is seeking an Advisor, Analytical Chemist in Indianapolis to lead analytical method development, validation, and technology transfer for radiopharmaceutical programs from late clinical stages through commercialization.

You will serve as the analytical chemistry SME, guiding method strategies, ensuring GMP compliance, and coordinating with QC, Regulatory, and external CDMOs to readiness for regulatory submissions and manufacturing readiness.