Senior Analytical Chemist, Radiopharmaceuticals – Late-Phase

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

Benefits offered by this job

401(k) plan with company match

Paid time off and holidays

Medical, dental, vision benefits

Job summary

Eli Lilly and Company in Indianapolis, IN, is seeking an Advisor, Analytical Chemist to lead analytical method development and validation for radiopharmaceutical programs from late-stage clinical to commercial readiness. You will work across QC, Regulatory, and external CDMOs to ensure analytical readiness for regulatory submissions.

The role emphasizes chromatographic and spectroscopic method development (HPLC/UPLC, gamma spectroscopy, MS, UV/Vis) in a GMP environment, with collaboration across

Qualifications

• Bachelor's degree in chemistry or analytical chemistry.
• 10+ years' GMP analytical development/validation experience.
• Experience with chromatographic/spectroscopic methods.
• Knowledge of GMP, FDA/EMA/ICH guidelines relevant to analytics.

Responsibilities

• Lead analytical method development and validation for radiopharmaceutical programs.
• Oversee method transfer to QC release and stability labs.
• Prepare and review method validation reports and regulatory submissions.
• Collaborate with QC, Regulatory, Manufacturing, and external CDMOs.

Skills

Analytical method development

Cross-functional collaboration

ICH Q2(R2) compliance

Regulatory submissions support

GMP/good documentation practices

Analytical data systems (Empower)

Education

Bachelor's degree in chemistry/analytical chemistry

Master's or PhD in chemistry (preferred)

Tools

Empower

Chromeleon

MassLynx

Job description

Eli Lilly and Company in Indianapolis, IN, is seeking an Advisor, Analytical Chemist to lead analytical method development and validation for radiopharmaceutical programs from late-stage clinical to commercial readiness. You will work across QC, Regulatory, and external CDMOs to ensure analytical readiness for regulatory submissions.

The role emphasizes chromatographic and spectroscopic method development (HPLC/UPLC, gamma spectroscopy, MS, UV/Vis) in a GMP environment, with collaboration across