Radiopharmaceuticals Analytical Chemistry Advisor

100 Eli Lilly and Company

Indianapolis (IN)

On-site

USD 126,000 - 205,000

Full time

3 days ago
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Benefits offered by this job

401(k) plan
Pension
Medical insurance
Dental insurance
Vision insurance
Well-being program

Job summary

Lilly in Indianapolis is seeking an Advisor, Analytical Chemist in the Radiopharmaceuticals RLT CM&C group. This role leads the design, development, validation, and transfer of analytical methods to support late‑phase programs and regulatory submissions.

You will ensure GMP, ICH, USP readiness and act as the analytical SME across cross‑functional teams. Collaborating with QC, CMC Regulatory, Manufacturing Sciences, and external CDMOs, you will drive method strategies, troubleshoot complex

Qualifications

  • Bachelor's degree in chemistry or related field with 10+ years in analytical GMP setting.
  • Expertise in HPLC/UPLC, gamma spectroscopy, MS, UV/Vis, and radiochemical methods.
  • Strong knowledge of ICH, USP, GMP requirements for late‑phase programs.

Responsibilities

  • Lead analytical method development, validation, and transfer for radiopharmaceutical programs.
  • Prepare regulatory‑compliant method descriptions and validation reports.
  • Collaborate cross‑functionally with QC, CMC Regulatory, and external CDMOs.
  • Troubleshoot complex analytical issues and drive continuous improvement.
  • Support inspections and regulatory submissions with technical input.

Skills

Analytical method development
Analytical method validation
Method transfer
GMP compliance
Regulatory submissions (CMC)
Cross-functional collaboration
HPLC/UPLC
Mass spectrometry

Education

Bachelor's degree in chemistry
Master's degree in chemistry
PhD in chemistry

Tools

Empower
Chromeleon
MassLynx

Job description

Lilly in Indianapolis is seeking an Advisor, Analytical Chemist in the Radiopharmaceuticals RLT CM&C group. This role leads the design, development, validation, and transfer of analytical methods to support late‑phase programs and regulatory submissions.

You will ensure GMP, ICH, USP readiness and act as the analytical SME across cross‑functional teams. Collaborating with QC, CMC Regulatory, Manufacturing Sciences, and external CDMOs, you will drive method strategies, troubleshoot complex

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