Lead Analytical Chemist - Radiopharmaceuticals

BioSpace; Indianapolis (IN); On-site; USD 126,000 - 205,000; Full time

Job summary

Lilly in Indianapolis is seeking an Analytical Chemist to drive analytical method development, validation, and regulatory submissions for radiopharmaceuticals. This role emphasizes GMP compliance and cross-functional collaboration with QC, Regulatory, and Manufacturing teams.

You will lead method validation and tech transfer, ensuring robust data packages and regulatory readiness for late-stage programs and commercial supply. Strong communication and problem-solving skills are essential.

Qualifications

• Bachelor's degree in chemistry or related field required.
• 10+ years in analytical development/validation in GMP environment.
• Proven experience with chromatographic/spectroscopic methods (HPLC/UPLC/GC/TLC; MS, UV/Vis, NMR).
• Strong GMP regulatory knowledge and ability to support regulatory submissions.

Responsibilities

• Lead design, development, and optimization of analytical methods for radiopharmaceuticals.
• Author method validation protocols and reports per ICH Q2(R2) and USP guidelines.
• Coordinate technology transfer to QC labs and CDMOs as needed.
• Prepare responses to regulatory inquiries and maintain compliant documentation.

Skills

Analytical method development

Method validation

Regulatory submissions

GMP knowledge

Cross-functional collaboration

Education

Bachelor's degree in chemistry

Tools

HPLC

UPLC

GC

TLC

MS

NMR

Job description

Lilly in Indianapolis is seeking an Analytical Chemist to drive analytical method development, validation, and regulatory submissions for radiopharmaceuticals. This role emphasizes GMP compliance and cross-functional collaboration with QC, Regulatory, and Manufacturing teams.

You will lead method validation and tech transfer, ensuring robust data packages and regulatory readiness for late-stage programs and commercial supply. Strong communication and problem-solving skills are essential.