Lead Analytical Chemist – Radiopharmaceuticals

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 126,000 - 205,000; Full time

Benefits offered by this job

Bonus eligibility

401(k) retirement plan

Medical, dental, vision benefits

Job summary

Lilly is seeking an Advisor, Analytical Chemist within the Radiopharmaceuticals CM&C Technical Operations group in Indianapolis. The role leads analytical method development, validation, and technology transfer to support late-phase radiopharmaceutical programs with GMP compliance.

You will collaborate across QC, Regulatory, manufacturing, and external CDMOs, author method validation reports, and ensure readiness for regulatory submissions and commercial launches.

Qualifications

• Earned Bachelor's degree in chemistry, analytical chemistry, or organic chemistry.
• 10+ years of relevant experience in analytical development/validation/testing in GMP.
• Expertise in validating chromatographic and spectroscopic methods per ICH/Q2(R2).
• GMP regulations and regulatory guidelines knowledge.
• Strong cross-functional collaboration and project management skills.
• Proficiency with Empower, Chromeleon, and MassLynx.

Responsibilities

• Lead analytical method development and optimization for radiopharmaceuticals.
• Author validation protocols and transfer methods to QC labs.
• Prepare and review regulatory submission documents and reports.
• Ensure compliance with cGMP, ICH, USP, and regulatory expectations.
• Collaborate with QC, Regulatory, Manufacturing, and CDMOs.

Skills

Analytical method development

cGMP

Cross-functional collaboration

Project management

Mass spectrometry

HPLC/UPLC

Gamma spectroscopy

Regulatory submissions

Education

Bachelor's degree in chemistry or related field

Master's or PhD in chemistry (preferred)

Tools

Empower

Chromeleon

MassLynx

HPLC/UPLC instruments

Gamma spectroscopy instrumentation

Job description

Lilly is seeking an Advisor, Analytical Chemist within the Radiopharmaceuticals CM&C Technical Operations group in Indianapolis. The role leads analytical method development, validation, and technology transfer to support late-phase radiopharmaceutical programs with GMP compliance.

You will collaborate across QC, Regulatory, manufacturing, and external CDMOs, author method validation reports, and ensure readiness for regulatory submissions and commercial launches.