Analytical Scientist
STEM Diverse Talent Solutions
On-site
Indianapolis, Indiana, United States
Laboratory Scientist
The Analytical Scientist will play a key role in supporting drug substance and drug product development for radiopharmaceutical programs. This position is responsible for developing, validating, and executing analytical methods that ensure product quality, safety, compliance, and consistency across development and manufacturing stages. The ideal candidate has strong hands-on experience with analytical instrumentation, GMP/GLP environments, and enjoys working cross-functionally in a fast-paced biotech setting.
Key Responsibilities
- Develop, optimize, and validate analytical methods (e.g., HPLC, UPLC, GC, ICP-MS, LC-MS, radio-HPLC) to characterize small molecules, peptides, and radioconjugates.
- Perform routine and non-routine testing of raw materials, intermediates, reference standards, drug substance, and radiopharmaceutical drug products.
- Support stability studies, impurity profiling, release testing, and development of specifications.
- Author and review technical documents including method development reports, validation protocols, SOPs, and regulatory submission sections.
- Collaborate with cross-functional teams including Process Development, Quality, Manufacturing, and Radiochemistry.
- Troubleshoot analytical instrumentation and ensure calibration, maintenance, and documentation are compliant with industry standards.
- Support regulatory filings (IND, NDA, IMPD) by providing high-quality analytical data and documentation.
- Ensure compliance with GLP/GMP requirements, data integrity expectations, and quality systems.