Principal Scientist, Analytical Sciences

Responsibilities

• Implement Orna’s analytical testing strategy for circular RNA and lipid nanoparticle formulations with a focus on chromatography methods.
• Develop and qualify drug substance and drug product analytical methods and perform characterization studies.
• Build and develop internal analytical capabilities to support in-process, release, stability, and characterization testing of drug products.
• Perform regular maintenance on HPLCs and other laboratory instrumentation.
• Maintain a clean and safe laboratory environment.
• Support method transfers to Contract Research Organizations and provide technical guidance/troubleshooting.
• Review method procedures, method validation protocols, and reports.
• Generate, interpret, and present data to cross-functional R&D teams.
• Contribute to a positive and exciting work environment and a strong entrepreneurial and creative culture.

Requirements

• BS degree in analytical chemistry, biochemistry, or a similar area, with 6-9 years of relevant experience in analytical method development.
• Or MS degree in analytical chemistry, biochemistry, or a similar area with 3+ years of relevant experience in analytical method development.
• Experience with HPLC/UPLC and related software is required.
• Experience with development, qualification, validation, and transfer of analytical methods in a GxP environment to support process development, product characterization, release, stability studies, and other analytical studies.