Principal Scientist, Analytical Sciences

About the role

At Orna Therapeutics, we are seeking an exceptional Principal Scientist, Analytical Sciences to join our Analytical Sciences team. The ideal candidate will implement Orna's analytical testing strategy for circular RNA and lipid nanoparticle formulations with a focus on chromatography methods. They will develop and qualify drug substance and drug product analytical methods and perform characterization studies. Additionally, they will build and develop internal analytical capabilities to support in-process, release, stability, and characterization testing of drug products.

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.

Basic 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.

Additional Preferences

• IP-RP, SEC, and AEX are particularly valued.
• Knowledge of additional analytical methodologies such as LC-MS, DLS, CE, and/or Spectrophotometry and regulatory requirements is a plus.
• Experience with LNPs and/or mRNA is highly desirable.
• Strong oral and written skills and the ability to work independently with minimal support.