This non-laboratory role is responsible for reviewing and evaluating analytical quality data for LNP formulations and lipid materials across stability studies, method development, and investigations.  The role requires attention to detail, familiarity with GMP practices, and the ability to ensure data integrity and regulatory compliance.

• Review analytical data packages from stability studies, method development, and investigations for LNP and lipid-based products.
• Evaluate OOS/OOT investigation reports for completeness, scientific soundness, and appropriate corrective actions.
• Verify calculations, data transcriptions, and chromatographic data for accuracy and compliance.
• Ensure documentation adheres to GMP and applicable regulatory guidelines.
• Maintain review timelines and tracking logs to support release and regulatory submission deadlines.
• Partner with analytical and quality teams to resolve data disc...