Kehinde Ikumawoyi

Analytical Scientist @Sandoz

Cambridge, GB

Design and implement stability study protocols for drug products, medical devices, or combination products.· Coordinate sample pulls and testing schedules across product shelf life.· Analyze stability data using statistical tools and prepare trend reports.· Author stability reports for regulatory submissions and internal reviews.· Ensure compliance with local and international guidelines (e.g, ICH Q1A, ISO standards).· Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs.· Support audits and inspections by providing documentation and technical expertise.· Develop and validate analytical methods for testing raw materials, intermediates, and final products.· Support formulation and process development by providing analytical insights during early and late-stage development.· Characterize product attributes using techniques such as HPLC, GC, UV-Vis, FTIR, NMR, and mass spectrometry.· Conduct stability studies and degradation profiling to assess shelf-life and product robustness.· Collaborate with cross-functional teams, including formulation scientists, process engineers, and regulatory affairs· Prepare technical documentation for regulatory submissions and internal reports.· Troubleshoot analytical issues and propose innovative solutions to improve testing efficiency.· Develop and validate analytical methods (e.g, HPLC, FTIR, UV-Vis, GC) for alternative approaches.