Coordinate with global R&D sites to provide end-to-end support for stability testing in partnership with local and global analytical and product development teams.
Perform testing and report results for routine analysis and new product formats using analytical instrumentation in a cGMP environment.
Develop, optimize, and validate analytical methods; apply troubleshooting to analytical instrumentation; and lead the transfer of analytical methods and new technologies.
Drive operational excellence initiatives to simplify and improve technical processes, including utilizing statistical approaches to experimental design.
Maintain, calibrate, qualify, and troubleshoot instrumentation, while maintaining accurate, up-to-date, and concise laboratory records and practicing good documentation practices (ALCOA+ principles).
Qualification & Experience
Education: M.Sc (Analytical Science, Organic Chemistry or similar) or Masters in Pharmacy.
Experience: Minimum 2 years of total experience, with a minimum of 1 year of direct, hands-on experience with HPLC/GC in a cGMP environment.
Strong knowledge and expertise in chromatography (HPLC/GC) and working as an analytical scientist with a multinational pharma/FMCG organization, particularly with experience in stability testing.
Thorough knowledge of ICH/WHO/FDA guidelines, cGMP requirements, ALCOA+ principles, and stability testing.