Vacancy Description
The Analytical Development Scientist will be responsible for leading the development, validation, and transfer of analytical methods to ensure the quality, robustnessn and regulatory compliance of pharmaceutical products throughout their lifecycle.
This role acts as a key analytical reference within cross-functional project teams, supporting product development from early stages through GMP manufacturing and regulatory submission.
Responsibilities
- Leadthedevelopmentandoptimizationofanalyticalmethods,primarilyusingchromatographictechniques(HPLC, UPLC),providingtechnicalguidanceandsupporttoanalyticalteams.
- ValidateanalyticalmethodsincompliancewithICHguidelines(Q2(R2), Q14).
- Manage and support analytical method transfers to internal and external laboratoris, including deviation investigation and resolution.
- Coordinateandmanagestabilitystudies,ensuringappropriateplanning,execution, dataevaluation, anddocumentation.
- Perfo...
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