Scientific Associate
CurrentManaging analytical activities of several project (DS/DP) from early stage to release on the market:· Conduct GMP-compliant stability studies and assigned preliminary shelf-life for drug products.· Conduct of investigation derived from OOS/OOE/OOT taking in account GMP guidelines.· Development, optimization, and validation of analytical methods with a pragmatic strategy.· DS characterization and re-test.· Writing and reviewing of analytical methods, protocols, reports, CoA, and internal guidance and specification.· Interpretation and processing of analytical data, with presentation of results to interdisciplinary teams for collaborative decision-making.