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About the Role
Company: Listed pharma company having API, Peptides, Formulation and Biologics business.
Department: Analytical Research and Development for Active Pharmaceutical Ingredient(API)
Position : Manager - AR&D/ADL
Experience: 12-15 Y in HPLC Method development
Job description:
- To develop HPLC / UPLC methods for related substances/ assay/ Recation monitoring/ non-carryover/ genotoxic impurities in APIs as per ICH Q2 requirements.
- To conduct forced degrdataion studies and evaluate mass balance
- To evalute LC MS data to identify degradation products
- To qualify reference and working standards
- To conduct Analytical method transfer to the manufacturing sites
- To respond Regulatory deficiences and Quality control related issues
- To troubleshoot HPLC / UPLC instruments and ...
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