Manager - Analytical R&D(API)

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 ...