Analytical Scientist

Dr. Reddy's · India

About this role

Role Overview: You will be working as an Analytical Specialist specializing in Mass Spectrometry at Dr. Reddy's Laboratories Ltd. Your main responsibility will be to develop sensitive and robust methods for quantifying genotoxic impurities in drug substances and products. Your expertise in Mass Spectrometry will be crucial in creating accurate impurity profiles through comprehensive analysis. Key Responsibilities: - Develop sensitive and robust methods to quantify genotoxic impurities in drug substances and products. This includes selecting appropriate quantitation modes, validating methods, transferring them to QC sites, troubleshooting, and resolving method-related issues. - Identify impurities in stress and stability studies, correlate data based on Mass and fragmentation, and develop methods for screening leachables in Parental formulations to create accurate impurity profiles through comprehensive analysis. - Respond to regulatory deficiencies related to Mass spec techniques, provide quantitation support for plant samples, perform structure confirmation activities for working/reference standards and impurities, and propose relevant measures for timely responses to potential queries from regulatory authorities/customers. - Train new team members, prepare Standard Operating Procedures (SOPs) and guidelines, conduct incident/investigation analysis, identify Corrective Action Preventive Action (CAPA) and root causes, ensure adherence to safe work practices, maintain Good Man