Analytical Scientist

Job Summary

• You will be responsible for developing sensitive and robust methods to quantify genotoxic impurities in drug substance and products. This involves selecting appropriate quantitation modes, validating methods, and transferring them to QC sites. Your role includes troubleshooting and resolving method-related queries and issues, ensuring quality robust method development.
• You will be responsible for identifying impurities in stress and stability studies, correlating data based on Mass and fragmentation, and developing methods for screening leachables in Parental formulations. The goal is to create accurate impurity profiles through comprehensive analysis.
• You will respond to regulatory deficiencies related to Mass spec techniques, provide quantitation support for plant samples, and perform structure confirmation activities for working/reference standards and impurities. Anticipating potential queries from regulatory authorities/customers and proposing relevant measures for timely responses are crucial aspects of this role.
• You will be responsible for training new team members, preparing Standard operating procedure (SOPs) and guidelines, conducting incident/investigation analysis, identifying Corrective Action Preventive Action (CAPA) and root causes, and ensuring adherence to safe work practices. Maintaining Good Manufacturing practices (GMP) in laboratory and conducting preventive maintenance of instruments are essential for meeting minimum operating standards. 

Educational qualification:

• Able to understand the mass spectrometry principles and Liquid chromatography principles.
• Good hands-on experience on Liquid chromatography-mass spectrometry (LC_MS), Tandem mass spectrometry (MS/MS) and High resolution mass spectrometry (HR-MS) techniques.
• Excellent skill set on method development, sample preparation, matrix interference removal and validation of quantitative methods in API and formulations.
• Experience on extractable and leachable, analytical method development, validations & transfers.
• Good documentation practices and laboratory practices.
• Sound knowledge and understanding of FDA regulations governing pharmaceuticals.

Behavioral

• Excellent communication and interpersonal skills.
• Ability to work with cross functional teams.
• Strong analytical and problem-solving abilities.
• Leadership skills to motivate and mentor the team.

About the Department

Integrated Product Development Organisation

Benefits Offered