Research Scientist

Responsibilities

• Identify unknown impurities and degradation products using HRMS and MS/MS using manual spectral interpretation, deconvolution
• Perform fragmentation interpretation and structural elucidation.
• Correlate orthogonal analytical data for impurity assignment.
• Prepare scientific justification for impurity structures.
• Support root cause investigations related to product quality issues.
• Data Analysis using different software / tools, data trending and statistical evaluation
• Aggregation & Higher Order Characterization Support
• Optimize chromatographic separation for complex biomolecules.
• Develop fit-for-purpose characterization workflows.
• Participate in method qualification, transfer, verification, and validation.
• Troubleshoot analytical methods and instrumentation
• Prepare technical reports and characterization summaries.
• Author SOPs, analytical procedures, protocols, and scientific reports.
• Support regulatory submissions (IND, NDA, BLA, ANDA, DMF, CTD Module 3) and provide scientific responses to the queries.
• Maintain laboratory documentation in accordance with quality systems.
• Cross-functional Collaboration and driving analytical activities throughout product development and lifecycle management
• Drive continuous improvement initiatives and implement new analytical technologies.
• Participate in scientific discussions, troubleshooting, and project planning.
• Ensure compliance with GMP, GLP, ALCOA+, and Data Integrity requirements and safety in the lab.