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 recent 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.

📌 Research Scientist Hyderabad
🏢 Laurus Labs
📍 Hyderabad