Lalit Kumar

Audit Achievement: Successfully defended analytical data during US FDA Regulatory Audits, ensuring zero observations. Method Development: Conceptualized, validated, and executed complex method transfers for NDSRIs and genotoxic impurities using LC-MS/MS and GC-MS/MS systems. Orbitrap HR-MS: Expert in Data-Dependent MS2 (ddMS2), Targeted Selected Ion Monitoring (t-SIM), Parallel Reaction Monitoring (pMRM), and All-Ion Fragmentation (AIF) acquisition modes on Thermo Scientific Orbitrap.

Audit Achievement: Core technical team member during EMA and TGA audits, validating analytical standards and method compliance. Trace Analysis: Developed and validated high-sensitivity methods for NDSRIs and genotoxic impurities using LC-MS/ MS and GC-MS/MS on Agilent Mass Hunter. HR-MS Characterization: Operated HR-MS Orbitrap systems executing ddMS2, t-SIM, pMRM, and AIF data acquisition workflows via Xcalibur and Freestyle.

Audit Achievement: Successfully faced US FDA Audits for elemental impurity testing lines, demonstrating flawless data traceability and adherence to validation protocols. Elemental Impurities: Formulated, validated, and transferred analytical methods for ICH Q3D elemental impurity testing using ICP-MS (Mass Hunter). Documentation: Authored and verified critical analytical documentation including method validation protocols, SOPs, and technical transfer reports.