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• Lead phase-appropriate analytical development strategies for various therapeutic modalities (mAb, Bio-similar, Fc-fusion, bifunctional mAb, Glycoprotein, vaccines, mRNA- LNP, ADC and Peptides), drug substance, and drug product across the product lifecycle.
• Complete in-depth characterization (including bio-physical characterization, aggregation, particulates and MS based PTMs) of protein, ADC and mRNA-LNP therapeutics.
• Design QbD based on CQA, oversee, and execute analytical method development, qualification, and validation to support very early developmental stage through late-stage (Phase 3/BLA and commercialization) programs.
• Design analytical development methods for process characterization based on pCQAs.
• Analytical lead for numerous DS, DP projects for biologics including ADC and mRNA-LNP in preclinical through commercialization.
• Subject matter expert in analytical characterization, release, stability, and designing comparability for biologics, ADCs and mRNA-LNP.
• Working as Analytical lead in various projects in CDMO, an unique experience is established such as engagements with clients, handling molecules in various phases, phase appropriate analytical method development, scientific oversight of method development, validation, transfer, routine testing activities and assisting clients in authoring, reviewing, and contributing analytical content to CMC sections of regulatory submissions (INDs, IMPDs, BLAs, MAAs).
• Collaborated with cross-functional teams to achieve project milestones.
• Hands-on instrumentation experience: HPLC & UPLC (AEX, CEX, RP, NP, SEC, HIC, HILIC, IP-RP, affinity), CE (cIEF, iCE, CE-LIF), Caliper’s Labchip, FT-IR and UV-Vis, SDS- PAGE and ELISA, QExactive Plus, LTQ Orbitrap XL, LTQ, Triple Quadrupole (Qtrap 4000), MALDI TOF MS, microTOF, SEC-MALS and FFF (Eclipse)-MALS, CD, DCS, LS and particle analysis (NanoSight and Mastersizer), GC-MS, GC, GPC

*Catalent acquired Cook Pharmica in 2017 and Novo Nordisk acquired Catalent in 2025. I joined Cook Pharmica as Scientist in 2010

• Designed and executed innovative research experiments in molecular biology.
• Developed and optimized laboratory protocols to enhance efficiency and reproducibility of results.
• Primarily worked in Mass-Spectrometry based proteomics, glycoproteomics and glycomics. Extensively involved in glycan profiling, identifying glycosylation sites in proteins, ID of PTMs, protein-expression profiling seeking to discover and identify differentially expressed proteins associated with various diseases.