Shomit Mansur, PhD
QC Chemist II @ AmbioPharm - A Global Peptide CDMO
About
Analytical Scientist with over 5 years of experience developing, qualifying, and validating analytical methods for small- and large-molecule drug candidates. Proven competence in HPLC, LC-MS/MS, GC, UV-Vis, and dissolving procedures that comply with ICH, FDA, and USP regulatory frameworks. Hands-on involvement in drug discovery and development life cycles from preclinical to late-stage, with a strong emphasis on experimental design, data analysis, and regulatory documentation. Capable of tackling complicated analytical challenges and working cross-functionally with R&D, QC, and regulatory teams.
United States
Augusta
Nanotechnology
Method Transfer, ELISA, Flow Cytometry, Immunofluorescence, Cell Based Assays, Technical Documentation, Analytical Method Validation, Analytical Chemistry, cGMP practices, Communication, Method Development, Scanning Electron Microscopy (SEM), Optical Microscopy, FTIR, Confocal Microscopy, Spectroscopy, Nanomedicine, Laboratory Skills, Targeted Drug Delivery, SDS-PAGE
Experience

QC/R&D Chemist
Winder Laboratories LLC
Winder, Georgia, United States
Led analytical method development and validation for assay, dissolution, and impurity testing for generic drugs and APIs, reducing development timelines by 20%. Designed and optimized sample preparation protocols (SPE, LLE, hydrolysis, magnetic bead separation), improving recovery rates by 35% and enhancing sensitivity of low-dose formulations. Contributed to successful batch release and stability testing by performing routine QC under strict cGMP, GLP, and USP standards. Authored and executed SOPs and validation reports; supported regulatory documentation for internal audits and external agency inspections. Performed instrument troubleshooting, maintenance, and calibration (LC-MS, GC-MS, UPLC, FTIR), reducing lab downtime by 40%. Collaborated with R&D and QC teams to support seamless method transfer, ensuring operational readiness for scale-up.

Graduate Research Assistant
Alabama, United States
Designed and executed research projects on nanoparticle-based drug discovery platforms; secured 50K in research funding. Developed and optimized LC-MS protocols to characterize proteins and small-molecules; validated analytical performance metrics. Performed analytical method development using RP-HPLC, SEC, and IEX to resolve and analyze complex biomolecular formulations. Conducted ELISA and Western blot to assess protein expression; performed nanoparticle uptake tracking via confocal microscopy to validate targeted release. Published two first-author peer-reviewed articles, wrote technical reports, and presented results at national and international scientific conferences. Mentored 5+ researchers in nanoparticle characterization, cell sorting, data representation, and instrument troubleshooting.
Education

Chemical Engineering
Dissertation Topic "Developing a novel drug screening nanoplatform to detect potential drug leads from complex matrices" Researched to establish a uniform synthesis method to prepare our magnetic drug screening nanoplatform of desired size, shape, uniformity and surface chemistry. Prepared protocols for cell culture and isolate cell membranes and then encapsulate nanoparticles to develop drug screening nanoplatform with immobilized transmembrane receptors on surface. Executed a conventional magnetic ligand fishing drug screening approach to identify selective transmembrane receptor binders and identify their anticancer effects via in vitro cell based assays.
Shomit Mansur, PhD's Contact Information
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