Viswa N

Accomplished Scientist with a strong interdisciplinary foundation in analytical chemistry, protein biochemistry, and molecular biology, with experience spanning research, pharmaceutical, and biotechnology environments. Skilled in method development and validation for impurity profiling including nitrosamines using LC-HRMS, HPLC, and GC-MS in GMP-compliant laboratories, following compendial standards such as USP, EP, and regulatory expectations under ICH guidelines. Proficient in recombinant protein expression across bacterial, yeast, and mammalian systems, complemented by expertise in advanced purification techniques including SEC, IEC, and HIC.

Experienced in biophysical and analytical characterization methods such as LC-HRMS, SEC-MALS, DLS, NMR, and ELISA, with a proven ability to support cross-functional development of therapeutic proteins and peptides. Dedicated to scientific excellence, data integrity, and regulatory compliance while delivering effective, innovative solutions to complex challenges in drug development.

Analytical R&D Scientist at Quagen pharmaceuticals (2025-12 – Present)

• Designed and executed analytical method development studies by optimizing chromatographic conditions, sample preparation, and detection parameters to improve method robustness, sensitivity, and reproducibility for pharmaceutical drug substances and drug products in a cGMP environment.
• Authored Method Validation Protocols (MVPs), Method Validation Reports (MVRs), Method Development Reports (MDRs), analytical procedures, and SOPs to support regulatory submissions and lifecycle management.
• Performed forced degradation studies, impurity profiling, degradation pathway investigations, and structural elucidation of unknown impurities using high-resolution mass spectrometry and chromatographic techniques.
• Led analytical method validation and verification activities by evaluating accuracy, precision, specificity, linearity, robustness, detection limits, and quantitation limits in compliance with ICH and cGMP requirements.
• Supported analytical method transfer to Quality Control laboratories by preparing transfer protocols, providing technical oversight, resolving transfer-related issues, and ensuring successful implementation.
• Investigated atypical analytical results, OOS/OOT events, and method performance issues through scientific root cause analysis, recommending corrective actions to improve method reliability.
• Collaborated with Formulation Development, Process Development, Quality Assurance, Regulatory Affairs, and Manufacturing teams to provide analytical support throughout product development, technology transfer, and regulatory filing activities.
• Utilized advanced analytical instrumentation including LC-HRMS, HPLC, RP-HPLC (Empower), GC-MS, FTIR, UV-Vis, SEC and Ion Chromatography for comprehensive characterization of pharmaceutical materials.
• Maintained complete analytical documentation, laboratory notebooks, validation records, and technical reports in compliance with cGMP, ALCOA+, data integrity principles, and regulatory expectations.
• Collaborated cross-functionally with formulation, Quality Control (QC), and Quality Assurance (QA) teams to support drug development, regulatory submissions, and inspection readiness.

Senior Scientist at Stira Pharmaceuticals (2025-04 – 2025-12)

• Performed analytical testing of raw materials, in-process samples, intermediates, and finished products in compliance with cGMP, GLP, USP, and regulatory requirements.
• Developed, optimized, and validated analytical methods for assay, related substances, residual solvents, dissolution, and trace-level nitrosamine analysis using LC-HRMS, HPLC, UPLC and GC-MS.
• Conducted impurity profiling, stability studies, degradation assessments, and structural elucidation of unknown compounds using high-resolution mass spectrometry and chromatographic techniques.
• Operated, calibrated, and troubleshot analytical instrumentation including LC-HRMS, HPLC (Empower), GC-MS, FTIR, Ion Chromatography, DSC, TGA, UV-Vis, and related laboratory equipment.
• Investigated deviations, OOS/OOT results, and analytical issues through root cause analysis, supporting CAPAs and ensuring compliance with ALCOA+, GDP, and data integrity principles.
• Reviewed analytical data, interpreted complex chromatographic and mass spectral results, and prepared Certificates of Analysis (COAs) and technical reports.
• Collaborated with QA, Manufacturing, Regulatory, and R&D teams to support method transfers, analytical troubleshooting, process improvements, and regulatory inspection readiness.
• Maintained GMP-compliant laboratory documentation, calibration records, validation protocols, and SOPs while contributing to continuous quality and laboratory efficiency initiatives.

Analytical Chemist at Aavis Pharmaceutical (2024-01 – 2025-04)

• Performed GMP-compliant quality control testing of APIs, raw materials, in-process materials, and finished drug products using HPLC/UHPLC (Empower, Chromeleon), UV-Vis, ICP-MS, Gamma Spectroscopy, and compendial analytical methods.
• Executed release, stability, and in-process testing to evaluate identity, potency, purity, and impurity profiles, supporting timely product disposition and batch release.
• Supported analytical method validation, verification, qualification, and transfer activities to ensure successful implementation of test methods within GMP QC laboratories.
• Investigated analytical deviations, OOS/OOT results, and instrumentation issues through systematic troubleshooting and root cause analysis, contributing to CAPA execution and regulatory compliance.
• Performed installation, calibration, IQ/OQ/PQ qualification, preventive maintenance, and performance verification of analytical instrumentation to ensure data reliability and laboratory readiness.
• Maintained GMP-compliant documentation, electronic laboratory records, and data integrity in accordance with ALCOA+, GDP, and 21 CFR Part 11 requirements.
• Collaborated with QA, Manufacturing, and CMC teams to support batch release, laboratory investigations, audit readiness, and continuous process improvements while adhering to cGMP, USP, EP, and ICH guidelines.

Research Associate at Oklahoma State University (2019-08 – 2024-01)

• Designed and executed molecular cloning strategies, expression construct optimization, and recombinant protein production in both mammalian (CHO, HEK293) and bacterial (E. coli) expression systems.
• Developed and optimized purification workflows using RP-HPLC, ion-exchange chromatography, size-exclusion chromatography, and affinity techniques such as Ni-NTA to achieve high-quality protein preparations.
• Performed comprehensive analytical characterization of purified proteins utilizing LC-MS, SEC-MALS, CE-SDS, ELISA, and SDS-PAGE to assess identity, purity, and structural attributes.
• Utilized biophysical techniques—including circular dichroism, isothermal titration calorimetry, dynamic light scattering, and multidimensional NMR—to evaluate protein stability, ligand interactions, and aggregation profiles.
• Maintained thorough and compliant documentation of experimental procedures, adhering to GLP practices, established SOPs, and data integrity expectations.
• Collaborated with cross-functional teams to analyse datasets, interpret complex results, and present scientific findings at internal meetings and research forums.
• Led and instructed General Chemistry and Organic Chemistry laboratory sessions, ensuring safe laboratory practices, proper technique, and student comprehension.
• Oversaw laboratory equipment setup, reagent preparation, and operational management.

Ph.D. in Chemistry – Oklahoma State University

M.Sc. in Chemistry – Vellore Institute of Technology Osmania University

B.Sc. in Chemistry, Microbiology, Genetics – Osmania University