Aruna Gorusupudi

About Aruna Gorusupudi

I am a bioanalytical and pharmacokinetics scientist specializing in pre‑clinical pharmacology, biochemistry, and PK. I serve as the primary point of contact for bioanalytical method development and validation across Clinical and ADME studies, building robust LC‑MS/MS (triple quad) and GC‑MS methods aligned to ICH guidelines for small molecules and new chemical entities.I plan and lead studies end‑to‑end—from experimental design through execution—then integrate, analyze, interpret, and report data to drive program decisions. My hands‑on expertise spans absorption kinetics, half‑life and AUC analysis (Phoenix WinNonlin), drug toxicology, compound stability in formulations, and metabolite assessment, ensuring data quality and translational relevance.As a people leader, I manage, mentor, and develop scientists while fostering clarity in goals and growth plans. I’m highly collaborative, partnering closely with ideation teams, medicinal chemistry, formulations, clinical pharmacology, and regulatory to design promising therapeutic candidates. I’ve contributed to non‑clinical summaries for IND applications and NDA filings, delivering comprehensive, accurate documentation that supports regulatory success.Core strengths: Bioanalytical method development & validation • LC‑MS/MS (triple quad) • GC‑MS • Pharmacokinetics (half‑life, AUC) • Phoenix WinNonlin • Toxicology • Stability & metabolite profiling • ICH compliance • Cross‑functional leadership • Data storytelling & decision support • Team building & mentoring

Experience

1. Senior Scientist

   Alcon

   Sep 2021 — Present · Durham, NC, US

   With over a decade of experience in traslational LC-MS based bioanalysis, I have focussed on driving scientific excellence and operational efficiency in Pharmaceutical environment. My background spans small molecule bio-analysis, method development and GxP validation. My expertise extends across both targetted and non-targetted mass spectrometry using LC-MS/MS and GC-MS/MS, Data processing, pharamacokentic Anlaysis and Pk/PD modelling, supporting IND enabling studies and NDA supporting studies. Profile: 1. 10 years of experience in mass spectrometry based small molecule anlasysis with a special focus on biologics. Proficient in assay development, automated extraction methods for small molecules, conjugated molecules, drug-drug combination and device-drug comabinations for microscopic ocular tissues. Experienced in operating and maintianing Waters Aquity Xevo, Thermofisher Orbitrap, Sciex Triple Quad LC-MS sysytems with MassLynx, Mass Hunter and Chromoleon software. Skilled in analytical data processing, pharmacokinetic profiling using WinNonLin and PK/PD modeling to support non-clinical and clinical bioanalytical studies. Author Veeva reports and non-clinical pharmacology sections for IND enabling studies and NDA submissions.6. Knowledge of GxP regulatory requirements

Education

• GITAM college, Andhra University

  Masters in Science, Biotechnology

  2003 — 2005

• Andhra University

  Bachelor's degree; Dr. V.S. Krishna Govt, Chemistry; Botany and Biotechnology

  2001 — 2003

• Central Food Technological Research Institute (CFTRI), Mysore

  Ph.D, Biochemistry and Nutrition

  2007 — 2012

• Andhra University

  Master of Science, Biotechnology

• Central Food Technological Research Institute, Cheluvambe Mansion, Mysore.

  Doctor of Philosophy, Biochemistry

• Andhra University

  Bachelor of Science, Biotechnology

Skills

• Lc-Ms Characterisation of Molecules
• Research
• Immunology
• Cell Biology
• Elisa
• Molecular Biology
• Biochemistry
• Genomics
• Gc-Ms Analysis of Fatty Acids
• Hplc
• Western Blotting
• Hplc Analysis
• Microbiology
• Genetics
• Life Sciences
• Qpcr
• Cell Culture