Arun Bhutnar

About Arun Bhutnar

Associate Director in Analytical Development for complex Injectables.Lead analytical Scientists for Oligonucleotide and peptide injectable development. •Conduct analytical investigations for OOS/OOTs in Quality •Lead group of Impurity Identification by LC-MS •Prepare, Review and Approve Protocols for carrying out various analytical studies for raw materials and Finished product (solid orals, Injectable and Lyophilized) •Providing technical leadership and subject matter expertise relating to peptides and other small molecule related queries for various regulatory agencies •Providing subject matter expertise relating to peptide and small molecule method development related issues to develop robust analytical method. •Lead group of LC-MS for Extractables and Leachables Studies for different MOCs/CCS •Providing analytical support for Nitrosamines, NDSRI quantitation by LC-MS/MS • Leading a team of Scientists performing analytical development activities for the characterization of complex peptides and Oligonucleotide (primary, secondary, tertiary and aggregation etc ). • providing support to the lipid-based formations (Liposomal formulations) •Providing subject matter expertise relating to in-Silico toxicity assessment for toxicology group • Tech transfer, robust analytical methods, validation for commercial products, excipients, and cleaning validation as filing requirements. • Writing and reviewing the justifications for the specifications for various dosage forms. •Conducted the studies to crack critical formulation attributed like aggregation, impurities formations etc •Contributing to CMC sections of regulatory filings including ANDA and NDA submissions. •Leads or contributes to continuous improvement initiatives across the enterprise. •Partners with the Business Development group to support or lead Due Diligence evaluations •Lead the Analytical chemistry team and build oligonucleotide functions for oligonucleotides therapeutic development projects •Manage outsourced analytical activities at external contract labs •Develop drug substance specifications ensuring efficient integration across CMC and other relevant disciplines such as Clinical and Toxicology •Provide leadership, guidance, and strategic direction and planning to analytical projects of peptides and oligonucleotides in different phases. •Provide scientific leadership to the Analytical Development group in development of scientific capability and analytical strategies complex injectables •Build and maintain strong relationships with internal and external partners

Experience

1. Associate Director (Analytical Development-complex Injectable Oligonucleotide Peptide)

   Cipla

   Apr 2025 — Present

Education

• Savitribai Phule Pune University

  B.Sc

• University of Mumbai

  Doctor of Philosophy - PhD

• Savitribai Phule Pune University

  M.Sc