Vignesh Hegde

About Vignesh Hegde

Formulation & Drug Product Development Expert | Biologics & Small Molecules | Injectables | Global Regulatory StrategyAs a seasoned researcher in pharmaceutical R&D, I’ve spent the last decade and a half turning complex challenges into viable drug candidates, I specialize in injectable product development across biologics, biosimilars, and small molecules. My core expertise spans formulation development, drug product and process optimization, technology transfer, and lifecycle management for global markets including the US, EU, and ROW.I’ve successfully led cross-functional teams to design and implement cutting-edge formulation and process strategies, ensuring scientific excellence and regulatory compliance. My collaborations with global health authorities have supported product approvals and streamlined development timelines.Technical, Scientific, and Development ExpertiseI lead end-to-end formulation development for biologics, biosimilars, and small molecules, specializing in stabilization, optimization, and lyophilization. My work spans aseptic processing for vials, pre-filled syringes, and cartridges, coupled with rigorous device compatibility assessments. On the development side, I drive process scale-up and troubleshooting, oversee technology transfers from R&D to commercial manufacturing, and ensure robust process validation and GMP compliance. I also develop CMC strategy and documentation and perform IP evaluations to protect and advance product portfolios.Regulatory and Risk ManagementI navigate complex FDA and EMA requirements to prepare and submit INDs, NDAs, and BLAs under ICH guidelines. My approach integrates comprehensive risk assessment and mitigation planning throughout the product lifecycle. By harmonizing global regulatory strategy with lifecycle management, To secure approvals and maintain compliance to bring safe, high-quality therapies to market.Passionate about driving innovation and delivering high-quality solutions that improve patient outcomes, I thrive at the intersection of science, strategy, and execution.

Experience

1. Scientific Manager

   Biocon Biologics

   Apr 2024 — Present · IN

Education

• Govt School Bailure

  P.U

  1998 — 2003

• NITTE, Rajiv Gandhi University of Health Sciences

  M.Pharma, Pharmaceutical chemistry

  2004 — 2010