Abhinaya Thummala

About Abhinaya Thummala

Senior operations leader in the field of biopharmaceuticals with a proven track record of delivering drug and combination products and solutions for commercialization and lifecycle management. Global operations leader for Tezepelumab, responsible for the product\'s development, manufacturing, CMC regulatory & launch strategy & execution, product quality & supply risk management, delivering operations’ insights for the product\'s clinical and commercial strategy, business case development, business optimization, and partnership/alliance management.Drug product team lead for Amgen’s first electromechanical device, the Neulasta On-body Injector (OBI); Experienced in combination product development, qualification, filing and launch.Drug product team lead for multiple commercial and pipeline products including Biosimilars; responsible for all DP operations including formulation and final presentation development, aseptic DP process design, technology transfer for validation, commercial process monitoring and CMC deliverables.

Experience

1. Executive Director

   Amgen

   Jan 2023 — Present · Thousand Oaks, CA, US

Education

• University of Oklahoma

  Master’s Degree, Chemical Engineering

  2001 — 2003

Skills

• Pharmaceutical Industry
• Fda
• Regulatory Submissions
• Combination Products
• Pharmaceutical Process Development
• Validation
• Design Verification Testing
• Ich Guidelines
• Biotechnology
• Process Engineering
• Gmp
• Cross-Functional Team Leadership
• Biotherapeutics
• Drug Product Fill Finish
• Project Management
• Process Design
• Change Management
• Manufacturing
• Medical Devices
• Product Development
• Technology Transfer
• Biopharmaceuticals
• Process Monitoring
• Process Improvement
• Formulation