Sandeep Kongara

Associate Director - External Manufacturing Precision BioSciences

Senior biopharmaceutical operations leader with 20+ years of experience leading global external manufacturing networks across clinical and commercial supply. Proven track record in CMO/CDMO oversight, production planning, materials management, quality systems, and technology transfer. Experienced in serving as the primary operational interface for external partners, driving issue resolution, governance, and continuous improvement to ensure reliable, compliant, and cost-effective supply. Strong cross-functional leader with expertise spanning CMC, Quality, Supply Chain, Finance, and Procurement

Seminars

Thursday 1st October 2026
Designing Resilient CDMO & Supply Chain Partnerships to Enable Rapid Scale-Up from Clinical to Pivotal for mRNA–LNP Therapies
9:00 am
  • Moving beyond single-CDMO reliance by building flexible partnership models, including balancing primary and backup manufacturers without overextending budget or timelines. Driving early alignment with CDMOs on process characterization, PPQ strategy, batch sizing, and scale-up assumptions to minimize revalidation risk and accelerate pivotal readiness
  • Strengthening supply chain resilience, including strategies for critical raw materials such as lipids and key components
  • Establishing effective governance models to enable faster decision-making and seamless execution across partners
Sandeep Kongara speaker for 5th mRNA Process Development & CMC Summit