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
- 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