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
- Building partnership models that go beyond single-CDMO reliance, including how to
- qualify and balance primary and backup manufacturers without overextending budget or timelines
- Aligning early with CDMOs on process characterisation, PPQ strategy, batch sizing and scale-up assumptions to avoid revalidation risks and ensure readiness for rapid progression into pivotal studies
- Integrating supply chain and licensing considerations into partnership strategy, including critical raw materials, IP constraints and long-term commercial implications that are often locked in earlier than anticipated