Jitendra Mishra

Founder at CelAxle Bio

Speaker

Jitendra Mishra is the Founder of CelAxle Bio, a precision biomanufacturing startup based in Pune, India. He brings over 12 years of U.S. biopharma experience across advanced modalities, including viral vectors (AAV, adenovirus, HSV) and mRNA-LNP platforms, with roles at Thermo Fisher Scientific and Moderna
Over his career, he has led analytical development efforts supporting programs from early development through late-stage clinical readiness, overseeing assay development, validation strategy, stability programs, and GMP release frameworks. He has contributed to FDA-facing CMC discussions and regulatory documentation, guiding analytical strategy through critical phase transitions where data quality and control strategy directly influence regulatory confidence.
At CelAxle Bio, he now focuses on building manufacturability-driven biotech platforms and advancing lifecycle-oriented analytical thinking within India’s evolving biomanufacturing ecosystem.