Srini Bandi, Ph.D., M.B.A

Dr. Srinivasulu (Srini) Bandi is a biopharmaceutical process development, CMC and manufacturing consultant with over 20 years of experience supporting Phase 1/2/3 development and BLA-ready manufacturing. He specializes in process development, process characterization, scale-up, technology transfer, and PPQ for biologics, nucleic acids, and high potency small molecules across microbial and mammalian platforms. Srini provides strategic leadership in CDMO selection, vendor qualification, and external manufacturing oversight, and partners closely with Quality and Regulatory teams to deliver inspection-ready, compliant CMC packages. He helps late-stage programs de-risk development, control costs, and achieve commercial readiness. Prior to joining Pharmefex, Srini held roles as Director of process development and external manufacturing at Sail Biomedicines, a clinical stage biotech company developing circular RNA based LNP-Antibody conjugates for autoimmune diseases. Prior to joining Sail Biomedicines, Srini worked as consultant and contractor roles with biotech companies developing processes, tech transfers and clinical manufacturing of pDNA, antibody and microbiome products.  He also worked in BioVectra, a CDMO for 11 years at various levels primarily led the tech transfers, process development, scale-up & clinical manufacturing and supported process validation & commercial manufacturing activities. He holds a Ph.D. in Pharmaceutical Biotechnology from Andhra University, India and Executive MBA from UPEI, Canada. He also trained as a postdoctoral researcher from KAIST, South Korea and NRC, Canada.