Greater Bengaluru Area
25 years of Biologics operations experience. Managed many Biopharmaceutical products manufacturing, scale-up, technology transfer in CDMO and commercial manufacturing setup. Played a big role in EMA and USFDA inspections. Built and operated 3 cost effective Biologics (Single use, hybrid and SS) manufacturing facilities with state-of-the-art design and global compliance standards. My core specialties in Biologics: DS Manufacturing and fill finish - Biosimilar mAbs, novel mAbs and ADCs Facility design, Commissioning & Qualification Creating business and implementation cases P&Lmanagement Business strategy People management
Leading Scale-up and GMP manufacturing (contract) operations for the Mabs and various key Biosimilar proteins ( An EU GMP certified facility of Syngene Biologics ). worked on multiple 2 KL single use platform based operations for manufacturing of mAbs. Established scale-up and technology transfer cell culture process. Played a key role in EU-GMP and USFDA approval for the Biologics manufacturing plants. Business case development and building cost effective manufacturing plant and labs to support the Biologics business expansion. Client engagement and collaboration. Team building and talent management.
Mammalian and microbial manufacturing operations.
Worked on the Biosimilar Mabs and glycoproteins (cell culture -USP) process development and process optimization. Worked on micro carrier based viral vaccine development (Bio safety level -3). Introduced and used disposable Biotreactor technology (SUB) for the process development. Worked on Tox requirements and facilitated the Tox material.