Sumit Dutta

Background

About Sumit Dutta

Driving Biopharma Innovations To Market With Quality & Speed: Process Development & CMC leader with 12+ years of experience in global development, GMP manufacturing, & life cycle management of biologics–enabling revenue creation of over US$ 500M. Core competencies include: Process Development, GMP manufacturing: Early to late-stage clinical development. Mammalian cell culture, process optimization & characterization, QbD, DOE. Scale up, technology transfer, process validation (PPQ), risk assessments, investigations. Developing & executing CMC plans, managing phase-appropriate activities, authoring CMC sections. Products: vaccines, mAbs, fusion proteins, devices. Cell lines: CHOs, MDCK, Fibroblasts Cross-functional leadership: Influencing leaders & peers, understanding & addressing stakeholder needs, change management. Synthesizing & presenting data to executives, leaders, & peers–to drive technical & business decisions. People leadership (5 years): Leading teams, empowering talent, hiring, mentorship Outsourcing: CDMO site selection. Process development & GMP manufacturing using external partners Regulatory Affairs: Collaborating with FDA on submissions, meetings, audits. ICH, FDA, ISO, USP guidelines