Sudhir Verma

Biography

Sr. Scientist/Group Leader Company Name Takeda Oncology Dates Employed Jan 2015 – Present Employment Duration 2 yrs 9 mos Location Cambridge, MA Lead NCE’s drug product development: Phase 1 up to registration batches. Represent formulation department on cross-functional CMC teams and provide scientific/technical leadership on formulation/process development and scale up. Coordinate project activities with other internal functions including analytical, CDL, QC, QA, regulatory, clinical supply, finance, legal and operations. Develop product development plans, budgets and timelines aligned with clinical goals. Manage CMOs activities encompassing CTM manufacturing, formulation development, process optimization, tech transfer, investigations, change control and CAPA’s. Author/review technical reports and CMC sections of regulatory dossiers. Contribute to due diligence related to formulation aspects Supervise and guide junior level scientists.

Research Interest

Pediatrics