Dillip Kumar Jena

Background

About Dillip Kumar Jena

SPECIALITIES: •PARA-IV/ FTF projects/ Early Identified Products •Modified Oral Drug Delivery •Multiparticulate oral controlled drug delivery systems. •Delayed release tablet /multiparticulates/ Minitablets •Special expertise in handling of complex Azole molecules and highly variable complex molecules •Special expertise in the area of Enteric coating/ Extended release coating using Wurster process. •Special expertise in the area of powder layering technology(By using Granurex GX20/85 and CCG) •Strategy formation and full kitting of project including availability of required regulatory licenses, necessary approvals, raw materials and costing of projects before introduction of the project for its nonstop progress leading to timely filing •Responsible for implementation of QbD (Quality by Design) based formulation/ process development using Design of experiments (DOE) • Facilitate smooth movement of project through phase gate at different stages from development to till filing. •Introducing the project plan and effectively tracking with the use of CCPM Principles in Concerto. •Regular focus on projects, planning and periodic updating to regional delivery function heads •Directing, leading & motivating workforce and imparting continuous technical/on job training for accomplishing greater operational effectiveness/ efficiency •In-vitro, in-vivo pharmacokinetic data interpretation and finding out discriminatory dissolution media to drive the formulation development and optimization. •Preparation of response for the regulatory queries /FDA deficiencies for submitted ANDAs. •Leading a team of 10 to 12 member of both formulation and analytical scientist to ensure end to end delivery of multiple highly complex projects with the initiating of robust product development, optimization, scale up & technology transfer of Oral Solid Dosage forms (IR/DR/ER) for NDA/ANDA/EDF filings in US market