Dr. Prasad Shetti PhD PMP

Integration project: Executed 40 Market authorization transfer in period of 8 month, without impacting business continuity. (Merck to P&G)

-Governance and process: Set up the PM process (Gate process) for the project in Technical operations. Streamline project as per the process. -Leadership on the project: Successfully launched 5 projects worth 70 Mio € in last 3 years. -Portfolio analysis: Prepared portfolio analysis to support developing strategies to reduce operational complexity by 10%. -Optimizing Supply Chain Process: Setup simplified and agile artwork process increasing the work efficiency by 20% (Agile process development).

1) Leadership on the project: Leading multi functional team members from CRO, Legal Dept., Marketing/Branding team, Regulatory Affairs, QA, Medical Mgmt, SNO team, CMO, Technical, Procurement etc. Managing project budget planning, timelines, assessments (risk , regulatory, technical, medical, quality) 2) Ownership on product development: Coordinating with multi functional team members for getting prototyping done,project presentation in governance meetings, End to end project management.

1) Team leader in Global product development stability cell (5 direct reports) 2) Handling Project independently to develop and validate the analytical method, as well as perform the study such as proof of concept (POC), Pre-formulation study, Technology transfer to site etc. 3) Successful tech transfer across the world. 5) Working in the USFDA compliant Lab. Preparation of c-GMP documentation. Facing USFDA audits. 6) Lab digitalization to reduce human error.

1) Work on analytical method development and Validation of Analytical method as per ICH guidelines. 2) Isolation of impurity on Preparative HPLC and its characterizations, 3) Work for a Technology Transfer for Analytical Method from R&D to Plant. 4) Preparation of c-GMP documentation as per ICH guidelines and pharmacopeias. 5) Routine work allotment and Planning for additional personnel (3 Junior Scientist)

Thesis on "Study on development of LC-MS method for some antipsychotic drugs from formulation and biological fluids.”

Analytical Chemistry

Chemistry