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Profile Details

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USD 200 /hr

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Hire Dr. Nitesh D.

India

USD 200 /hr

An experienced Biopharma professional in business of Biopharmaceutical product Development in US, EU and Emerging mkt

Profile Summary

I am an experienced Biopharma program director in business of Biopharmaceutical products. I have grown up the value chain by living through the experience of development of Biologicals. I have lived through the journey of development all the way from bench level researcher in process development leading into guiding a group of cross functional leaders. In this journey, I have gained valuable experience through leading cross functional teams in areas of Research and Development, Operations, Quality, regulatory, Intellectual property, project and program management, Business development and finance. The team developed and managed entire value chain of product development. I managed P&L of the various program related cost and risk management. I have successfully led the teams to approval of products in various emerging markets.  I successfully led team to apply MAA in Japan leading to approval. The team has been awarded several times for the efforts.  In addition I have also learnt the art of product development in various areas of techno-commercial space, program and alliance management. I have had experience with different regulatory agencies like EMA, FDA, PMDA, MHRA, MPA, BfrAM and PMDA in filing, meetings as well as regulatory advice. I have also been instrumental in various due diligence in-licensing and out licensing of products and have successful alliance with partners. I have received several individual and team awards during my career.

Subject Matter Expertise

Services

Research
Consulting
Data & AI
Product Development

Research Market Research, User Research, Meta-Research, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Big Data Analytics

Product Development Formulation, Product Evaluation, Product Validation, Manufacturing

Work Experience

BioPharma Strategy Consultant

Freelance Consultant

November 2017 - Present

Vice President, Product Development

Stelis Biopharma

April 2017 - October 2017

Various leadership roles

Biocon Biologics

June 2001 - March 2017

Education

PhD

School Of Bioseparation

April 2009 - July 2013

MS Biotechnology

University of Pune, India

June 1992 - August 1994

BS Biochemistry

St Xavier's College

June 1989 - July 1992

Certifications

Credible Leadership Change Agent

Biotechnology
https://www.gwu.edu/
January 2011 - Present