Vinay Gopal Nayak

Biography

Dr. Vinay Gopal Nayak, is an MSC and PhD in Chemistry. He is a pharmaceutical professional with technical background who has worked with Organisations such as Cipla, Lupin, Watson, Alembic and Emcure pharmaceuticals. He is specialised in the areas of Manufacturing, Quality, R&D, Compliance and Regulatory Affairs both for API and finished dosage form manufacturing. In a career span of 30 years he has provided leadership to the above organisations rise to become global leaders in their specialised segments.Dr. Nayak has successfully handled USFDA and other international regulatory inspections with good leadership and sound technical knowledge.In the past 10 years, he has worked in senior position of President Technical Operations at Watson, Alembic and Emcure. In these years, manufacturing operations at these organisations have been expanded exponentially. Apart from plant expansions and capacity enhancements, he has given the organisations very sound Quality systems which are capable of standing up to very tough regulatory inspections of recent years. As team player in each organisation he was capable of filing innovative ANDA and DMF products all these years through efficient Regulatory pathway.His strength/ expertise involves selecting good teams, grooming them and meeting organisational expectations all these years.The other area of expertise has been useful is to outsource key products in situations for capacity release in existing plants to make space for new approved products. He has also handled expansion projects involving designing GMP plants for finished dosage form as well as API.Dr. Nayak is a member of Indian Pharmacopoeia, Examiner of Mumbai University for Masters and Ph.D students. He is a winner of many awards and recognitions and cited in Who's Who in the world. He is also an advisory board member of USP.Dr. Vinay Gopal Nayak has joined Marksans in the capacity of Whole-time Director designated as Executive Director responsible for the entire technical Operations.Marksans now has a leader to take the organisation to the next level.

Research Interest

In the past 10 years, he has worked in senior position of President Technical Operations at Watson, Alembic and Emcure. In these years, manufacturing operations at these organisations have been expanded exponentially. Apart from plant expansions and capacity enhancements, he has given the organisations very sound Quality systems which are capable of standing up to very tough regulatory inspections of recent years. As team player in each organisation he was capable of filing innovative ANDA and DMF products all these years through efficient Regulatory pathway.His strength/ expertise involves selecting good teams, grooming them and meeting organisational expectations all these years.The other area of expertise has been useful is to outsource key products in situations for capacity release in existing plants to make space for new approved products. He has also handled expansion projects involving designing GMP plants for finished dosage form as well as API.