Gautam Gaitonde
About Gautam Gaitonde
Gautam Gaitonde is a Product Development Scientist at Nivagen Pharmaceuticals, Inc. in Sacramento, California, with extensive experience in formulation development and technical documentation for regulatory submissions.
Work at Nivagen Pharmaceuticals
Gautam Gaitonde has been employed as a Product Development Scientist at Nivagen Pharmaceuticals, Inc. since 2017. His role involves writing and reviewing technical documents for Investigational New Drugs (INDs), New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs). He ensures the accuracy and completeness of these documents, contributing to the regulatory compliance of the company's products. Gaitonde also leads technology transfer and scale-up processes, which include the procurement of raw materials and training of manufacturing personnel. His work supports the development of injectable and ophthalmic formulations in accordance with FDA guidelines.
Previous Experience at Pfizer
Prior to his current position, Gautam Gaitonde worked at Pfizer in various roles related to formulation development. He served as a Senior Scientist from 2015 to 2017 and as a Scientist from 2012 to 2015, both in Piscataway, New Jersey. During his tenure at Pfizer, he focused on the development of pharmaceutical formulations and contributed to the advancement of drug delivery systems. His experience at Pfizer provided him with a strong foundation in the pharmaceutical industry.
Educational Background
Gautam Gaitonde holds a Master's Degree in Pharmaceutics from Long Island University, where he studied from 2009 to 2012. He also earned a Bachelor's Degree in Pharmaceutical Sciences from the University of Pune, completing his studies there from 2004 to 2008. His educational background has equipped him with the necessary knowledge and skills to excel in product development and formulation science.
Technical Expertise and Contributions
Gautam Gaitonde possesses expertise in leading the development of injectable and ophthalmic formulations, ensuring compliance with FDA guidelines. He is involved in writing and reviewing publications on new or emerging drug delivery systems. Additionally, he conducts thorough due diligence and technology audits of certified contract manufacturing facilities. Gaitonde plays a significant role in the creation and management of intellectual property strategies related to product life cycles, contributing to the company's innovation efforts.
Collaboration and Leadership Skills
In his role, Gautam Gaitonde coordinates with cross-functional teams to achieve company targets and goals. He participates in efforts to expand laboratory capabilities and provides technical expertise in the selection of new projects. Gaitonde also reviews due diligence packages during asset acquisitions and engages in reviewing and negotiating budget proposals, offering recommendations to upper management. His collaborative approach and leadership skills enhance the effectiveness of project execution within the organization.