Nikunj Soni, Pmp®
About Nikunj Soni, Pmp®
Nikunj Soni, PMP®, is a Product Development Scientist with extensive experience in formulation development and quality by design. He has worked for several pharmaceutical companies, including Sun Pharma, Patheon, Thermo Fisher Scientific, and currently ANI Pharmaceuticals, Inc.
Current Role at ANI Pharmaceuticals
Nikunj Soni serves as a Product Development Scientist at ANI Pharmaceuticals, Inc. since 2019. In this role, he is responsible for coordinating with project management teams to monitor project status and ensure timely responses to regulatory agencies' queries. He also verifies manufacturing process parameters and recommends control strategies for Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs). His work contributes to the development of pharmaceutical products in compliance with industry standards.
Previous Experience in Pharmaceutical Development
Prior to his current position, Nikunj Soni held various roles in pharmaceutical development. He worked at Thermo Fisher Scientific as a Formulation Development Technologist from 2017 to 2019, and at Patheon Inc. as a Formulation Development Technologist II from 2012 to 2017. His experience includes conducting trials to study the impact of excipients within SUPAC guidelines and reviewing scientific literature to recommend formulation development strategies. He also worked at Patheon Inc. as a Processing Technologist from 2007 to 2012.
Early Career in Pharmaceutical Production
Nikunj Soni began his career in the pharmaceutical industry at Alembic as a Production Chemist from 2002 to 2004. He then joined Sun Pharma Advanced Research Company Ltd. as a Senior Production Officer from 2004 to 2006. His early experiences laid the foundation for his expertise in production processes and quality assurance in pharmaceutical development.
Education and Qualifications
Nikunj Soni holds a Bachelor of Science degree in Chemistry from Sardar Patel University, where he studied from 1993 to 1996. He furthered his education at Seneca College of Applied Arts and Technology, achieving a specialization in Industrial Pharmaceuticals Chemistry from 2007 to 2008. His educational background supports his extensive knowledge in formulation and process development.
Expertise in Quality by Design
Nikunj Soni possesses a detailed understanding of Quality by Design (QbD) principles in formulation and process development. His expertise enables him to implement effective strategies that enhance product quality and compliance with regulatory standards. He coordinates with analytical lab supervisors to ensure sample requirements are met and timelines for testing are adhered to.