Manager Microbiology & Sterility
SGS North America Inc.
Dhavalkumar Jain is a highly accomplished Quality Professional with over 17 years of experience across the Pharmaceutical, Biologics, Cell therapy, and Medical Device Industries. His expertise lies in Sterility, Quality Control and ensuring robust Quality Assurance. Mr. Jain currently serves as a Manager of Microbiology and Sterility at SGS Pharma in Fairfield, NJ, a role he has held since July 2022. Prior to his current role, Mr. Jain spent over six years at Johnson & Johnson Products Inc. in Skillman, NJ. He was a Laboratory Operation Supervisor from January 2016 to July 2022 , where he provided technical, supervisory, and operational oversight to the R&D Microbiology group. Mr. Jain's technical skills encompass a wide range of critical areas, including:
• Microbiology Lab Operation and Managing and Directing laboratory operations.
• Sterility Assurance, including Sterility and Endotoxin method verifications per USP.
• Validation of equipment and IT systems (Electronic notebooks), including IQ, OQ, PQ.
• Quality Assurance, Aseptic Processes and Practices, and Contamination Control and Risk Management.
• Root Cause Analysis and Investigations using tools like 5Why and 6sigma.
• Environmental Monitoring (EM) programs, Cleanroom design and classifications (ISO 14644).
Mr. Jain holds a Master of Science in Biology (GPA: 3.7) from Fairleigh Dickinson University, completed in December 2009. He also has a Bachelor of Engineering in Biotechnology. He is a published author, contributing a chapter on "Microbiological Methods for Drug Substance" to the book Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Third Edition (2024, published by ELSEVIER). His commitment to professional development is highlighted by his certifications, including Six Sigma: Green Belt (2022) and Certified Quality Improvement Associate from the American Society of Quality (2012).