Jim Polarine | Principal Consultant, Technical Services

Jim has over three decades of experience in cleaning, disinfection, microbial excursions and disinfectant validation and testing. He holds a master’s degree in biology. Prior to joining STERIS Life Sciences, Jim worked as a Clinical Research Manager with the Department of Veterans Affairs in St. Louis, Missouri and as a Biology and Microbiology Instructor at the University of Illinois and McKendree University.

As a member of the STERIS Life Sciences team for the past 25 years, Jim’s current technical focus is on microbial control in cleanrooms and other critical environments. He conducts on-site training, webinars and high-level technical support for Customers in the biopharmaceutical industry. As a 2019 Parenteral Drug Association (PDA) Michael S. Korczynski Award recipient, Jim was recognized for his contributions toward the development of PDA's international activities. Jim Also received the 2024 PDA’s Distinguished Service Award for leading the PDA Missouri Valley Chapter for four years. He has given lectures around the globe on issues related to cleaning and disinfection, microbial control in cleanrooms and validation of disinfectants. He has also published several PDA book chapters and articles related to cleaning, disinfection and contamination control.

Jim served four years as the President of the PDA Missouri Valley Chapter. He is also the current President Elect of the IEST Executive Board. He is an active member of the International Society for Pharmaceutical Engineering (ISPE), the American Society for Microbiology (ASM), the Society for Industrial Microbiology and Biotechnology (SIMB) and other industry associations.

Alexis Stachowski | Associate Director, QA Microbiology | Regeneron Pharmaceuticals, Inc.

Alexis Stachowski is an accomplished microbiologist with extensive experience in quality assurance and microbiology within the pharmaceutical and biotechnology industries.

Currently, Alexis serves as the Associate Director of Quality Assurance Microbiology for biologics at Regeneron Pharmaceuticals in Rensselaer, NY. In this role, Alexis is responsible for enhancing and maintaining the facility’s bioburden program (contamination control), leading microbial contamination investigations, and ensuring compliance with industry standards for microbial control and mitigation. Alexis also provides strategic input on technology transfer plans and the development of microbiological methods and action limits.

Prior to joining Regeneron, Alexis held several key positions at Charles River Laboratories in Memphis, TN, including Senior Manager of Sterility Assurance and Quality Control Microbiology. During this time, Alexis managed the Contamination Control Strategy for an ATMP multi-product facility, oversaw environmental monitoring programs, and served as a subject matter expert for regulatory inspections by agencies such as the FDA and EMA.

Alexis’s career began at Cognate BioServices, where she progressed from Microbiologist to Manager of Quality Control Microbiology. At Cognate, Alexis supervised laboratory activities, developed microbiological quality policies, and provided expert consultation on microbiological assays and techniques.

In addition to their professional roles, Alexis is an active member of the Parenteral Drug Association (PDA), where they serve as a trainer for courses on aseptic processing and environmental monitoring.

With a strong background in microbiology and a proven track record in quality assurance, Alexis is dedicated to advancing microbial control practices and ensuring the highest standards of product safety and efficacy in the pharmaceutical industry.