Alexis Stachowski

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 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 a 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 Stachowski is dedicated to advancing microbial control practices and ensuring the highest standards of product safety and efficacy in the pharmaceutical industry.