Kelsey Binder, Ciss - Eo Email & Phone Number

Maple Grove, Minnesota, United States

As the sole Sterilization Subject Matter Expert (SME) at Anteris, a startup specializing in structural heart technologies, I lead the development and maintenance of the EO Sterilization processes for our TAVR delivery system. My role encompasses ensuring the highest standards of sterilization efficacy and compliance, driving innovation in sterilization practices to meet the rigorous demands of cutting-edge cardiac devices.

Brooklyn Park, Minnesota, United States

As a Subject Matter Expert in microbiology and sterilization for medical devices used in cardiac surgery, I ensured compliance with quality standards and specifications, including ISO 11135, 11137, 17665, 13485, and ANSI/AAMI ST72. I oversaw annual assessments and revalidations of contract EO sterilizers, supported front room audits by notified bodies, and enhanced cleaning and disinfection protocols for reusable devices to meet EU standards. Additionally, I acted as the primary contact for microbiology and EO sterilization for Viant Medical, conducted process qualifications and validations, and led EO sterilization validations and comparative resistance studies. I also served as a core team member for EU MDR remediation, managing efforts to update legacy devices for compliance, and led cleaning, disinfection, and sterilization testing within the Cardiac Surgery unit.

Brooklyn Park, Minnesota, United States

Brooklyn Park, Minnesota

As the sterilization and microbiology Subject Matter Expert on a cross-functional Quality team, I led the EU MDR remediation efforts for Medtronic cardiac surgery devices. I developed ISO/AMI-compliant bioburden and endotoxin testing method validations and reviewed changes and documentation for EU MDR submissions to ensure accuracy and compliance with standards like ISO 11737-1, ISO 10993-7, ISO 11135, and ST72. I also assessed standards to ensure that procedures and documentation remained compliant and maintained frequent communication with stakeholders.

As a Microbiology Lab Technician at WuXi AppTec, I specialized in the growth, maintenance, and enumeration of bacterial strains for advanced research studies. My role involved preparing bacterial cultures for device implant and infection scenarios and measuring bacterial burden in explanted tissues and devices to evaluate antimicrobial efficacy.

In a project-based role at MD Biosciences, I applied my expertise in bacteriology and protein work across several ongoing projects. My responsibilities included optimizing Western Blot techniques and conducting follow-up studies with Salmonella strains to meet specific client requirements. This experience allowed me to contribute to the advancement of critical research while addressing diverse client needs.

Worked to understand the pathogenesis of polymicrobial infections during respiratory disease. My focus was on identifying the actively growing populations of bacteria in patient sputum and the proteins that are being synthesized during infection using click chemistry labeling methods.

Missoula, Montana Area

Preformed brucellosis research as a part of Dr. Celli’s research group in order to identify novel human proteins that interactions with recently discovered Brucella effectors. Designed and executed yeast-two hybrid screens in order to identify several novel interactions that the Celli lab will continue to follow up on in the future in order to better understand the method of Brucella pathogenesis.Worked in the Steele-Mortimer lab on salmonella interactions with the host cell. Assisted in devloping and understanding a model for infecting Human Monocyte-Derived Macrophages with S. typhimurium.

Greater St. Louis Area

Managed a variety of daily maintenance tasks for the lab research for the Chalker Laboratory (2008-2010) and the Levin Laboratory (2010-2012)Also worked from 2011-2012 in the Vogel Laboratory on the secretion system of Legionella pneumophila, trying to identify the protein that acts as the inner membrane receptor for toxins that are secreted from the bacteria into the host cell.

Woods Hole, Ma

Managed all aspects of maintaining a functioning laboratory to support experiments from eight professors over seven weeks. In this summer program with no permanent researchers, I coordinated closely with administration and researchers, quickly learned and executed protocols, and attended daily lectures by leading parasitologists.

Master'S Degree, Microbiology, General

Bachelor Of Arts (Ba), Genomics And Computational Biology, Washington University, St. Louis, Missouri

Activities and Societies: Equestrian Team