Marlys E. Weary
Senior Consultant, Pyrogen Testing

Marlys Weary is a consultant to the medical device and pharmaceutical industries, with more than 35 years of experience in the field of microbiology research, pyrogen testing and water systems.

• For the past 15 years, Marlys has been a consultant to the medical device and pharmaceutical industries specializing in the area of pyrogen testing and water systems.  She has provided technical support for product and process problem solving, educational seminars, LAL pyrogen test training, preparation of validation programs for depyrogenation and non-pyrogenic manufacturing, and resolution of U.S. and International regulatory compliance issues.
   
• Prior to becoming a consultant, Marlys spent 28 years working for Baxter Healthcare Corporation, a world-wide leading supplier of healthcare products, systems and services.
   
• Marlys was responsible for Baxter Healthcare Corporation’s pyrogen and safety test technical support which included validation of rabbit testing and LAL tests for new products, troubleshooting process control pyrogen problems, and maintaining corporate biological control specifications.  She held positions of increasing responsibility in management and technical expertise and provides insight into problem solving from a technical and management perspective.

Marlys continues to be active in industry activities, task forces and working groups.

• She held the position of Chairman of the Bacterial Endotoxins Test Task Force for the Parenteral Drug Association (PDA). 
   
• She was appointed to the USP Advisory Panel on Microbiological Control and Process Validation for the 1995-2000 revision cycle of the United States Pharmacopoeia.
   
• She is currently a member of the International Endotoxin Society and the LAL Users Group.

Marlys holds a Bachelor of Arts in Biology from Valparaiso University, a Masters of Science in Anatomy and Histology from the University of Illinois, Medical Center in Chicago, and a Masters in Business Administration from Lake Forest School of Management.

Marlys is the holder of a patent for an improved method for determining endotoxin concentration and is the author and co-author of over 35 articles or chapters in the USP.  She has presented numerous lectures for training purposes and has been an invited speaker for the FDA, PDA, Australian National Biological Standards Laboratory, and Scandinavian Association on Contamination Control.