Meet Our Experts

Mike McGrew, P.E., MSME

Vice President of Operations

Mike McGrew has more than 30 years of medical device experience working with medical devices. His experience spans diverse disciplines including business strategy, site/plant management, program management, quality, and engineering. Before joining WuXi AppTec, Mike held a number of leadership positions with Covidien/Medtronic, Hospira and Abbott Laboratories.

Mike earned a master’s degree in Mechanical Engineering from Tufts University and a bachelor’s degree from Southeastern Massachusetts University. Mike is also registered as a Professional Engineer in California. Mike is WuXi AppTec’s Vice President of Operations, focusing on operational excellence and streamlining client services to pursue world class performance.

Sandi Schaible

Executive Director, Analytical Chemistry and Regulatory Toxicology

Sandi Schaible joined WuXi AppTec in 2011 and is responsible for oversight and direction of WuXi AppTec’s Analytical Chemistry and Regulatory Toxicology departments in St. Paul, Minnesota, and our new lab in Munich, Germany, which is opening in late 2024. With over 30 years of experience, Ms. Schaible leads a team responsible for providing custom chemistry testing services, including extractables/leachables, materials characterization, and toxicological risk assessments. Ms. Schaible has worked in the pharmaceutical, medical device, environmental, and R&D industries, including over 20 years of analytical experience in GLP, GMP, FDA, and ISO regulated laboratories. She is actively involved in standards development and is an international and U.S. delegate for TC 194/WG14, the technical committee for ISO 10993-18.

Dr. Kimberly Ehman, Ph.D., DABT

Director, Regulatory Toxicology

Dr. Kimberly Ehman joined WuXi AppTec in 2020 providing over 18 years of toxicology and medical device experience. Supporting our clients as Director, Regulatory Toxicology, she offers expertise in toxicological risk assessments for medical devices, food and beverage products, and electronic nicotine delivery systems. She received her Ph.D. in parasitology from McGill University and conducted postdoctoral research at the US EPA in developmental neurotoxicology. In her current position as Director, Regulatory Toxicology, Dr. Ehman provides medical device manufacturers and suppliers with technical and regulatory support for biocompatibility test programs and conducts quantitative toxicological risk assessments to support product safety and risk management decisions.

Dr. Thomas Halbritter, Ph.D.

Director, Chemistry Operations

Dr. Thomas Halbritter joined WuXi AppTec in July 2024 as the Director, Chemistry Operations, overseeing our new extractables and leachables lab in Munich, Germany. He leads the chemistry team for the lab, ensuring that our operations deliver precise and reliable analytical results to support our clients’ product safety and compliance. Dr. Halbritter brings extensive experience in analytical chemistry and laboratory management. He holds a Ph.D. in Organic Chemistry and Chemical Biology from Goethe University Frankfurt and has a strong background in developing innovative solutions for complex scientific challenges.

Mark Cabonce

Principal Toxicologist

Mark Cabonce joined WuXi AppTec in 2015 and supports our clients as a Principal Toxicologist focusing on medical devices and combination products. Before joining WuXi AppTec, he was a toxicologist managing regulated in vivo and in vitro acute toxicology studies, assessing formulation dossiers for G.H.S. classification and labeling, and preparing risk assessments supporting domestic and international product registrations. Mr. Cabonce also managed pharmacokinetic and preclinical safety evaluation studies for a broad range of pharmaceutical and agrichemical clients under prevailing EPA, FDA and OECD guidelines. He earned a master’s degree in biology from St. Louis University and has been a Diplomate of the American Board of Toxicology since 2005.

Dan Fowler

Principal Reprocessing Scientist

Dan Fowler joined WuXi AppTec in 2017 and supports our clients as the Group Manager of Reprocessing and Sterilization Validation Services for medical devices, biologics, and combination products. He is also a member of the AAMI Sterilization Standards Committee.

With more than 20 years of experience in medical device third-party reprocessing, Dan is an expert in the interpretation and application of AAMI TIR30, overseeing the following modalities for sterilization: radiation, moist heat (gravity or prevacuum), ethylene oxide (EO), and dry heat. Dan’s experience allows him to streamline identification and validation of analytical laboratory assays and develop the best practices in method development for inoculation/extractions and efficient cleaning/disinfection strategies for reusable medical devices.

Britt Jones

Chemistry and Package Testing Manager

Britt Jones joined WuXi AppTec in 1998 and supports our clients as the Group Manager of the Chemistry and Package Testing Services for medical devices, biologics, and combination products. He serves on the ASTM Committee on Packaging (ASTM D-10) and is a member of and certified by the International Safe Transit Association (ISTA) and the Institute of Packaging Professionals (IoPP).

With over 20 years of operations and project management experience at WuXi AppTec, Britt’s broad knowledge in microbiology, chemistry, sterility, bioburden, microbial ID, and packaging, enables him to provide the scientific and regulatory advice that medical device development needs to avoid pitfalls and failure points. As an industry expert, Britt excels in packaging validation and cold chain transportation studies.

Cindy Dingee, D.V.M

Histopathology Operations Manager and Veterinary Pathologist

Dr. Cindy Dingee joined WuXi AppTec in 2005 and supports our clients as Histopathology Operations Manager and Veterinary Pathologist with over 20 years of experience. Dr. Dingee maintains timelines and first in/first out processes in her managerial role. She also manages laboratory planning, development, and equipment installation and qualification, responding to client inquiries about study capabilities and department capacity. She leads and participates in cross-functional process improvement projects and evaluates toxicological, intramuscular and subcutaneous custom studies, and wound-healing and osteoinduction studies. As a staff pathologist, Dr. Dingee creates study pathology reports per G.L.P. and G.M.P. guidelines, develops histopathology protocols, consults with principal investigators and validates pathology systems. Dr. Dingee earned a doctoral degree in veterinary medicine from Ross University, West Indies. She spent a clinical year at the University of Minnesota, where she completed a residency in anatomical pathology.

Dr. Jayshree Patel, Ph.D.

Director of Technical Services

Dr. Jayshree Patel joined WuXi AppTec in 2023 where she supports our clients as Director of Technical Services, spearheading programs to expand service areas and revenues, notably in microbiology and regulatory compliance. With an MBA specializing in organizational management and leadership, a doctorate in microbiology, and a career spanning more than 18 years across various leadership roles in pharma/biotech, Dr. Patel is a visionary in strategic planning and quality management. She has pioneered more than 100 test protocols, advanced CAPA and risk assessments, and implemented environmental monitoring and biosafety programs. Dr. Patel’s leadership in establishing microbiology labs and manufacturing facilities, coupled with her expertise in regulatory standards (e.g., USP, EP, ICH, ISO, FDA, etc.), position her as a key figure to lead WuXi AppTec’s technical and regulatory innovation.

Dr. Beverly Lundell, Ph.D.

Scientific Director of Custom Studies

With a prolific career in biomedical science focusing on preclinical study designs, regulatory compliance, and innovative testing methods, Dr. Beverly Lundell joined WuXi AppTec in 2010 and supports our clients as Scientific Director of Custom Studies. She earned a doctorate in microbiology, immunology, and cancer biology from the University of Minnesota; a master’s degree in nutrition-metabolic research from the same institution; and a bachelor’s in medical technology from Augsburg College. Dr. Lundell’s contributions include developing over 600 study designs, authoring study reports for regulatory agencies, and pioneering in vivo and in vitro testing methods. Her work emphasizes reducing animal use in testing, improving biocompatibility assessments, and advancing toxicology risk assessment.