Meet Our Experts
Mike McGrew, P.E., MSME
Vice President, Operations
FL, USA
Mike McGrew joined WuXi AppTec in 2017, and currently serves as Vice President, Operations, focusing on operational excellence and streamlining client services. He brings more than 30 years of experience working with medical devices. His expertise spans diverse disciplines, including business strategy, site/plant management, program management, quality, and engineering. Before joining WuXi AppTec, Mr. McGrew held leadership positions with Covidien/Medtronic, Hospira, and Abbott Laboratories. Mr. McGrew earned a master’s degree in mechanical engineering from Tufts University and a bachelor’s degree from Southeastern Massachusetts University. He is also registered as a Professional Engineer in California.
Sandi Schaible
Executive Director, Analytical Chemistry and Regulatory Toxicology
MN, USA
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 opened 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. Ms. Schaible 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
PA, USA
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, Dr. Ehman offers expertise in toxicological risk assessments for medical devices, food and beverage products, and electronic nicotine delivery systems. 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. Ehman received her Ph.D. in parasitology from McGill University and conducted postdoctoral research at the US EPA in developmental neurotoxicology.
Dr. Thomas Halbritter, Ph.D.
Director, Chemistry Operations
Munich, Germany
Dr. Thomas Halbritter joined WuXi AppTec in July 2024 as Director, Chemistry Operations, overseeing our new extractables and leachables lab in Munich, Germany. He leads the chemistry team for the lab, ensuring the delivery of precise and reliable analytical results to support 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, MSc
Principal Toxicologist
MO, USA
Mark Cabonce joined WuXi AppTec in 2015 and supports our clients as a Principal Toxicologist focusing on medical devices and combination products. Mr. Cabonce has extensive experience managing regulated in vivo and in vitro acute toxicology studies, assessing formulation dossiers for GHS classification and labeling, and preparing risk assessments supporting domestic and international product registrations. He has managed pharmacokinetic and preclinical safety evaluation studies for a broad range of pharmaceutical and agrichemical clients under prevailing EPA, FDA, and OECD guidelines. Mr. Cabonce holds 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
Group Manager, Reprocessing and Sterilization Validation Services
FL, USA
Dan Fowler joined WuXi AppTec in 2017 and is the Group Manager, Reprocessing and Sterilization Validation Services for medical devices, biologics, and combination products. Mr. Fowler brings over 20 years of experience in third-party medical device reprocessing. He 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. Mr. Fowler’s experience allows him to streamline the identification and validation of analytical laboratory assays and develop best practices in method development for inoculation/extractions and efficient cleaning/disinfection strategies for reusable medical devices. Mr. Fowler is a member of the AAMI Sterilization Standards Committee.
Britt Jones
Group Manager, Chemistry and Package Testing
GA, USA
Britt Jones joined WuXi AppTec in 1998 and supports our clients as Group Manager, Chemistry and Package Testing Services for medical devices, biologics, and combination products. With over 20 years of operations and project management experience at WuXi AppTec, Mr. Jones’s broad knowledge in microbiology, chemistry, sterility, bioburden, microbial ID, and packaging enables him to provide the scientific and regulatory advice that medical device developers need to avoid pitfalls and failure points. As an industry expert, Mr. Jones excels in packaging validation and cold chain transportation studies. 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).
Dr. Cindy Dingee, DVM
Histopathology Operations Manager and Veterinary Pathologist
MN, USA
Dr. Cindy Dingee joined WuXi AppTec in 2005 and brings over 20 years of experience to her role as Histopathology Operations Manager and Veterinary Pathologist. 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. Dr. Dingee leads and participates in cross-functional process improvement projects and evaluates toxicological, intramuscular, and subcutaneous custom studies, as well as wound-healing and osteoinduction studies. As a staff pathologist, Dr. Dingee creates study pathology reports per GLP and GMP 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, MBA, Ph.D.
Director, Technical Services
GA, USA
Dr. Jayshree Patel joined WuXi AppTec in 2023 as Director, Technical Services, leading programs to expand service areas and revenues, notably in microbiology and regulatory compliance. Dr. Patel has pioneered more than 100 test protocols, advanced CAPA and risk assessments, and implemented environmental monitoring and biosafety programs. She brings experience in establishing microbiology labs and manufacturing facilities and expertise in regulatory standards (e.g., USP, EP, ICH, ISO, FDA, etc.). Dr. Patel holds an MBA specializing in organizational management and leadership and a Ph.D. in microbiology.
Dr. Beverly Lundell, MSc, Ph.D.
Scientific Director, Custom Studies
MN, USA
Dr. Beverly Lundell joined WuXi AppTec in 2010 and serves as Scientific Director, Custom Studies. During a prolific career in biomedical science focusing on preclinical study designs, regulatory compliance, and innovative testing methods, Dr. Lundell has developed over 600 study designs, authored study reports for regulatory agencies, and pioneered in vivo and in vitro testing methods. Dr. Lundell’s work emphasizes reducing animal use in testing, improving biocompatibility assessments, and advancing toxicology risk assessment. Dr. Lundell earned a Ph.D. 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.
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