Director, Analytical Chemistry
With over 25 years’ experience, Ms. Schaible is responsible for oversight and direction of WuXi AppTec’s Analytical Chemistry department in St Paul, Minnesota. The analytical staff she manages is responsible for providing custom chemistry testing services including extractables/leachables, materials characterization and target analysis testing, method development, method validation as well as standardized testing including compendial testing.
Ms. Schaible received her Bachelors of Science in Chemistry from Winona State University, and has experience working in the pharmaceutical, medical device, environmental and R&D industries, including over 15 years of analytical experience in GLP, GMP, FDA and ISO regulated laboratories. Ms. Schaible provides technical guidance and testing program design, and is an international and U.S. delegate for TC 194, the technical committee for ISO 10993.
Dr. Sherry Parker, Ph.D.
Senior Director of Regulatory Toxicology
Dr. Parker has over 20 years of toxicology and medical device experience, and is an expert in analytical, pharmacological, and toxicological evaluations of medical devices and combination products. Dr. Parker received her Ph.D. in Molecular and Cellular Pharmacology from the University of Miami. In her current position as WuXi AppTec Medical Device Testing’s Senior Director of Regulatory Toxicology, Dr. Parker provides manufacturers with guidance on global regulatory and technical requirements and testing program design.
Dr. Parker is also the US Co-Chair of the AAMI/ Biological Evaluation (AAMI/BE) Committee the national mirror committee for ISO 10993. In addition, she is currently an international ISO expert of TC 194, the technical committee for ISO 10993, and is the Past-President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology.
Dr. Kimberly Ehman, Ph.D., DABT
Technical Director of Regulatory Toxicology
Dr. Ehman has over 18 years of toxicology and medical device experience, with expertise in toxicological risk assessments for medical devices, food and beverage products, and electronic nicotine delivery systems. She received her PhD in parasitology from McGill University and conducted postdoctoral research at the US EPA in developmental neurotoxicology. In her current position as Technical Director of 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.
Cindy Dingee, DVM
Histopathology Operations Manager and Veterinary Pathologist
Dr. Cindy Dingee serves as WuXi AppTec Medical Device Testing’s Histopathology Operations Manager and Veterinary Pathologist in the Lab Testing Division. She has over 20 years of experience.
In her managerial role, Dr. Dingee is responsible for maintaining timelines and first in/first out processes. 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, 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 principle investigators and performs pathology systems validations.
Dr. Dingee received her D.V.M. from Ross University, West Indies. She spent a clinical year at the University of Minnesota, where she completed her residency in anatomical pathology.
Mark R. Cunningham, Ph.D.
Senior Director of Science and Technology
Dr. Mark Cunningham joined WuXi AppTec in 2018, as Senior Director of Science and Technology. With a career spanning more than three decades in the biopharmaceutical and medical device research and testing industries, he has vast scientific experience in discovery, development and characterization of biopharmaceutical, medical device and combination products. Dr. Cunningham’s area of expertise is the physiology, pharmacology and pathobiology of cardiovascular disease, with a specific interest in preclinical models of inflammation, cardiovascular disease and safety pharmacology.
Dr. Cunningham received a B.S. in BioMedical Science from Grand Valley State University in Grand Rapids, Michigan, a Ph.D. in Pharmaceutical Sciences from the University of Kentucky, and completed his post-doctoral training at the University of Michigan Medical School. Over the course of his career he has published over 65 papers and abstracts, and presented at national and international scientific meetings.
Principal Reprocessing Scientist
Dan Fowler is the group manager of reprocessing and sterilization validation services for medical devices, biologics, and combination products at WuXi AppTec. 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.
Chemistry and Package Testing Manager
Britt Jones is the group manager of the Chemistry and Package Testing services for medical devices, biologics, and combination products at WuXi AppTec. 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.