Wayne Schrier, PhD

Sr. Quality Scientist/Team Leader

Wayne is an accomplished Product/Process Development and Design Control professional with over fifteen years of professional management experience assuring the successful design, manufacture, and transfer of Class II and III Medical Devices, Diagnostics and Biotech products in line with US FDA cGMP, QSr, and ISO 9000. He is a former Director for Research and Development of Beckman-Coulter, and has tenured in operational management level roles at RPR GenCell, Applied ImmuneScience and Chemtrack, Inc. His depth of cross-functional Design Control experience as a senior level manager with Beckman-Coulter has given Wayne a unique and practical hands-on expertise with Quality System challenges over a diverse range of product / process technologies. He has successfully directed product design and development, manufacturing process development, validation and technology transfer for medical products in compliance with applicable FDA regulations and guidelines. Wayne has a background that includes quality management of firms ranging from start-ups to multinationals facing turnaround challenges; he has a distinguished record of successful strategy implementation and bottom line enhancement. Wayne holds a Ph.D. in Biochemistry from Texas A&M, a BA in Chemistry from Drury University, and an MBA from San Jose State University.

FUNCTIONAL CAPABILITIES:

• Product Development. Designed, developed and commercialized medical devices and diagnostic tests
• Process and Engineering Development. Directed product design and development, manufacturing process development, product and process improvement, validation and transfer to Operations from concept through commercialization.
• Implementation of design control systems and processes to comply with FDA and ISO 9001 requirements.
• Intellectual Property Management. Established patent strategy and managed technology patent processes from disclosure through patent prosecution and issuance
• Research and Development, OEM and Licensing Agreements
• Business Development

EXPERIENCE:

Consultant

Beckman Coulter-Primary Care Diagnostics, Palo Alto, CA

• Director, Product Development
• Manager, Product Development

ChemTrak, Inc., Sunnyvale, CA

• Manager, Assay Development

Applied ImmuneSciences, Inc.

• Group Leader
• Project Leader
• Co-Founding Scientist

EDUCATION:

MBA, San Jose State University, San Jose, CA

Ph.D., (Biochemistry), Texas A&M University, College Station, TX

BA, (Chemistry), Drury University, Springfield, MO