Kathryn Herring                                                                                                                 

Sr. Scientist

Kathryn has 26 years of experience in research and development, technical support, and manufacturing support in the biomedical/medical device and pharmaceutical industry. A former Manager of Technical Support for a Fortune 500 company, Kathryn has vast experience in developing products and managing product development teams, as well as product reformulations and technical support to manufacturing operations.   Expertise includes Failure Analysis with corrective action implementation, validation of test methods, formulation, product, and processes including characterization studies and specification development, manufacturing technologies and strategies, product transfer, product support, process design and scale-up, process improvements, technical writing, blood gas / electrolyte technology, protein purification and lyophilization technology.   Additional strengths include managerial skills, solid technical background, and strong problem solving ability, team player and results oriented.

EXPERIENCE...

• As Sr. Scientist for Bioteknica, developed IQ/OQ/PQ validation protocols for equipment, instrumentation, and purified water systems. Developed characterization studies to optimize and determine specifications followed by validation for test methods, processes and product formulations using statistical methods and experimental design. Used Common Process technology to bring existing validated products and/or processes into compliance with the FDA requirements.
• As Manager of Technical Support for a leading Diagnostics manufacturer, led a group of eight scientists in efforts to support operations. Set-up Technical Support group where none existed before, establishing objectives, responsibilities, which resulted in the implementation of a Failure Analysis System, and the transfer of several reformulated products to Operations.
• Utilized Failure Mode Analysis to identify potential weaknesses in manufacturing processes that resulted in several changes to be incorporated manufacturing documentation.
• Worked directly with all aspects of operations in carrying out failure analysis, root cause analysis and implementation of corrective actions.   Reduced the time of closure and the number of open failures by   50%.
• Led a team to review raw material specifications and implement revised specifications that would significantly reduce product failures due to quality of raw materials.
• Designed, developed and released several new products including: Blood Gas / Electrolyte Reagents, calibrators and controls, Cerebral Spinal Fluid Controls, Tumor Marker Controls.
• Reformulated several products that resulted in cycle time reduction, product standard cost reduction and significant product improvements.   These products included:   Comprehensive Chemistry Controls and Calibrators, Immunoassay Controls, Cardiac Controls, Urine Controls.
• Developed or redesigned existing products for use as OEM (Other Equipment Manufacturer) Products, Proficiency Survey Products (College of American Pathologists).
• Developed manufacturing procedures for new or existing products including quality control procedures, filling and packaging instructions.
• Developed and patented several processes for the purification of proteins that resulted in a cost savings of 50 to 75% as compared to purchasing the raw materials.   Proteins include: Prealbumin, Alphafetoprotein (AFP) and various tumor markers.   Prealbumin and AFP processes resulted in a savings of $200,000 per year.
• Awarded eight patents covering the formulations and processes of several product formulations including: Blood gas controls and calibrators, Cerebral Spinal Fluid Controls and Tumor Marker Controls.
• Successfully managed validation projects for test methods, new products, equipment, purified water systems and clean rooms.   Member of the Validation Review Board responsible for Validation Master plan, review of company wide validations and validation training.

POSITIONS HELD...

• Sr. Scientist                                       BioTeknica
• Manager of Technical Support          Dade-Behring, Inc.
• Group Leader of R&D                       Dade International, Inc.                                      
• Senior Scientist                                Baxter Diagnostic, Inc.                                      

EDUCATION...

• B.S.   Chemistry                                University of Florida

CONTINUING EDUCATION...

• Quality Engineer (CQE)
• Project Management
• Validation workshops (software, equipment, processes, test methods)