Develop the next generation Pan Genera bacterial detection assay. Leverage Verax technical resources to explore other business opportunities.

Interface with customers, troubleshooting and integrating Research and Development activities

Director of R&D Quadraspec, West Lafayette, IN 2008-2009Industry: Biotechnology, Clinical Chemistry, Medical Device, FDA Product Development (DCC)Head of R&D directed product development activities including transfer to manufacturing and quality systems. Also responsible for external communication with current and prospective clients, serving as the technical credibility face for Quadraspec's business interest. Development of the platform and clinical diagnostic products required exceptionally diverse technology and expertise. Technologies included image processing, robotics, GUI development, clinical diagnostics, immunodiagnostics, chemistry, assay development, microarrays, manufacturing, semiconductor fabrication, design control, quality systems, internal and external validation, FDA and USDA guidelines and regulatory affairs.• Successfully directed a highly skilled and diverse group of over 20 scientists and engineers for the delivery of a system including hardware, software, chemistry, quality control and diagnostics• Found chemical solutions for difficult biomolecule applications including non-specific binding, substrate-blood interactions (platelet activation, hemostasis) by novel surface modifications• Employed Agile project management tools with SCRUM implementation, and Six Sigma methodology for the delivery of product features• Responsible for driving an understanding and development of the core technology to the upper management and board members, as well as providing relevant technical, sales and marketing information to prospective clients• Oversaw the implementation of research products to manufacturing in a project management and technology transfer process• Maintained the R&D budget at or below forecast• Delivered product and features in accordance with aggressive project plan milestones

Sr. Product Development Chemist, Quadraspec, West Lafayette, IN Industry: Biotechnology, Clinical Chemistry, FDA Product Development (DCC)Sr. Product Development Chemist responsibilities included the building of or extending the Quadraspec IP and to be the primary driver of internal know-how. The Sr. Product Development Chemist required extensive problem-solving abilities and the distinction to create solutions within a complex matrix of systems. Primary focus was on the development of the physical systems from assay development to quality control.• Responsible for the development of the substrate including surface chemistry, the hydrophobic barrier for sample isolation, immobilization of biomolecules and the development of the proteomic assays• Provided guidance to the programmers for the development of the detection (image processing) algorithm• Responsible for leading technology transfer, QC method development and QC method implementa-tion projects• Involved in the fabrication of world-class microarray, development of silanization methods, bio-molecule immobilization, semiconductor grade fabrication, MEMS development, microfluidics, and end-point assay development

Sr. Scientist, Polymer Technology Systems, Indianapolis, INIndustry: Biotechnology, Clinical Chemistry, Medical Device, FDA Product Development (DCC)Lead scientist for the development of the first LDL dry-strip POC diagnostic test strip. The Sr. Scientist responsibilities included building the core IP, give guidance to current and existing products and product support and troubleshooting.Key Accomplishments• Developed first FDA approved direct LDL dry strip~Formulation and DOE ~Architecture Development~Data Analysis~Clinical Studies~Manufacturing Method and Equipment Design~510K Submissions• Designed a novel single test strip holder for improved performance• Reduced Cost of Goods for single hole tests by 30% or greater based on membrane savings, streamlining strip QC, reduced labor and reduced waste• Provided CAD Drawings for all equipment and mold design for quotes and technical reference • Designed manufacturing system capable of automation for LDL or other single test strip system• Developed Non-Precipitating HDL with superior performance characteristics• Developed formulation and strip architecture of non-glass fiber containing dry test strips• Provided technical and product support for existing products• Provided formulation insight to key intellectual property development and IP management• Instrumental in troubleshooting manufacturing and chemical formulation issues with current products• Managed and conducted clinical testing for direct LDL test strip for submission to FDA• Designed and built prototype manufacturing equipment under budget followed by transfer to manufacturing scale• Interacted with vendors, suppliers and contract workers to deliver under-budget and within project plan time-line• Provided Improvements to current single hole triglyceride and HDL test strips• As primary or as sole investigator, wrote 5 patents with 3 patents granted

Responsible for investigation and documentation of deviations relating to the manufacturing and processing procedures of the parental manufacturing division of Diversified Hospital Care at Eli Lilly. Was responsible for the identification of Root Cause and submission of proposed solutions. Relevant areas of manufacture included level A clean-room environments, injectable drug manufacturing, filling lines and biological monitoring. Requiredextensive knowledge of pharmaceutical cGMP and FDA regulations. Was offered permanent position within Eli Lilly for manufacturing and engineering support.