Cowper Sciences is an early stage company focused on proteomics.

iCarbonX is a global biotech company with a goal of transforming both health and wellness by unlocking the power of deep and dynamic digitization of biology. When iCarbonX acquired HealthTell for $129M as part of a 3-company merger, I was selected to lead the Global Digital Biology Operations team, which included a clinical operations team in China and manufacturing operations in Arizona.CLINICAL LABORATORY OPERATIONS OBJECTIVE: Take responsibility for a high complexity clinical laboratory in Shenzhen, China with a team over 60+ people. RESULT: Within 30 days, I established a collaborative team on site and instituted a balanced scorecard focused on quality. Within the first six months, we decreased test failures by 50% and improved median TAT by >25%.TECHNOLOGY DEVELOPMENT OBJECTIVE: Conceptualize and demonstrate a proprietary application enabling the parallel detection of thousands of human proteins with high specificity and low sensitivity.RESULT: Established proof of concept and feasibility of a broadly enabling massively parallel detection platform. Established a scalable infrastructure to reduce consumable costs from >$100 to <$10.GENERAL MANAGEMENT OBJECTIVE: Work with Committee for Foreign Investment in the US (CFIUS) to monitor compliance associated with the National Security Agreement (NSA).RESULT: Crafted strategy, business plan, and pitch deck for divestiture of developed technology assets, served as security officer ensuring compliance with NSA, closed sale of assets.

HealthTell was an early stage start-up company developing powerful tools to monitor health status by measuring the body’s unique response (it’s “immunosignature”) to a given disease or disease state. I was recruited to join as leader of operations, with responsibility for peptide array process development and pilot operations. HealthTell was purchased by iCarbonX for $129M in April 2018.STARTUP OBJECTIVE: Achieve feasibility.RESULT: Within the first 6 months, established 2500 sq ft process development/pilot manufacturing site with the capacity to build peptide microarrays for over 400,000 tests per year. Led reviews with existing and potential investors as part of technical due diligence. Provided quarterly updates to BOD and served as a key contact for lead investors. We received >$40M in Series A and Series B investments.TECHNOLOGY DEVELOPMENT OBJECTIVE: Achieve commercial readiness.RESULT: Transformed a laboratory process into a commercially ready peptide array platform. Reduced array variation by 90+% and improved pilot capacity by 400% while maintaining the same direct labor staffing levels. Initiated and demonstrated feasibility of patent-pending application. The developed IP was the core of a spinout venture, RubrYc Therapeutics.OPERATIONS OBJECTIVE: Develop process and quality control infrastructure to ensure quality throughout the process and confirmation of function for product release. RESULT: Established process and quality control infrastructure. Methods included innovative surface characterization techniques such as spectroscopic ellipsometry and MALDI MS as well as functional antibody binding assays. Also established safety, purchasing, quality, and operational policies to support rapid product and peptide array process development and manufacturing. Recruited, developed, and retained critical technical and administrative talent to staff pilot, operations, and technical teams.

Complete Genomics (GNOM) was the complete human genome sequencing company that developed and commercialized an outsourced service. I was recruited to lead the operations management team (50 employees) with an annual spend of $20M. Responsibilities included the consumable manufacturing and laboratory activities required to sequence human genomes at scale.LABORATORY OPERATIONS OBJECTIVE: Build operational capacity with high-performance teams.RESULT: Recruited management team for technical operations and production teams. Expanded production capacity and transitioned to 7-day operation, resulting in 3X production increase within 1st year. Stabilized reagent manufacturing within the first 90 days and established core team to continuously improve reagent production.

Provided technical and management consulting for tools, diagnostics, and medical device companies. Services included:• Technical consulting for process development• Operational consulting• Business and execution planning• Product development • Project management

Codon Devices was a privately held biotechnology company focused on enabling commercial applications of synthetic biology. I was recruited to become a member of the new management team.GENERAL MANAGEMENT OBJECTIVE: Secure financing to build the company.RESULT: Together with management team, secured $11M in financing to transform the company from biological parts supplier into a bio-product development organization. STARTUP DEVELOPMENT OBJECTIVE: Establish organizational structure to complete product recall and initiate new sales.RESULTS: Completed product recall within first 2 months. Led operational change to re-launch custom gene synthesis product line within first 3 months. Dramatically improved processes as demonstrated by first pass yields and on time deliveries. Service levels improved by a factor of 3.BUSINESS TRANSFORMATION OBJECTIVE: Transform the company from biological parts supplier to a bioproduct development organization.RESULTS: Surpassed shipment and revenue targets during company transition. Established project oversight infrastructure to successfully manage legacy collaborations. Led R&D team to achieve aggressive feasibility targets in renewable chemicals field.

As VP of Manufacturing for this biotech firm, I led team of 70+ people with an annual budget/expenses of $8M+. Responsibilities included technology transfer, instrument manufacturing, reagent manufacturing, quality control, purchasing, logistics, and strategic partnership management. MANUFACTURING OBJECTIVE: Lead manufacturing transition from R&D support through early stage commercialization to focused operational units.RESULTS: Assisted in establishing a strategic partnership with Roche Applied Science. This was a 5-year agreement in which 454 would receive up to $62M for milestones, research funding, royalties, and license fees. Two years into the partnership, Roche acquired the company for $154M.Delivered products to RAS supply chain and 454 Sequencing Center. Exceeded revenue goals for 3 consecutive years: >$18M 2005; >$35M 2006; >$70M 2007Led group of 4 that negotiated 15 supply agreements within 6 weeks as part of a milestone demonstrating manufacturing risk mitigation.Launched First Product Platform within 4 months of signing the agreement.Received Gold Award in Wall Street Journal’s Global Technology Innovation Competition Committee.Actively managed relationship with Roche Applied Science (RAS) as member of R&D and Operations Steering Committee.Led manufacturing and quality integration teams post-acquisition.Led organizational transformation from an R&D support function to a true manufacturing environment.Developed organization for scalable growth and tripled staff to increase reagent production capacity 6-fold and instrument production 4-fold while establishing scalable quality/process control infrastructure.Partnered with Roche Applied Science personnel to implement best practices to ensure quality, service levels, and productivity.Developed Materials Group to handle 1700+ SKU’s and manage 50+ inventoried products.

Led department of 70 people with budget over $10M/year. Responsibilities included chemistry, chip design, pilot operations for arrays and reagents, quality control, process development, engineering, and test development groups.BUSINESS PROCESS OBJECTIVE: Developed business process, as member of initial steering committee, which included business plan approval, marketing and development plan oversight, and life cycle management review for all commercially launched products. RESULT: 40% of ’03 revenue came from new products launched in ’03 with revenue within +/- 5% of forecast. Process recognized by Product Development & Management Association (PDMA) with Outstanding Corporate Innovator Award ’04.PRODUCT OBJECTIVE: Redesign expression profiling product line.RESULT: Led cross-functional, multi-site team to completely re-design expression profiling product line. Technology development, product development, systems integration, and commercial launch occurred in 13 months.The 2.0 platform enabled the analysis of the most comprehensive whole genome arrays and incorporated instrumentation and consumables. The Human Genome U133 Plus 2.0 array made Time Magazine’s list of coolest inventions for your health in November 2003.Bridged basic research to manufacturing and accelerated rate of implementation of innovation by integrating new and existing technologies for streamlined array production Technologies were derived from the semiconductor, flat panel, and biotechnology industries. Spearheaded process development, validation, and management discipline that resulted in reducing costs of commercial arrays by 40% while increasing their value.Worked with business development to establish contracts with major diagnostics partners; one relationship secured a $70M up-front payment. Transitioned reagent pilot to production mode. Sales of internally manufactured reagents increased over 10X during 2-year period.