Senior Manager/Director Protein Chemistry, Purification, Formulation

SUMMARY

Accomplished and innovative Biotechnology Professional/Chemical Engineer with significant experience in industrial and pharmaceutical biotechnology. Areas of particular expertise include protein purification, characterization, formulation, analytical development, process development and production. Proven track record of developing, commercializing and providing application support for new products. Mentoring and loyal leader with great ability to build and lead what become very high performing teams. Possesses combination of great technical and scientific knowledge, process creation and management, and fiscal activity resulting in successful revenue generating products.

Protein purification and characterization

Statistical experimental design and analysis

-IEX, HIC, IMAC, SEC, Multimodal, etc.

-DSC, CD, Fluorescence, SDS-PAGE, IEF

-30 years protein experience

Process Development and cGMP operations

Six Sigma Black Belt

Project Leadership

Analytical Development

Technology Transfer and Implementation

PROFESSIONAL EXPERIENCE

Barnett Ventures, Inc. 2015-Current

Owner and CEO, Granite Bay, California

Owner/operator of a DentalFixRx™ franchise. My role encompasses all activities of the day-to-day operations of the franchise and the strategic direction of Barnett Ventures. This includes all technical aspects and all sales and marketing activities within my territory.

DuPont Industrial Biosciences/Danisco/Genencor International 1985-2015

Director, Fabric and Household Care Applications and Customer Solutions, Palo Alto, CA 2012-2015

Leader of the Americas Fabric and Household Care Applications group, one of DuPont Industrial Biosciences’ largest revenue generating Business Units. Responsible for scientific and technical oversight over applications development for existing and new products, oversight for data generation for new product development, launch including assessment and filing of appropriate intellectual property. Managed the team responsible for troubleshooting all technical aspects of product launch/product support and interfaced with Marketing to develop data based marketing claims and value propositions. Interacted with new and current customers to assess their technical needs and develop collaborations for new product offerings. Managed five direct reports.

Assessed technical feasibility of new technology to leverage into new products in order to meet revenue targets for yearly reporting periods. This included day-to-day laboratory work with enzyme formulation and physical biochemistry.

Used engineering financial assessments to evaluate customer cost-in-use, product margin and potential for internal cost cutting based on production costs; this led to strategic decisions on future technology needs.

Determined the feasibility of and streamlined the process for new technical service requests from sales force.

Led a team that identified root cause failures in a novel amylase enzyme due to customer formulation incompatibility that led to >$5MM revenue growth with one customer. This included process, formulation and analytical development.

Accountable for laboratory design, construction, equipment procurement and equipment installation, qualification and assay development; set up Applications Laboratory in Shanghai.

Grew regional revenues 5-8% YOY.

Senior Scientist/Director, Industrial Markets Applications Development, Rochester, NY 2006-2012 Worldwide manager of the Industrial Markets Business Unit applications group. Managed 4 direct reports. For job description see above.

Technical leader of the Industrial Markets worldwide Applications group, with laboratories in Rochester, NY, Leiden, NL and Wuxi, PRC. Led 9 people worldwide. This included day-to-day laboratory work with enzyme R&D.

Active member of the Industrial Markets Leadership Team and Business Integration Team, which guided the strategic and tactical focus of the Business Unit.

Authored and co-authored multiple technology patents that enabled new technology product launches.

Interfaced with many US Government Defense entities on Chemical and Biological decontamination enzymes.

Setup and validated new Applications Laboratory in Palo Alto.

Scientist II/ /Senior Scientist, cGMP Process Development and Production, Rochester, NY 2003-2005

Leader of downstream process development for protein therapeutics including recovery, purification, bulk formulation and bulk filling. Responsible for developing and implementing process development analytical methods. Production of protein made under cGMPs.

Led the purification development and downstream process development for 2 protein therapeutics (intracellularly expressed and refolded) and scaled them into clinical production, resulting in an Investigational New Drug Applications.

Developed purification strategies for protein therapeutics and scaled up to successful Phase I clinical production.

Led formulation development efforts and stabilized proteins against structural and chemical degradation.

Identified, purchased equipment and set up fully functional downstream process development laboratory, process analytical/protein characterization laboratory and cGMP clinical production.

Identified, purchased, wrote equipment standard operating procedures, and validated downstream processing equipment resulting in cGMP compliant clinical production.

Wrote and executed batch records allowing cGMP compliant clinical production.

Developed procedures and performed cleaning verification on cGMP production equipment.

Interfaced with our Quality group to ensure compliance resulting in 100% success in clinical manufacturing.

Authored downstream sections of INDs for submission to the FDA.

Scientist II, BioProcess Engineering, Palo Alto, California 2000-2003

Developed pilot scale (up to 3000 liters) protein recovery processes and transferred to manufacturing (>100,000 liter scale) resulting in consistent corporate revenue growth.

Led analytical implementation team resulting implementation of innovative analytical techniques in fermentation metabolic flux analysis, protein analysis, and mass balance analysis.

Developed and scaled up bio-therapeutic recovery and protein purification processes and delivered pre-clinical samples to research teams.

Used functional genomics and proteomics to rationally design expression strains enabling a product launch by maximizing protein purification yields and purity.

Wrote standard operating procedures and trained pilot plant personnel on recovery and purification unit operations at the pilot scale establishing a consistency in the pilot plant.

Supervised and mentored 2 engineers and 3 process technicians.

Senior Research Associate/Scientist II Worldwide Formulations, South San Francisco/Palo Alto 1995-2000

Led project in the product development, scale-up and manufacture of a granulate enzyme delivery system for a major customer. This work included identification and implementation of a proprietary polymer coating system. This project also entailed interfacing with our customer’s product development team for scale-up and manufacture of the finished product. This directly resulted in > $100MM revenues for Genencor International.

Identified and implemented a liquid formulations strategy based on physical biochemical analyses resulting in cost effective and reproducible formulations of proteins.

Using Statistical Design of Experiments (DOE) developed and transferred liquid formulations to manufacturing resulting in successful new product launches.

Successfully responded to customer specification changes that required reformulation without interruption of delivery.

Research Associate/Senior Research Associate Department of Protein Biochemistry, SSF, CA 1990-1995

Purified and characterized site directed mutants of various enzymes to probe structure-function relationships resulting in identification of new enzymes and root causes of enzyme failures in industrial processes.

Purification and characterization of proteins that directly supported new product research.

Research Assistant/Research Associate, Department of Molecular Biology, SSF, CA 1985-1990

Cloned and expressed multiple fungal cellulase enzymes, including the first ever cloning of a -glucosidase (the key enzyme in cellulosic conversion to glucose) using a novel induction cDNA cloning technique.

EDUCATION

Bachelor of Science, Genetics, University of California at Davis

Master of Science, Chemical Engineering, Stanford University, Stanford, CA

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