Verpond is researching and developing an industrially scalable marine microalgae cultivation system and processes for production of biobased products, including fuels, fertilizers, feeds, and food.President• Invented novel marine microalgae cultivation system.• Served as principal investigator for Verpond’s NSF SBIR award.• Performed experiments to select favorable strains for scale-up and developed culture conditions targeted for large-scale cultivation.• Performed scale-down experiments showing proof-of-concept for large scale cultivation system.• Managed worldwide patent filings, including patents granted and patents pending.

Bioprocess, QA, and operations consultant focused on helping companies produce their products for development and testing in a timely and cost effective way. Providing professional services setting up operations, developing processes, establishing and maintaining quality systems, and performing clinical manufacturing.

Abzena provides the most complete set of solutions in integrated early discovery to mid-phase biotherapeutic and ADC drug development services in the pharmaceutical industry.Expanded and transformed the company’s PD team from 15 to 30 engineers and scientists to develop processes for new products advancing from research to early clinical development or from early clinical development to late stage clinical trials and commercial manufacturing.• Reorganized and built the PD team to handle large increases (multiples) in work load.• Implemented improved operations, including better utilization of high throughput tools and platform processes to speed PD for antibodies, other protein framework drugs, and ADCs.• Worked extensively with clients to help them meet their CMC needs.

Inhibrx is a public, science-first, self-sustainable biotherapeutics company. Inhibrx developed an efficient and productive scientific and business approach to align the incentives of its scientific team, collaborators, biotech and pharmaceutical partners and investors to rapidly develop transformative therapeutics for patients in need.• Led activities including process development, analytical methods development, formulations development, process scale-up, manufacturing, quality assurance, and preparation of regulatory filings.• Focused on the development of platform processes to deliver rapid results, high yields, and high-quality products.• Developed consistently high titer CHO cell culture processes (> 3 g/L), efficient and high yield purification processes (> 50% recovery), and stable formulations (> 3 years shelf life).• Produced materials for GLP toxicology studies, successfully transferred processes to contract manufacturing organizations, and oversaw manufacture of GMP materials for clinical trials.• Successfully contributed to regulatory filings resulting in four successful IND applications with unique products and their satisfactory performance in the clinic.• Optimized the test methods and production processes for products in clinical trials to prepare them for production of drug products for Phase 2/3 clinical trials.

Sutro develops best-in-class antibody drug conjugates and multi-specific antibody based drugs for cancer therapy using its cell free protein synthesis technology, Xpress CF™• Conceived, designed, and tested an innovative fermentation process that improved volumetric productivities by a factor of 20 for Sutro’s limiting manufacturing reagent, cell free extract, thereby extending the usefulness of the company’s existing manufacturing facility and saving the company $130 million• Worked with a multifunctional team to redesign Sutro’s GMP manufacturing facility and implement its renovation• Improved key downstream manufacturing operations to double product recoveries and simultaneously double cell free extract activity• Analyzed Sutro’s manufacturing and process development operations and automated key steps to significantly boost productivity, thereby decreasing the number of new hires• Completed development of platform purification processes to improve process robustness, speed development of new molecular entities, and facilitate transfer of processes to Manufacturing

Ambrx is working with an expanded genetic code to incorporate unnatural amino acids into proteins to engineer them for improved pharmacologyLed teams of up to 50 people developing fundamental protein expression and purification processes and novel therapeutic products• Cloned, expressed, purified, and characterized new product targets for timely screening and selection of best variants for further development, including production of milligram quantities for in vitro assays and up to multi-gram quantities for in vivo pre-clinical testing• Scaled-up the fermentation and primary recovery processes for drug candidates undergoing clinical drug substance manufacturing• Developed high titer antibody fragment fermentation processes, increasing volumetric productivities by over 100 fold• Developed low cost, high throughput, and high volume transient transfection processes for CHO cell production of protein candidates, saving the company hundreds of thousands of dollars annually compared to alternative processes• Led two high priority Ambrx product development programs, including one partnered with a prominent pharmaceutical company, resulting in the identification of clinical candidates and on schedule go/no go decisions• Received inaugural managerial award for milestone achievements in product developments and collaborations (2009)• Developed Ambrx’s core technology and increased fermentation yields over 1,000 fold• Scaled-up the process technology and transferred it to contract manufacturing organizations (CMOs) for phase I/II and phase III manufacturing campaigns, leading to production of drug products safely tested in clinical trials• Received inaugural technical award for breakthroughs in scientific technology innovations (2004)

GenWay is a protein, antibody, and ELISA solutions provider• Organized, coordinated, and improved the company’s core IgY (chicken) antibody production processes, enabling high throughput production of clones, antigens, and antibodies• Identified and implemented new technologies and designed and reviewed experiments to streamline operations of each functional area• Standardized operating procedures, implemented project management systems, and developed tools to facilitate transition of work between functional areas, resulting in large (several fold) productivity increases based on both total output and on a per FTP basis• Organized and managed GenWay’s laboratory facilities• Identified, inspected, and procured laboratory equipment, identifying used equipment when available and saving the company hundreds of thousands of dollars• Advertised, screened, interviewed, and hired laboratory personnel• Managed strategic business development, including execution of collaborative studies• Managed both internal and external contract operations

EGen was incorporated to develop generic and follow-on biologics for world markets• Conceived and co-founded business• Served as needed as Chief Financial Officer, Corporate Secretary, and Human Resources Manager, leading to efficient and low cost operations• Formulated key business strategies and authored several versions of the EGen business plan, leading to the targeted sale of the company in 2000• Designed and managed the organization and operation of EGen’s U.S. laboratory facilities, resulting in successful development of multiple pharmaceutical products• Directed development of EGen’s process technologies producing three recombinant products• Resolved difficult scale-up problems that limited final yields and purities, clearing the way for clinical manufacturing• Played major role in production of clinical materials, including development of formulations and lyophilization processes• Implemented and maintained EGen’s QA systems• Initiated and completed conceptual designs for manufacturing facilities to produce biopharmaceuticals, including process flow diagrams, material balances, equipment costs, fixed capital estimates, labor projections, raw material costs, consumable costs, waste treatment costs, overall annual operating costs, profitability analyses, and cash flow analyses• Generated facility designs for a range of plant production capacities, enabling elucidation of the economies of scale

• Designed, developed, and operated high cell density fermentation processes with the versatility to manufacture over 20 protein pharmaceutical candidates in E. coli• Increased fermentation yields 40 fold during tenure, making large-scale production of lead constructs possible• Headed cGMP fermentations of PRIZM's lead drug candidate, rFGF-SAP• Trained personnel to operate cGMP fermentations that smoothly, consistently, and successfully generated clinical grade material• Completed training courses on regulatory affairs in the biotechnology industry• Prepared cGMP documents, including batch records and standard operating procedures• Developed and tested slow release device designed specifically for rFGF-SAP to gradually release 80 percent of the drug during the first month of use

Operations, project management, drug development, biopharmaceutical, bioprocess development, process development, process design, process improvement, protein expression, product development, recombinant protein, fermentation, fermentor, bioreactor, wave, single-use technology, cell culture, DNA, protein refolding, inclusion body, Escherichia coli, E. coli, chinese hamster ovary cells, CHO, HEK293 cells, transient transfection, dhfr, GS, high cell density, centrifugation, dead-end filtration, virus clearance, ultrafiltration, diafiltration, antibody, antibody drug conjugate, ADC, antibody fragment, monoclonal antibody, mAb, antibody fragment, scFv, Fab, human growth hormone, hGH, IgG, antibodies, oncology, cardiovascular disease, FDA, MHRA, NMPA, cGMP, EMA, CMC, contract manufacturing organization, CMO, CDMO, contract research organization, CRO, bulk drug substance, drug product, clinical studies, chemistry manufacturing and controls, CMC