Meaningful work performed by inspired and passionate people.
More than 90 years combined experience leading innovation in biotechnology.
As a founding partner and CEO, Jim is leveraging his extensive experience in biotechnology and scientific leadership to deliver the mission of Just. Over the course of his career, Jim’s passion has been to provide vital medicines to patients, and his vision for Just expands this to include patients worldwide.
Previously, Jim served as vice president of Process and Product Development within the Translational Sciences R&D organization at Amgen. In this role, he led the development and application of all process, analytical and formulation technologies used to manufacture both clinical and commercial large molecule products. He retired from Amgen in May of 2014 to found Just. Jim was first exposed to biotechnology as a postdoctoral fellow at MIT almost 35 years ago, then worked as a scientist and leader at Genentech, Immunex and Amgen. Over the course of his career, he has contributed to the advancement of many important therapeutics including Activase®, Vectibix®, Enbrel®, Prolia®/Xgeva® and Repatha™. Jim has built teams, departments and functions passionate about creating and using innovative technologies to deliver to the needs of patients, and he and his team at Just are continuing this important mission.
As founding partner and COO of Just, Victor brings over 30 years of biotechnology industry experience that includes executive level accountability for biopharmaceutical process development, manufacturing and operations.
During his tenure at Amgen, Victor was site head for Process and Analytical Sciences in Seattle, Washington and global leader for Pilot Plant Operations and Cellular Resources across three locations. He managed diverse scientific disciplines such as cell culture process development, purification process development, analytical sciences, pilot plant operations, cell banking, nucleic acid chemistry, bioassay, biosafety and critical reagents. Victor worked at Genentech Inc., Immunex Corporation and Targeted Genetics and has contributed to the commercialization of biopharmaceuticals such as Activase®, Pulmozyme®, Enbrel® and Vectibix®. In his most recent position, Victor was accountable for the development and commercialization of Amgen’s biosimilars portfolio. Victor was called upon to lead technology and business initiatives that transformed how molecules were designed and manufactured. He helped to create process development capabilities for the newly formed Biosimilars business unit within Amgen. These responsibilities reinforced the importance of developing strong strategic partnerships both internally and externally. Partnerships will be critical and foundational to success.
As founding partner and CSO at Just, Dean brings a broad scientific background, and a deep commitment to advancing innovative technologies and challenging the industry to improve worldwide access to protein therapeutics.
Over his career, Dean has held numerous leadership roles in process development functions at Immunex and Amgen, including Drug Delivery, Formulation, Analytical and Formulation Sciences. Most recently, Dean served as Executive Director of Drug Substance Development at Amgen, responsible for Cell Culture and Cell Line Development, Purification, Analytical, and Bio-characterization functions. While at Amgen, Dean played a key role in the development of a concept known as Product Attribute Control (PAC) that aims to actively measure the attributes of biopharmaceuticals during manufacturing and provide real time process control. This concept has led to the development of novel processing and analytical technologies which will drive an improvement in product quality and a reduction in the cost associated with product release testing in the biopharmaceutical industry. Dean began his career working with medical devices at Allergan and then earned his Ph.D. and completed a postdoctoral fellowship in Protein Engineering at the University of Washington Department of Bioengineering.
Dr. Yining Zhao is currently a founding partner at Just. He brings his 17 years’ biopharmaceutical experience in the areas of Strategy Management, Business Development, Product Development and M&A. Dr. Zhao started his pharmaceutical career at Amgen in 1999, then joined Pfizer in 2004 and returned to Amgen in 2012. He was Executive Strategy Director at Global Commercial Operations of Amgen based in Thousand Oaks, California where he was leading the market entry strategy, business development and commercialization of biosimilars in 20 countries outside US and EU. When at Pfizer, he was the Asia Strategy Lead overseeing the Asia strategy across small molecule, biologics and vaccine. He had also served as the interim head of Pfizer’s Bio-enhancement Development Unit during 2009-2010 in charge of the biosimilar and biobetter strategy development and business operation.
Dr. Zhao received his B.S. in Pharmaceutical Sciences from Fudan University (Shanghai, China), Ph.D. magna cum laude in Analytical Chemistry from Ghent University (Ghent, Belgium), and MBA from Massachusetts Institute of Technology (Cambridge, USA). Yining has contributed more than 30 peer-reviewed publications and book chapters.
“At Just. we will design solutions for patients worldwide, developing technologies and products where barriers to access, like cost, are significantly diminished.”
– Jim Thomas
scientific leadership team.
Integrating Molecular, Process, Product & Plant Design.
More than 80 years of combined experience working across the spectrum of technologies used to discover, develop and manufacture biologics.
Randal R. Ketchem, Ph.D. | VP of Molecular Design
Dr. Randal Ketchem received his Ph.D. in Molecular Biophysics from The Florida State University, focusing on experimental protein structure determination, resulting in the first membrane-bound protein structure solved by Solid State NMR. As part of this effort he developed computational methods for the structure calculation and refinement of membrane-bound proteins. Randy continued his training in structural biology in a postdoctoral fellowship at The Scripps Research Institute where he expanded his experimental and computational efforts into solution-based protein structure. Randy then joined Immunex in 1997 to apply his expertise in protein structure modeling and analysis to efforts in the development of biologic-based therapeutics.
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Randal Bass, Ph.D. | VP of Process Design
Dr. Randal Bass is responsible for upstream, downstream and analytical development activities at Just. Randal began his 12+ year career in industry at Amgen, joining the Analytical Sciences department, where he led analytical and cross-functional process teams. Most recently, Randal served as a director of Process Development overseeing the Washington site Analytical Sciences function. Randal has broad experience developing large molecule therapeutics, both novel and biosimilars, from early stage First in Human, to commercialization through post-launch support and second generation commercial processes.
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Bruce Kerwin, Ph.D. | VP of Drug Product Design
Dr. Bruce Kerwin is responsible for all aspects of Drug Product Design at Just including development of our high throughput biophysical characterization platform, formulation platform, and commercial drug product. Dr. Kerwin has worked in the biotechnology industry for more than 20 years and is a recognized expert in protein formulation and drug product development. In prior roles at Amgen he led numerous project teams developing novel solutions to formulation problems such as high viscosity, high concentration and protein aggregation. He contributed to numerous programs that successfully brought drug candidates through development with contributions to commercialized biopharmaceuticals such as Aranesp®, Vectibix®, Imlygic™ and Kineret®.
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Michael W. Vandiver | VP of Manufacturing & Plant Design
Mike has over 27 years of biopharmaceutical process development and manufacturing experience that includes 14 years at Amgen in Principal Scientist and Director level roles. Prior to Just, Mike was the Director of Pilot Plant Operations at Amgen. His responsibilities included the management and operational oversight of upstream, downstream, and plant automation/engineering activities for the pilot-scale production (2kL) of early and late stage molecules. During Mike’s tenure, plant success rates were >95% for nine consecutive years while increasing run rate, plant utilization, and decreasing headcount.
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Brian Horman, P.E. | VP of Facilities & Engineering
Brian brings over 36 years of biologic laboratory and facility design and construction experience to Just. He has led multi-million dollar capital development projects across North America and internationally. Brian joined Just from Vulcan Inc. where he led the development of the Allen Institute for Brain Science laboratory and managed capital projects for the Allen Institute for Artificial Intelligence and the University of Washington School of Medicine. Prior to Vulcan, Brian served as the Director of Capital Projects for Amgen where he led the development of the Helix campus in Seattle – a 900,000 sf greenfield research and development campus that included base-isolated laboratories for discovery research, tissue culture, cell biology, and process development.
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Knowledge & Experience.
Over 70 years combined experience in life science and business administration.
Vasant Gandhi, J.D., Ph.D.
VP of Corporate Development
Chief of Staff
Caren Tidwell, Ph.D.
VP of Operations
Suzanne Jones, MBA
Dr. Vasant Gandhi is responsible for corporate development at Just. Vasant has broad experience in life sciences transactions and strategy through corporate development (licensing, technology transfer and strategy), alliance management, and commercial and development operations.
He has worked on commercial strategy and deals for therapeutics (including biosimilars), diagnostics, and vaccines. Vasant has worked at the NIH/NCI, Immunex, Amgen, Abraxis Bioscience, and for biotechnology and pharmaceutical companies through his consulting activities. Vasant holds advanced degrees in science, law, and business.
Debbie joined Just at its inception and is responsible for implementing executive strategy, facilitating connections between company stakeholders and managing communications for Just. Debbie has been active in the biotechnology industry in various roles for over 16 years. Most recently, she was a specialist business analyst at Amgen, where she was responsible for communications, management of the leadership team and technology development programs for the Process & Product Development organization. Prior to its purchase by Amgen, Debbie began her biotech experience in Regulatory Affairs at Immunex Corporation during the Enbrel® BLA approval and launch, where she helped to register process improvements and new manufacturing facilities to ensure patient Enbrel supply. Debbie earned a B.A. in Communications from Cleveland State University with significant coursework from Kent State University. Before joining the biotechnology industry, Debbie worked in corporate advertising and taught internationally.
Dr. Caren Tidwell joined Just at its inception and brings over 30 years of academic and industrial bioengineering experience to the company. Prior to joining Just, she directed operations of the University of Washington Engineered Biomaterials Industry Consortium. Caren has held several scientific management positions during her 15-year tenure at the UW, including Scientific Research Manager and Recharge Center Manager for the NSF Engineered Biomaterials Engineering Research Center. Caren has extensive experience in strategic planning, research operations, biomaterial/medical device research and development, and grants management. Caren has managed numerous complex, multi-investigator, multi-institutional research grant proposals to governmental and non-profit agencies, biotech/biomedical corporations, and private foundations. Prior to graduate studies, Caren worked for Shiley, Inc. (division of Pfizer) as a project engineer responsible for bioprosthetic heart valve research and development. Caren received her B.S. in Chemical Engineering from UCLA, and her M.S.E. and Ph.D. in Bioengineering from the University of Washington.
Suzanne oversees the financial and resource management infrastructure for Just. She is responsible for budget and forecasting activities, cash flow management and reporting on the financial health of the company. Until recently, Suzanne was at Amgen as the Director of Process & Product Development, Business & Resource Management. She began her career at Amgen 15 years ago in Clinical Operations where she helped define the first resource forecasting process for clinical studies. Suzanne then transferred into the Process & Product Development organization, where she directed the business and resource management team responsible for budgeting, FTE forecasting, project scheduling and project time tracking. Prior to Amgen, Suzanne worked for TRW Systems and Information Technology Group as a business consultant where she performed process analysis, process redesign and end user training for large data management systems for state and local governments. Suzanne holds a Master of Business Administration from the University of Phoenix and both a Bachelor of University Studies and a Training and Learning Technologies Certificate from the University of New Mexico.