Meaningful work performed by inspired and passionate people.

founders.

Innovation Leaders.

More than 90 years combined experience leading innovation in biotechnology.

James N. Thomas, Ph.D.

Chief Executive Officer
Founding Partner

Victor P. Fung, MBA

Chief Operating Officer
Founding Partner

Dean K. Pettit, Ph.D.

Chief Scientific Officer
Founding Partner

Yining Zhao, Ph.D., MBA

Founding Partner

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.

Click here to learn more

During his many years of experience at Immunex, Amgen, and Just Biotherapeutics he has led efforts to engineer protein therapeutics, invented novel therapeutic modalities and computational methods for therapeutic design, and developed computational and experimental approaches to understanding and controlling biophysical properties of biological macromolecules. Randy has made significant contributions in antibody design, epitope mapping, molecular assessment, stability engineering, construct design, protein structure analysis, and protein engineering. At Just Randy leads the Molecular Design team, integrating molecular design strategies into the entire therapeutic pipeline.

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.

Click here to learn more

He has been an author of numerous regulatory filings to the FDA, EMA, PMDA and many other agencies. With pivotal, commercial, and post-launch filings, these included a heavy emphasis on establishing comparability or biosimilarity for numerous molecules. Randal’s interaction with regulators includes both written and face-to-face meetings with multiple agencies. Randal received his Ph.D. from the University of Colorado in Biochemistry with a focus on membrane protein biochemistry and biophysics, and completed a postdoctoral fellowship at the California Institute of Technology in X-ray crystallography of ion channels.

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®.

Click here to learn more

His work on large and small volume parenteral formulations included monoclonal antibodies, antibody drug conjugates, PEGylated proteins, glycosylated and non-glycosylated proteins and viruses. Bruce was also intimately involved with alternative drug delivery systems at Amgen such as slow release and nanoparticle formulations. He has over 50 research publications relating to protein science and formulation development, is an inventor on multiple patents and holds an adjunct appointment as an Associate Professor on the faculty of the School of Pharmaceutical Chemistry at the University of Kansas.

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. 

Click here to learn more

Mike was also the Technology Team Leader and an architect of Amgen’s Manufacturing of the Future (MoF) initiative that enabled highly productive and cost-effective biologics manufacturing. His team successfully identified, operationalized, and implemented disruptive technologies to a network of pilot, clinical, and commercial facilities. As a Principal Scientist, Mike managed several cross-functional first-in-human and commercial process development molecule teams, aggressively moving them towards IND filings and CMC regulatory submissions. He was also the Enbrel Upstream Scientific Lead responsible for technical activities related to process improvements, second-generation process development, characterization, validation, process transfer, and technical support for commercial production facilities. Prior to Amgen, Mike worked for 8 years at ICOS Corporation where he was accountable for managing Cell Culture and Microbial Clinical Manufacturing and Cell Culture Process Development. Early in his career, he held Production Manager and Research Associate positions at Scantibodies Laboratories and Ultra Diagnostics, respectively. Mike received his Bachelor of Science in Microbiology from the University of Washington. He is also a Registered Microbiologist (R.M.) with the American Academy of Microbiology in Research & Developmental Microbiology.

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

Click here to learn more

In addition to Helix, Brian managed the expansion and renovation of numerous Amgen bulk protein manufacturing and fill-finish facilities in Ireland, Puerto Rico and across the US. Prior to Amgen, Brian worked as a consulting engineer for Jacobs Engineering, where he led the Mechanical Engineering department for Seattle. Brian received his BS in Mechanical Engineering from the University of Washington and his MBA in Project and Construction Management from Golden Gate University in San Francisco. He is a Registered Professional Engineer in the State of Washington.
 

nerve center.

Knowledge & Experience.

Over 70 years combined experience in life science and business administration.

Vasant Gandhi, J.D., Ph.D.

VP of Corporate Development

Debbie Banner

Chief of Staff

Caren Tidwell, Ph.D.

VP of Operations

Suzanne Jones, MBA

Controller

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.