Jim is leveraging his extensive experience in biotechnology and scientific leadership to help create global patient access to vital medicines through technological innovation.
In his current role at Just-Evotec Biologics, Jim is helping to build biologics capability into the broader offering and capabilities of Evotec SE. Jim served as CEO and founding partner of Just Biotherapeutics. Prior to Just, 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. 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.
Linda brings over 20 years of biologics drug development experience to Just – Evotec Biologics that includes executive level accountability for preclinical, clinical, and regulatory functions as well as business development and portfolio management activities. In her current role as SVP Business Development, Linda creates innovative business strategies to further Just’s revenue goals. She also cultivates new clients for the company’s discovery, development, and CDMO partnership programs. Prior to joining Just, Linda served as CEO of two small start-ups and was the President of ProFibrix, Inc., overseeing US-based biologics drug development activities as well as its operations.
Linda has also worked at Genetech and ZymoGentics/BMS overseeing biologics development activities and contributed significantly to the approvals and commercialization of Raplixa (US & EU), Recothrom, and Raptiva and the filing many INDs in the areas of autoimmunity, hemostasis, and oncology. Linda received her Ph.D. in immunology from the University of Chicago and has an expertise in the regulatory aspects of the immunogenicity of biotherapeutics.
Sundar brings over 20 years of broad biotechnology experience to Just – Evotec Biologics that includes biopharmaceutical drug development, operations, clinical and commercial strategy, policy and regulatory affairs. In his current role at Just, Sundar oversees our alliance and program management and business operations functions.
Prior to joining Just, Sundar was the Head of Global Regulatory Affairs at Biocon Biologics and was responsible for accelerating the pipeline toward successful registrations as well as advancing innovative regulatory policies, globally. Prior to Biocon, Sundar worked at Amgen and was responsible for its international regulatory strategy and policy for biologics and biosimilars, and helped shaped biosimilar standards globally. He has successfully led teams in the development of biopharmaceutical drug candidates from the early stages through commercialization, and life-cycle management across multiple therapeutic areas. Sundar, a Chemical Engineer by training; holds a Ph.D. in Bioengineering from Oregon State University and MBA from the University of Michigan.
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.
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.
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. 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.
Mike has over 30 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.
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.
As VP of Quality at Just, Donna is responsible for building and managing efficient and phase appropriate quality systems. Donna brings more than 30 years of experience in biotechnology disciplines, including biologics manufacturing, diagnostics, medical devices, and advanced cellular therapies.
Donna has held numerous Director level roles in Quality Control, Quality Assurance, and Regulatory Affairs. Most recently, Donna served at Dendreon where she supported QA, QC, Operations, and the pre-approval inspection for the first FDA licensed cellular therapy Provenge. Prior to Dendreon, Donna led the QC group at Immunex through the FDA inspection and commercialization of Leukine®. Donna began her career in QC at Genetic Systems with the commercialization of the first HIV blood screening test. Throughout the course of her career, Donna has been actively involved in regulatory inspections, contract manufacturing, pre-approval inspections, and the advancement of numerous products from clinical programs to commercial products.
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.
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.
As VP of Manufacturing Operations at Just – Evotec Biologics Renae is leading the start-up of our new late-stage clinical and cGMP commercial J.POD® manufacturing facility coming on-line in 2021.
Renae is a Biotechnology Operations leader with over 29 years of end-to-end GMP manufacturing, supply chain, and facilities global management experience that spans plant start-up to clinical and commercial manufacturing of biologics in multi-product/multi-host facilities (mammalian and microbial), pharmaceuticals, and medical devices. Throughout her career, Renae has successfully led several successful New Product Introductions, technology transfers, changeovers, start-ups, turn-arounds, and plant shutdowns/site closures for Amgen, Inc., Protein Design Labs, Smith & Nephew and, most recently, Thermo-Fisher (Patheon). This includes GMP manufacturing of cell banks, API’s, bulk drug substance, and finished drug product.
She maintains a strong focus on operational sustainability/business continuity, high success rates, and operational excellence having experience working on various lean initiatives. In addition, Renae is considered an industry expert on aseptic technique, aseptic processing, contamination control, and GMP compliance having inspection experience with various regulatory agencies – domestic and international.
Renae received her Bachelor of Science degree in Math/Science and Athletic Training from the University of Mary. Renae was an Academic All-American National Scholar Athlete and was inducted into the University of Mary Hall of Fame.
Caroline Chan joined Just in September 2016 as the VP of Human Resources. Bringing over 20 years of experience in biotechnology and healthcare industries, Caroline has held numerous HR leadership, business partner and merger & acquisition roles throughout her career. Most recently, Caroline was the Head of Human Resources for Onyx Pharmaceuticals, which was acquired by Amgen in 2013. Prior to Onyx, she supported numerous senior executives and business functions at Amgen and served as HR Lead for Amgen’s North American R&D sites. During her time at Amgen, she also held various roles in Compensation and HR Operations. Previously, Caroline led the compensation and stock administration functions for Immunex Corporation. She began her career at Group Health Cooperative. Caroline earned a bachelor’s degree in Psychology from Smith College.
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.