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. 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 Genentech and ZymoGenetics/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.
Christelle has over 20 years of international business development and marketing experience in the life sciences and biologics CDMO industry. In her current role as SVP Business Development, Christelle leads the global Business Development team, with a focus on shaping innovative business strategies, building a strong industry presence and establishing Just – Evotec Biologics as a global leader in the AI-driven discovery to continuous manufacturing space. Prior to joining Just – Evotec Biologics, Christelle held several senior Business Development roles at Catalent where she supported the growth of the biologics division in Europe and led the European Cell Therapy Business Development team. Christelle also served as Head of Marketing and Sales at PX’Therapeutics, a French biologics CDMO and brings in an expert knowledge of the biotherapeutics and biosimilars markets, a passion for building strategic partnerships as well as strong Business Development culture and best practices.
Christelle received her Ph.D. in Organic Chemistry from the University of Grenoble, France and also holds a master in Technology & Business Management.
Dr. Randal Ketchem received his Ph.D. in Molecular Biophysics from 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, Just Biotherapeutics, and Just – Evotec Biologics 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 J.MD, incorporating biologics design and optimization, informatics development, Data Science, and J.HAL antibody discovery.
Dr. Randal Bass is responsible for upstream, downstream, analytical development activities, and J.POD manufacturing operations at Just – Evotec Biologics. Randal began his 20+ 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.
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.
Ben brings over 25 years of biotechnology industry experience to the Just – Evotec Biologics team. As SVP of Manufacturing Operations and Site Head at Just, Ben oversees Clinical and Commercial Manufacturing Operations, Facilities and Engineering, and Supply Chain teams for J.POD Redmond, Washington (US), J.POD Toulouse, France (EU), and J.PLANT Operations in Seattle, Washington. Prior to joining the team, Ben led operations and technical teams at several leading biopharma companies including BioMarin, Amgen, Shire, Genzyme, Kite, and Resilience. Ben received his BS in Cell and Molecular Biology from Cal Poly Pomona.
Lisa brings over 20 years of experience in CMC process development to Just – Evotec Biologics, working on a broad range of large molecule biotherapeutics at early and late stages of development. She currently leads the Process and Product Design functions, an innovative team of scientists and engineers design cell lines, media, bioreactor and purification processes, analytics, drug product and automation for integrated, continuous manufacturing operations, across Just – Evotec Biologics’ Seattle, Redmond, and Toulouse sites.
Prior to Just, Lisa spent 12 years at Amgen as a downstream group leader, with expertise in downstream process development and scale-up, batch and multi-column chromatography, high throughput resin screening, and viral clearance strategies. Additionally, she has been a CMC process team leader for several early and late stage monoclonal antibody, Fc fusion and biosimilar products. She has authored multiple regulatory filings for different jurisdictions and participated in face-to-face interactions with the FDA. Lisa received her Ph.D. in Biochemistry from Baylor College of Medicine in Houston TX, with a focus on the activity and regulation of cyclin-dependent kinases. She also completed a post-doc at Fred Hutchinson Cancer Research Center in Seattle, WA researching the role of cyclin dependent kinases in fruit fly nervous system development.
Magnus Schroeder joined Just-Evotec Biologics in August 2021 as VP Process and Product Design. He is leading the P&PD team at the Redmond JPOD site facilitating FIH, commercialization and technology development, and evaluation projects. Magnus has over 18 years of industry experience in early to late phase process development, CMC strategy, global tech transfer and technology development in the biopharmaceutical industry. Prior to joining Just, he held roles of increasing responsibility at Dynavax Technologies, Inc., CSL Limited, AGC Biologics and Avid Bioservices, Inc.. Magnus has supported the commercial launch of five biopharmaceuticals, a number of commercial processes and numerous IND/IMPD enabling development programs.
Magnus has received his M.S. in Molecular Biotechnology with a focus on mammalian cell culture from the University Bielefeld, Germany and earned his Ph.D. from the Research Center Juelich and University Bielefeld, Germany with a focus on protein purification development. He also conducted post-graduate research at the University of Minnesota and Rensselaer Polytechnic Institute in biochemical engineering and Deakin University, Melbourne, Australia in corporate management.
Eva brings 24 years of biologics development and manufacturing experience to the Just – Evotec Biologics team. Eva currently leads the Technical Operations group for the Seattle and Redmond GMP manufacturing facilities, focusing on the design and implementation of a continuous platform technology from bench to manufacturing scale. Eva built the Technology Operations team to bridge Process Design and Manufacturing Operations; and is comprised of experts in equipment design, process automation, manufacturing execution systems, validation, modeling, process transfer, and includes a J.POD expansion team to support Just – Evotec Biologics’ growing network of J.POD manufacturing facilities worldwide.
Prior to joining Just Biotherapeutics in 2015, Eva held scientific/engineering roles in Cell Culture Process Development at Merck & Co., and Purification Process Development at Immunex and Amgen. Eva has downstream expertise in filtration, viral clearance, chromatography, and process modeling. Additionally, she has served as CMC Process Team Lead for a late-stage program and continuous process technology implementation. Eva has authored multiple publications, contributed to numerous regulatory filings, and is a named inventor on multiple patents. Eva earned a B.S. in Chemical Engineering from the University of Minnesota.
Valerie brings over 25 years of biotechnology industry experience to the Just – Evotec Biologics team. As VP of Capital Projects at Just, Valerie oversees the planning, design, development, and implementation of all of Just’s capital facilities and projects, including the build of Just’s current and future J.POD facilities. Prior to joining the team, Valerie has delivered multiple international projects for several leading biopharma companies including Amgen, Bristol Myers Squibb, and Merck.
Valerie received her BS in Mechanical Engineering from the Polytechnic University of Puerto Rico.
Dr. Caren Tidwell joined Just at its inception and brings over 30 years of academic and industrial experience to the company. Prior to joining Just, she directed operations at the University of Washington Engineered Biomaterials Industry Consortium. Caren has extensive experience in strategic planning, business and research operations, governmental, commercial and non-profit program management. Dr. Tidwell leads Just’s governmental alliance and program management efforts and has managed numerous complex, multi-investigator, multi-institutional programs with governmental and non-profit agencies, biotech corporations, and private foundations. 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.
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.