About Us
KBI Biopharma is an award-winning biopharmaceutical contract services organization providing fully-integrated, accelerated drug development and biomanufacturing services to pharmaceutical and biotechnology companies globally.
With each of our 500+ client partners, we have worked closely to personalize and rapidly accelerate their drug development programs. Built upon a foundation of world-class analytical capabilities, we deliver efficient process development and clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs.
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We are analytics-driven,
technical problem-solvers
who have dedicated our lives
to developing biologics.
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Our Leadership
Dirk Lange
President and CEO
Dirk Lange began serving as President and CEO of KBI Biopharma in February of 2020. Prior to being appointed President and CEO, Dirk served as KBI’s Chief Operating Officer. His previous roles at KBI include Senior Vice President of Operations and Site Head in Boulder, CO as well as Vice President positions in Operations and Business Development. Before returning to the US in 2016,Dirk was Head of External Supply Operations at Novartis Biologics in Basel, Switzerland and held leadership positions in Operations, Program Management, and Business Development at Sandoz Oncology Injectables in Austria, and Rentschler Biopharma in Germany. Dirk has extensive experience in technical operations, quality remediation, supply chain, and third-party operations. Dirk has also led several Drug Substance and Drug Product Sites through successful Health Authority inspections including FDA, EMA and ANVISA. Dirk received his Master Professional (CCI) of Technical Management in 2005 and his Bachelor Professional (CCI) of Pharmaceutical Technology in 2002. Dirk also taught Economics and Operations Management at Chamber of Commerce and Industry in Ulm, Germany.
Doris Michor
Chief Operating Officer
Doris Michor
Chief Operating Officer
With more than 22 years of experience in operations, quality assurance, and commercialization, Doris Michor serves as Chief Operating Officer of KBI Biopharma. Doris joined KBI in 2018 as VP, Manufacturing Operations and served as Senior VP, Manufacturing Operations and Site Head Boulder before stepping into the Executive Vice President, Operations role in 2020. Prior to joining KBI, Doris served as Director, Supplier Relationship Management at Novartis Biologics where she was responsible for their US based licensing partners and their US CMO partners. In this role, she built and led a group responsible for all technical, quality and supply chain aspects of Novartis’ Drug Substance and Drug Product portfolio. Doris has also held leadership positions at Sandoz Oncology Injectables in Austria and Ever Neuro Pharma. Doris holds a Master’s degree in Microbiology from Karl-Franzens-University in Graz, Austria and a degree as Qualified Person from the University of Vienna, Austria. Most recently, Doris completed her MBA with Middlesex University in London.
Stewart McNaull, Ph.D.
Senior VP, Business Development
Stewart McNaull, Ph.D.
Senior VP, Business Development
Stewart has nearly 20 years of experience in biopharmaceutical process development and manufacturing with a focus towards driving technology innovation to the manufacturing floor. He has led upstream process development and cGMP manufacturing groups, managing clinical and commercial program supply. Stewart has been a leader in the evaluation of single-use technologies and has played a key role in the design and implementation of five cGMP single-use manufacturing streams globally. He has designed several innovation initiatives, including development of new technical offerings for sales and marketing launch. Stewart maintains a strong industry presence by presenting at major conferences and as a steering committee member of the BPOG industry consortium for Technology Roadmapping. His previous experience includes technical roles at Bayer Biologics, followed by 15 years of biopharma CDMO technical and management experience. Stewart earned his Ph.D. in Chemical Engineering/Bioengineering at Georgia Institute of Technology.
Rachel Mandell
VP and General Counsel
Rachel has over 25 years of experience as a corporate attorney. In her previous role as Director, Legal at Lord Corporation, Rachel advised the business on commercial matters, provided primary support to the finance and M&A teams, and provided legal support to Lord’s subsidiaries around the world. She has extensive experience with cross border transactions, human resources and data privacy issues. Rachel has represented pharmaceutical companies on a wide range of issues as in house counsel and as outside counsel in connection with public offerings. She has negotiated private placements, clinical trial agreements, licensing arrangements and manufacturing agreements. Ms. Mandell worked at the start of her career with the firm that is now DLA Piper in its Baltimore office focusing on public offerings, private placements and mergers and acquisitions. Ms. Mandell has a BA from Duke University and a JD from the University of Maryland.
Bob Todd, Ph.D.
Senior VP, Technology & Innovation
Bob Todd, Ph.D.
Senior VP, Technology & Innovation
Bob has over 25 years of experience in the development of processes for biotherapeutic products and serves as KBI's Senior VP of Technology and Innovation. Prior to joining KBI, Bob was a Director of Process Development at Amgen, responsible for developing advanced process modeling capabilities as well as implementing a global process technology platform for the production of monoclonal antibodies. With experience on over 20 different clinical and commercial development programs, Bob has gained experience with early and late stage process development activities for both fermentation and cell culture processes. Bob received his Ph.D. in Chemical Engineering from the California Institute of Technology and his B.S. in Chemical Engineering from the University of Michigan.
Glenn Barbrey
Senior VP, Quality & Regulatory
Glenn Barbrey
Senior VP, Quality & Regulatory
Glenn joined the organization in December 2020 as VP of Global Compliance and Quality Systems. Glenn brings more than 30 years of Biotech, Pharmaceutical, and Medical Device experience to KBI and he has held positions of increasing responsibility that spans Quality Assurance, Quality Control, Technical Operations, and Consulting.
Glenn has provided leadership to the Global Quality organization and has been instrumental in delivering our FDA commitments at the Hamlin Rd site. Glenn has also made key hires on the Global team which position us to continue to meet our internal, client, and regulators’ expectations.
Glenn’s background and experience are an excellent fit to lead our Quality organization as he has demonstrated technical and strategic leadership across multiple domestic and international assignments.
- Led a change initiative to create a speak up culture of empowered professionals
- Responsible for Quality System implementation and facility licensure at a $1B green field cell culture facility
- Led multiple successful Health Authority Inspections with FDA, ANVISA, MFDS, TGA, MHRA
- Led a Quality Assurance organization for a CDMO that produced fermentation and cell culture products for commercial and clinical programs
- Started a compliance consulting practice which grew to over 100 professionals in 8 years
- Head of Quality for the integration of two companies that consisted of 50 applications and the harmonization of business and quality processes
- Responsible for developing and implementing an integrated commissioning and qualification program across 21 sites globally
Glenn holds a BS in Microbiology from Clemson University and an MBA from The Citadel.
Joint Scientific Advisory Board
Formed to foster innovation in technology platforms used to bring complex molecules to clinic and ultimately to market, the JSAB offers unparalleled scientific and business expertise with three notable appointments: John F. Carpenter, Ph.D., Steven M. Cramer, Ph.D., and Michael J. Betenbaugh, Ph.D.
Our JSAB appointed members are experts in gene expression, cell line development, protein purification, analytics, and development of monoclonal antibodies and therapeutic proteins.
Appointed Members
John F. Carpenter, Ph.D.
Dr. Carpenter is Professor of Pharmaceutical Sciences at the University of Colorado School of Pharmacy, and a co-founder and co-director of the University of Colorado Center for Pharmaceutical Biotechnology. His research interests include mechanisms for protein degradation and stabilization in pharmaceutical formulations during bioprocessing and in delivery systems. Also, he has worked for several years to define rational strategies for stabilizing proteins and vaccines during freeze-drying and storage in the dried solid. He has published more than 280 peer-reviewed papers and is an inventor on more than 30 issued patents. He is editor for reviews and commentaries for Journal of Pharmaceutical Sciences. Dr. Carpenter serves on the editorial advisory boards for Pharmaceutical Research, The AAPS Journal, Journal of Pharmaceutical Sciences, Current Pharmaceutical Biotechnology, Molecular Pharmaceutics and BioPharm International. He has received several teaching awards and The Ebert Prize. He is a fellow of the American Association for Advancement of Science (AAS), the American Association of Pharmaceutical Scientists (AAPS) and the National Academy of Inventors. He has received the AAPS Research Achievement Award in Biotechnology. Dr. Carpenter also is the organizer of the Colorado Protein Stability Conferences.
Steven M. Cramer, Ph.D.
Dr. Cramer is the William Weightman Walker Professor at Rensselaer Polytechnic Institute and is known for his contributions to the separation of complex biological products and the development of chromatographic materials, processes and predictive tools for enabling their biomanufacturing. In addition, he has made seminal contributions to the molecular understanding of the interactions that create unique selectivities in these separation systems. His lab is currently conducting research on several areas related to protein-surface interactions including prediction of protein binding affinity and multiscale modeling of chromatographic systems, development of efficient antibody and bispecific antibody separation systems, fundamental studies in multimodal chromatography, multilevel automated peptide synthesis/screening system for design of affinity peptides, smart biopolymer affinity precipitation systems, biophysics of protein interactions with surfaces, ligands and proteins, platformable strategies for effective removal of process HCPs and integrated semi-continuous biomanufacturing processes. He was the editor of Separation Science and Technology for 20 years and has been awarded the Alan S. Michaels Award for the Recovery of Biological Products (ACS Division of Biochemical Technology) and the ACS National Award in Separation Science and Technology. He was also awarded Rensselaer’s Early Career Award as well as the School of Engineering Outstanding Professor and Research Excellence Awards. Dr. Cramer has been elected a fellow of the American Association for the Advancement of Science, American Institute of Chemical Engineers, the American Chemical Society and the American Institute for Medical and Biological Engineering.
Michael J. Betenbaugh, Ph.D.
Dr. Betenbaugh, an independent consultant as well as professor of chemical and biomolecular engineering and lead principal investigator of the Advanced Mammalian Biomanufacturing Innovation Center (AMBIC) at Johns Hopkins University, is known for integrating systems biology with cellular, metabolic and biochemical engineering for eukaryotic biotechnology applications. Dr. Betenbaugh is one of the original pioneers of eukaryotic metabolic engineering and has made multiple landmark contributions in improving the efficiency and effectiveness of mammalian and insect production hosts, in fundamental discoveries in glycobiology, in applying systems biology to understand mammalian cells in biotechnology and biomedicine and in advancing knowledge about sustainable algal bioprocessing for biofuels and other products. Dr. Betenbaugh’s most significant achievements include the application of chaperones and foldases to increase protein folding and product yields from insect cells; glycoengineering in insect and mammalian hosts to produce sialylated high-value glycoproteins; anti-apoptosis engineering to increase mammalian survival and productivity; genomics, proteomics, glycomics, and systems biology models of mammalian hosts; microRNA analysis and genome engineering in mammalian cells; and advancing sustainable microalgae processing. Dr. Betenbaugh’s group was the first to undertake whole pathway metabolic engineering to overcome glycosylation bottlenecks in one of the first projects funded as part of National Science Foundation’s Metabolic Engineering Program, a forerunner to current synthetic biology efforts. His group was also one of the first to demonstrate apoptosis activation in industrial cell culture processes and is the world leader in controlling programmed death in cell culture processes. Dr. Betenbaugh received the D.I.C. Wang Award for Excellence in Biochemical Engineering (2017), the Marvin J. Johnson (2015) and James Van Lanen awards from the American Chemical Society’s Division of Biochemical Technology and the Cell Culture Engineering Award (2010). He served as a visiting scientist at the Kyoto Institute of Technology in 2001 and is an elected fellow of the American Institute for Medical and Biological Engineering (AIMBE).
