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

Executive VP, Operations

With more than 22 years of experience in operations, quality assurance, and commercialization, Doris Michor serves as Executive Vice President, Operations 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.

Mark Roche

Senior VP, Quality & Regulatory

Mark Roache began serving as KBI's Senior Vice President, Quality and Regulatory in April 2020 at our Durham, NC location.

Mark was previously Senior Vice President and Chief Quality Officer with AveXis, a gene therapy company owned by Novartis, where he led the Quality group through the successful licensing and commercialization of AveXis first product.  Before joining AveXis, Mark held the position of Head of Quality for biotech manufacturing sites with both Merck and Novartis.  Additionally, he led the business integration project resulting from the sale of Novartis flu vaccines to CSL.

Earlier in his career, Mark held a number of positions of increasing responsibility, with technical and quality leadership roles in small and large molecule pharma and combination products.  These positions included Senior Director of Compliance and Quality Systems at Novartis Diagnostics in Emeryville, CA; Director, Global Quality Management with Bayer Biologics and Director of Validation, also with Bayer.  Over the years, Mark has been active within PDA, and has presented on topics covering continuous process verification, design of experiments and the enabling role of technology in the industry.

Mark holds a Bachelor of Science with honors in Pharmacology from the University of Liverpool, UK, and a Master of Science in Biomolecular Technology from the University of Leicester, UK.

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.

Wayne Yount, Ph.D.

Senior VP, Analytical & Formulation Sciences

Wayne joined KBI in 2005 as a member of the Biopharmaceutical Development team and has played a pivotal role in KBI’s growth over the past 14 years, including leading KBI’s North Carolina laboratory operations teams through several successful FDA pre-approval inspections, EMA inspections, and FDA routine inspections. Wayne oversees analytical and formulation activities across all KBI locations. He has also overseen the development and GMP support of hundreds of clinical stage biologics, and has been associated with the successful formulation development of over 50 clinical and commercial biopharmaceutical products, including liquid and lyophilized dosage forms for intravenous and subcutaneous administration, at protein concentrations ranging from 1mg/mL to 200mg/mL. Prior to joining KBI, Wayne worked in proteomics for Serenex, a small biotech company and obtained his Ph.D. in Chemistry from Duke University.

Louise Hall

VP, Program Management

Louise Hall is Vice President of Program Management at KBI. Louise joins KBI from Locus Biosciences Inc, an RTP start-up with a focus on CRISPR-engineered bacteriophage technology, where she was Vice-President, CMC. In this capacity, Louise built and lead the teams responsible for the development of drug substance and drug product for clinical Phase I trials, and for the build of the GMP facility to support in-house manufacturing. Before joining Locus in 2018, Louise led the Pharmaceutical Development Services site for Patheon Greenville North Carolina where she piloted creation of the steriles flagship development site and oversaw activities supporting a client development portfolio of 150 projects.  Louise previously held Project Management positions for Patheon Canada, and Commercial Operations management roles within Apotex Steriles Division, and McNeil Consumer Healthcare (Johnson & Johnson).  Earlier in her career, Louise was Project Manager for a venture-backed start-up Biologics company.  Louise earned a BSc, specializing in Microbiology, from University of Waterloo and is a certified Project Management Professional (PMP).

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.

Joey McMahon

VP, Impact Investment

Joey and the Impact Team work to help KBI transform drug development and healthcare for patients globally.

Joey's team builds relationships and enables large-scale impact through patient-focused strategy, marketing, and communications. Most recently, they launched an international childhood cancer collaboration with the Coalition Against Childhood Cancer, the Association of Pediatric Hematology Nurses, and the Association of Pediatric Oncology Social Workers.

Joey also founded The Monday Life, a national charity for children’s hospitals, co-founded The Give Gala, an award-winning ‘no-money’ charity event, and has been featured for his impact work by media outlets including the Financial Times, NBC, and CBS.

Joey studied and received his MBA and undergraduate degree from Duke University, where he was also a student manager for Coach K and the Duke Men’s Basketball Team, the Brand Strategist for the Coach K Leadership Center, and the recipient of the Class of 1990 Scholarship for Service.

Dan Povia

VP, Finance

Dan is a seasoned executive with over 30 years of work experience in financial and operational controls, financial reporting and forecasting risk management, audit and compliance. He has developed and executed multiple successful business plans for start-up venture backed companies and facilities. In a previous role as VP of Finance at Eisai Inc., Dan led the transition of the business functions of the multi-billion dollar acquisition to the parent company. He then initiated and implemented procurement practices resulting in significant annual run savings and systemic cultural changes. Dan earned his MBA at Duke University’s Fuqua School of Business having garnered the distinction of a Fuqua Scholar, graduating in the top 10% of his class. He obtained his BS in Economics with a dual major in accounting and decision sciences from the Wharton School, University of Pennsylvania. There he graduated with Cum Laude Honors.

Joe Tetzlaff

VP, Information Technology

Joe is our Vice President of Information Technology where he is responsible for Computer System Validation and Information Technology. Joe has established CSV & IT as an enterprise function for KBI, leading his team to provide consistent service delivery across all KBI sites with a focus on continuous improvement & innovation. Joe’s previous experience includes directing, as CIO, Information Technology for inVentiv Health's Clinical division. Prior to inVentiv Joe was the CIO for Ingenix, a Division of United Health Group. Joe has over 20 years of experience supporting IT in a variety of global companies with over 13 of those years in GxP environments. He earned his MBA in Information Technology & Finance from the STERN Business School of New York University.

Vickie Dowling, Ph.D.

VP, Analytical & Formulation Sciences  |  Boulder, CO

Vickie joined KBI in 2006 in the Biopharmaceutical Development department at the Durham, NC site. During her tenure at the Durham site, she led a project team responsible for analytical method establishment, formulation development, characterization and/or QC support for more than 30 clinical protein therapeutics, including monoclonal antibodies, peptides, enzymes, fusion proteins, recombinant protein vaccines, and PEGylated proteins. Vickie transitioned to the Boulder, CO site to build the Analytical and Formulation Sciences department shortly after KBI’s acquisition of the site in 2014. During her time in Boulder, Vickie has overseen significant growth of the department to enable full onsite analytical support for the microbially-expressed protein therapeutics at the Boulder site, ranging from early phase clinical to commercial products. She also successfully led the team through two FDA pre-approval inspections and an EMA inspection in support of approval of the Boulder site for commercial manufacturing and testing. Vickie received her Ph.D. in Analytical Chemistry from Duke University.

John Gabrielson, Ph.D.

VP, Analytical Sciences & Site Head  |  Lousiville, CO

John has over 14 years of experience developing biologics. Prior to joining KBI, John co-founded Elion Labs in 2015, where as President and CEO, he defined the company’s strategic direction and executed its business plan. 

Prior to Elion, John led an analytical organization at Amgen focused on developing, validating and implementing analytical methods for purity determination, identity confirmation, structural characterization, and comparability testing of biologics from late-stage clinical development through commercialization and post-approval.  Throughout his career, John’s primary focus has been to improve analytical methods, for which he has delivered invited presentations, been issued one patent, and written numerous articles and book chapters.

Brent Kendrick, Ph.D.

VP, Research & Development  |  Louisville, CO

Brent Kendrick received his B.S in Aerospace Engineering and his Ph.D. in Pharmaceutical Sciences from the University of Colorado. Prior to graduate school, Brent was a Surface Warfare Officer in the United States Navy. After joining Amgen in 1997, Brent served as Formulation Team Lead in Pharmaceutics for 2 products: Infergen and a novel thrombolytic enzyme, where he developed a patented lyophilized formulation. He then managed a clinical analytical laboratory team in Quality Control and served as Product Quality Lead for PEG-sTNFr1. In 2002, he joined Process Development and held roles as Analytical Sciences Team Leader for multiple late stage clinical products and Drug Substance Process Team Leader for Nplate from Phase III through Commercial Launch. He led his group at Amgen through multiple successful commercial product approvals (Nplate, Prolia/XGeva, Blincyto and T-Vec), technology transfers, validation campaigns and biosimilarity/comparability studies, as well as leading the creation of cross-functional guidelines on comparability, method development and validation strategy. He was Director of Amgen’s Attribute Sciences for Late Stage Clinical and Commercial Products, leading a team of over 100 staff and multiple sites worldwide. He has been an adjoint and adjunct faculty member at the University of Colorado for over 18 years, teaching a lecture on light scattering biophysics every other year. He taught a semester-long 3 credit hour course on Heat Transfer in the CU Chemical Engineering Department, co-founded Elion, LLC, a contract analytical and formulations laboratory and consulting company for biotechnology product development, and currently serves as Vice President, Research and Development at KBI Biopharma.

Sigma Mostafa, Ph.D.

VP, Process Development  |   RTP, NC

Sigma has nearly 20 years of experience in process development, process characterization and validation, and manufacturing of therapeutic proteins. At KBI, she is in charge of the cell line, upstream, downstream, and analytical development groups that support development of 40 – 50 molecules per year. These molecules encompass all phases of development and represent mAbs, bi-specifics & fusion proteins, enzymes, vaccines, and complex glycoproteins. Prior to joining KBI in 2010, she was with Eli Lilly & Co. and Diosynth Biotechnology. At Lilly she led a process development group and also the high throughput cell line selection group and was a CMC Core Team Leader. At Diosynth she was manager of the Cell Culture group and was responsible for developing in-house (Merck) and client processes. Sigma’s core expertise are in phase I through commercial process development, scale-up/scale-down, and tech transfer. Sigma earned her Ph.D. in Chemical Engineering from Northwestern University. She completed her B.S. in Chemical Engineering from the University of Texas at Austin with High Honors.

Carnley Norman, Ph.D.

VP, Manufacturing Operations  |   Durham, NC

Carnley has over 18 years of therapeutic protein and vaccine drug substance process development, characterization, technology transfer and manufacturing experience with KBI Biopharma, Novartis, Astra Zeneca (MedImmune), Amgen and Merck. At KBI, Carnley previously led the Downstream Process Development group for close to 2 years. Prior to joining KBI in 2014, Carnley led and managed the Manufacturing Science and Technology (MS&T) purification groups at Novartis Vaccines (Lab and Manufacturing Support groups) focusing on process validation, technology transfer, manufacturing support process optimization/improvement in support of flu cell culture manufacturing. During his career, Carnley also held technical leadership roles for 9 new product introductions to commercial manufacturing sites including 4 new drug substance facility start-up projects. Two of these projects won ISPE Facility of the Year Awards. He also led process modeling initiatives at Merck, Amgen, MedImmune and Novartis. This includes facility simulation, fit-to-plant related modeling and equipment modeling using computational fluid dynamics (CFD). Carnley received his Ph.D. in Chemical Engineering from North Carolina State University.

Thomas Milici

VP, Engineering  |  Durham, NC

Tom has over 30 years of experience in the design, construction and operation of large scale GMP production facilities. Prior to joining KBI, Tom held the position of VP Manufacturing Operations and Site Head for Emergent BioSolutions in Baltimore, MD. Tom’s experience includes the design, construction, commissioning, validation and operation of microbial and mammalian cell culture facilities ranging from 100L to 7,500 L total production capacity. Tom has taken two products through licensure including FDA, EMA and other regulatory agencies through the Mutual Recognition program.

Sandra Lueken

VP, Quality Operations  |  Boulder, CO

With over 20 years of industry experience, Sandra’s background includes a full drug manufacturing lifecycle skillset including; R&D, assay development, tech transfer, scale up activities, bulk drug substance manufacturing, small molecule manufacturing, formulation, aseptic fill finish, lyophilization, packaging and global regulatory filing/inspection/approval activities from clinical through commercial product.  This includes support of filing review and inspections for 4 biologic approvals since 2014.

Prior to KBI, Sandra held the role of Senior Director, Quality Assurance, Biologics Quality at AstraZeneca (MedImmune) for 5 years supporting the approval of three Biologics and Director of Quality at Baxter Biopharma Solutions for 4 years.  Before Baxter, she held positions of increasing responsibility in the pharma industry at Hollister-Stier, Ventana Medical Systems, Systems Integration Drug Discovery Company and the Jerry L Pettis Memorial VAMC in Mineral Metabolism Research.

Sandra has a Bachelor’s degree from the University of Arizona and a MBA from the University of Arizona’s Eller Graduate School of Management.

Bob Todd, Ph.D.

VP, Process Development  |  Boulder, CO

Bob has over 25 years of experience in the development of processes for biotherapeutic products. 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.

Don Healey, Ph.D.

Senior VP and Site Head  |  The Woodlands, TX

Don has over 30 years experience in cellular immunology and immune regulation in both academic and biotech environments. Prior to joining KBI Biopharma, Don was Chief Scientific Officer at Opexa Therapeutics, developing autologous T-cell immunotherapies for the treatment of autoimmune disease. Previously, he held the position of Director of Immunology at Argos Therapeutics, and was responsible for the development of novel autologous dendritic cell therapies for the treatment of renal carcinoma and HIV. He is a former lecturer in immunology at the University of Leicester, UK, and held post-doctoral positions in the Department of Pathology, Cambridge University, UK, conducting studies on immunoregulation of autoimmune disease. Dr. Healey obtained his Ph.D. at the Hunterian Institute at the University of London, UK, and obtained his BSc in the Department of Pathology, Bristol University, UK.

Lauren Collison, Ph.D.

VP, Process Analytical and QC  |  The Woodlands, TX

Lauren has 15 years of experience in cellular immunology, specializing in T cell function, immune regulation, autoimmunity and immunotherapy. At KBI, she oversees process and analytical development and quality control. Prior to joining KBI in 2017, she was Director of Immunology at Opexa Therapeutics, and was responsible for product and process development of autologous T cell therapeutics as well as the development of analytical assays for the evaluation of cellular immune responses. Previously, she was at St. Jude Children’s Research Hospital where she researched mechanisms of immune regulation which lead to the identification of a novel regulatory T cell cytokine, IL-35. Lauren obtained her Ph.D. and B.S at the University of Texas at Austin.

Mark Lutgen

VP, Engineering  |  Boulder, CO

Mark has over 30 years of experience in engineering, project management, maintenance, validation, and manufacturing. Prior to joining KBI in 2017, Mark was a project director in Roche’s Global Engineering organization where he managed large capital projects at Genentech’s South San Francisco campus. At Amgen’s Colorado site, Mark managed numerous capital projects and technology programs. Mark was Director of Engineering and Operations at NaPro Biotherapeutics. His experience includes clinical and commercial facilities and direct support of product licensures by US FDA, EMA, and other regulatory agencies. Mark holds a M.B.A. from the Leeds School of Business at the University of Colorado, a B.S. in Chemical Engineering from Colorado State University, and is a certified Project Management Professional.