Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional contract services to its clients. Gallus’ world-class facility in St. Louis is distinguished by nearly three decades of biologics development and over a decade of commercial cGMP manufacturing, including the ongoing manufacture of Remicade® and Stelara® for Janssen Pharmaceuticals. Gallus’ new facility in Princeton, NJ, has three decades of experience in process development and clinical manufacturing of mAbs, as well as large and complex proteins such as Fc-fusion proteins, IgMs and collagens, plus over 15 years of experience in commercial manufacture of ProstaScint®. Both sites maintain an exemplary quality and regulatory record. As a pure play CMO Gallus is positioned to execute across the entire development process while providing robustness needed and expected to meet and exceed evolving regulatory expectations.
The name Gallus derives from an ancient Glasgow dialect, meaning confident, bold and feisty. In modern Scottish usage, gallus means brilliant, amazing or better than you could have imagined. Gallus’ visual identity features a varying organic shape inspired by kaleidoscopic imagery. The kaleidoscope, invented in Scotland, has its origins in science and became a successful commercial product. The beautiful configuration one sees alters repeatedly with subtle manipulation of the apparatus, similar to patterns found in biological events such as cell division.
To be the most trusted provider of world-class contract manufacturing and development services for the pharmaceutical and biotechnology industry.
We empower customers to improve patients’ lives by leveraging our deep experience in process optimization and manufacturing with the proven ability to simplify complex technical and scalability challenges while maintaining an exemplary global regulatory record.
- Mark R. Bamforth, President and CEOMark is the President and CEO of Gallus BioPharmaceuticals. Mark founded Gallus in 2010 and completed the financing to acquire the St Louis site in 2011. Mark utilizes 22 years of experience from running global operations and a Pharmaceutical CMO business for Genzyme. Prior to this, Mark was a chemical engineer in the whisky industry and a petroleum engineer exploring for North Sea oil. Mark serves on the MassBio Board and is a founding Trustee of a charity, the Saltire Foundation, which offers young Scottish entrepreneurs the opportunity to experience and learn in high growth companies in the USA and beyond. Mark has a BS in Chemical Engineering from Strathclyde University, Glasgow, and an MBA from Henley Business School.
- Steven H. Kasok, Chief Financial OfficerSteve is a corporate co-founder and Chief Financial Officer of Gallus BioPharmaceuticals. He is responsible for the financial oversight of the organization and leads the Finance, Information Technology, and Human Resources areas. Prior to joining Gallus Steve served as Vice President and Treasurer of Millipore Corporation, where he was part of the transformation leading to the successful sale of the company to Merck KGaA. Steve's experience also includes being the Chief Financial Officer of Cabot Supermetals, Treasurer and Business Development Officer at Haemonetics Corp., and a variety of roles within Converse Inc. and GE. Steve holds a Bachelor's in Finance from Clarkson University and an MBA from Harvard Business School.
- Mark W. Bell, Chief Manufacturing OfficerMark is the Chief Manufacturing Officer at Gallus BioPharmaceuticals. He is responsible for the overall direction and guidance of the operational activities at Gallus. Mark brings over 30 years of industry experience to his role. Prior to Gallus, Mark was the General Manager as well as Senior Director of Manufacturing for the Centocor Biologics St. Louis site. During his tenure Mark led the transfer of commercial and Phase 3 therapeutic antibodies utilizing a perfusion technology platform, and was instrumental in the achievement of licensing by the FDA and EMEA. Mark's experience also includes Serono, Wyeth and J&J. Mark holds a Bachelor's degree in Biology from Olivet Nazarene University.
- Mike E. Ultee, Ph.D., Chief Scientific OfficerMike is the Chief Scientific Officer for Gallus BioPharmaceuticals and serves as a scientific resource for projects and a liaison with our clients and the biopharmaceutical community. These activities include troubleshooting of processes for production and purification of challenging proteins, and maintaining through publication and presentation Gallus’ reputation for strong science and technical achievement. Mike previously held this and various positions at Laureate BioPharma since 1987, including leading the Scientific Series spotlighting strategies and methods for overcoming challenges in biopharmaceutical development. Mike has over 30 years of experience in the biopharmaceutical industry and has worked on the development of antibodies since 1975. Dr. Ultee began his career in Research and Development, where he was part of the team that developed two licensed biopharmaceuticals. He holds 4 U.S. patents and has published numerous scientific articles. Prior experience includes postdoctoral research in immunology at NYU Medical School. He is a frequent speaker at biopharmaceutical conferences, and a member of the editorial advisory boards of Bioprocess International and BioPharm International. Mike earned his graduate and undergraduate biochemistry degrees from Northwestern University and Dartmouth College.
- Robert J. Broeze, Ph.D., Senior VP, Bus. Dev.Dr. Broeze is the Senior Vice President of Business Development at Gallus BioPharmaceuticals and serves as an experienced technical and business resource for the business development team. Dr. Broeze has over 20 years of experience in the biopharmaceutical industry including positions as Chief Commercial Officer and Chief Executive Officer at Laureate BioPharma. His technical expertise spans research, development, protein characterization, validation, testing and cGMP manufacture of biopharmaceutical products, from pilot to Phase III clinical and commercial scale with a strong emphasis on monoclonal antibody products for therapeutic and diagnostic use. Dr. Broeze previously held senior positions in R&D and operations at Purdue BioPharma L.P., Bard BioPharma L.P and at Cytogen Corporation where he played a key role in the commercialization of two monoclonal antibody products. Dr. Broeze worked as a Postdoctoral Fellow in the Department of Molecular Biophysics and Biochemistry at Yale University where he studied the molecular biology of the interferon system and is a graduate of Rensselaer Polytechnic Institute where he earned his B.S. and Ph.D. degrees.
- Ed A. Haas, VP, St. Louis OperationsEd is the VP of St. Louis Operations of Gallus BioPharmaceuticals. Ed is responsible for the clinical and commercial manufacturing operations at Gallus. Ed has over 30 years' experience manufacturing biologics. Ed worked 11 years with Centocor Biologics, LLC and Wyeth BioPharm; where he established a manufacturing team which initiated plant start-up, received commercial and clinical product technical transfers, manufactured Phase 2 to Phase 3 clinical products, launched a licensed product with world-wide health agencies, and successfully transferred multiple processes to other commercial manufacturing sites. Ed's previous experiences include manufacturing leadership of a CMO start-up at Sigma Chemical Co. and supervising a purification team responsible for the commercial manufacture of two therapeutic proteins from human plasma at Bayer Pharmaceuticals. Ed is Green Belt certified. Ed holds a Bachelor's degree in Chemistry from St. Louis University.
- David J. Kenyon, Ph.D., VP, Process SciencesDave is the VP of Process Sciences at Gallus. Dave oversees all aspects of the technical transfer and process development of projects to Gallus. With over 25 years of industry experience, Dave has held a variety of positions in development and quality. Dave was most recently Senior Director of Quality for Centocor Biologics and was responsible for Quality Assurance, Quality Control, and Health Authority Inspection activities. He has also led the Technical Services Group of Centocor Biologics and was responsible for the technical transfer and process validation of a new platform of therapeutic monoclonal antibodies. Dave’s additional experience includes Director of Vaccine manufacturing for Wyeth at the Marietta, Pennsylvania facility. Dave holds a Bachelor's in Microbiology from The Ohio State University, a M.S. in Immunology from LSU Medical Center in New Orleans and a Ph.D. in Microbiology jointly from Rutgers University and the University of Medicine and Dentistry of New Jersey.
- Claudette Kile, VP, Quality and RegulatoryClaudette Kile is the Vice President of Quality and Regulatory at Gallus BioPharmaceuticals. Claudette is responsible for overall product quality and regulatory activities at Gallus. Claudette brings over 27 years of industry experience in medical devices, biologics, and pharmaceuticals to her role. Prior to Gallus, Claudette was the Sr. Director of Quality at Jazz Pharmaceuticals overseeing global clinical trials, drug safety and pharmacovigilance. Claudette’s experience also includes site quality head for Emergent BioSolutions where she oversaw the development, testing, and supply of vaccines and antibody therapy products for non-clinical and clinical trials. She established her own consultancy focusing on regulatory affairs, compliance and quality assurance, serving a diverse client base ranging from corporations to contract research organizations. Additionally, Claudette held roles at Abbott Labs, eV3, and Guidant. Claudette holds a Bachelor’s degree from Clayton College of Natural Health.
- Todd H. Tobiasz, Senior Director, Finance/ControllerTodd is the Senior Director of Finance and Controller for Gallus and is responsible for finance and accounting. He has over 30 years of experience in a number of controller and financial planning positions. These roles include the US controllerships for the of Sensient Technologies Color division, the Borden Foods Pasta division, Parmalat Foods Bakery division and as director of financial planning and analysis for Sigma-Aldrich Corporation. Todd's experience also includes financial roles with Electronic Data Systems and McDonnell Douglas Corporation. Todd has his bachelor degree in accounting and his MBA from Washington University in St. Louis and his CPA certification.
- Rebecca A. Shocklee, Senior Director, Human ResourcesRebecca Shocklee is the Senior Director of Human Resources for Gallus BioPharmaceuticals. Rebecca oversees all facets of human resources. She has over 14 years of experience in this profession. Prior to joining Gallus, Rebecca was a Global HR Business Partner at EMD Millipore. Rebecca has also supported the Drug Discovery, Life Science, and Pharmacy Benefit Management industries at other world-class organizations such as Sigma-Aldrich and Express Scripts. Rebecca holds a Bachelor's degree from Illinois State University, is a member of the SHRM organization, and has her SPHR certification.
- Jeffrey J. Strand, Senior Director, Princeton OperationsJeff is the Senior Director, Site Operations for Gallus BioPharmaceuticals and is responsible for site operations at the Princeton, New Jersey facility. Jeff has over 22 years of experience in the development, technical transfer, and manufacturing of biologics including 11 years at Centocor Biologics, LLC and Wyeth BioPharma; where he established a world class manufacturing team responsible for transfer, scale up, and manufacture of clinical and commercial products. Jeff also has previous experience in a Quality Assurance leadership role and as a Plant Manager for a small molecule manufacturing facility. At Gallus, Jeff held a previous role of Director of Program Management for 2.5 years, establishing and leading a team responsible for the oversight of all CMO customer programs. Jeff is Green Belt certified in Lean/Six Sigma and holds a Bachelor's degree in Biology / Pre-Pharmacy from Augustana College and a Master’s degree in Molecular and Cellular Biology from the University of Missouri-St. Louis.
- David A. Fritsch, Senior Director, EngineeringDavid Fritsch is the Senior Director of Engineering at Gallus BioPharmaceuticals. Dave heads Engineering, Facilities and OpEx functions at Gallus. Dave has over 20 years' experience including pharmaceutical manufacturing, capital planning and project management. Prior to joining Gallus, Dave was most recently with Covidien (Mallinckrodt), where he managed capital projects including renovation and facility expansion projects for filling of injectable and solid oral dose products. Dave has experience in manufacturing of parenteral products and participation in regulatory inspections. Dave holds a Bachelor's in Chemical Engineering from the University of Notre Dame, and a MBA from Washington University in St. Louis where he is an adjunct professor.
- Kevin F. Wilkinson, Director, Information TechnologyKevin is the Director of Information Technology at Gallus BioPharmaceuticals. Kevin is responsible for IT infrastructure, operations and resources to support business initiatives. He has more than 25 years Information Technology experience working in manufacturing and computer system support industries. Kevin attended Columbia College and holds his Bachelor of Science Degree in Computer Info Systems (BS.CISS). He has spent the last 12+ years with Nordyne Inc. in various IT roles, most recently managing Global IT. Kevin is also a veteran of the United States Army.
- Angela Colarusso, Director, Princeton Program ManagementAngela is the Director of Program Management for Gallus BioPharmaceuticals at the Princeton, New Jersey facility, a role to which she brings more than 10 years of biologics experience. Angela’s responsibilities include the oversight of all active client projects and proposals for prospective work at the Princeton facility. Prior to her role in Program Management, Angela worked as a Scientist in the Upstream Manufacturing group at Laureate BioPharma. Angela’s previous experience includes working as Scientist at Centocor Biologics,LLC where she worked in Upstream production of the commercial biologic, Remicade®, for five years. She holds a Bachelor’s Degree in Biology and Philosophy from the University of Scranton.
Board of Directors
- Mark R. Bamforth, President & CEO Gallus
- Geoffrey Cox, Ph.D., Independent Director
- David Lavins, Ridgemont Equity Partners, Vice President
- Shailesh Maingi, Kineticos Life Sciences, CEO
- Scott Poole, Ridgemont Equity Partners, Partner
- Walker Poole, Ridgemont Equity Partners, Partner
- Jack Purcell, Ridgemont Equity Partners, Partner