We recognize that more than a facility is necessary for an attractive, successful contract manufacturing organization. Experienced operating personnel and management are key to success. We believe Gallus will have both, benefiting from Mark Bamforth's experienced leadership and the history of successful operation at the St. Louis facility.
October 1, 2013 - Gallus Acquires Laureate
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Gallus Biopharmaceuticals was formed with the vision of being a world-class contract manufacturer (CMO) for the development and manufacture of biologics. We acquired our St. Louis site from Johnson & Johnson, which provided a strong platform with nearly three decades of biologic manufacturing experience at the location – a duration quite rare in the industry. Gallus invested heavily in expanding capabilities, and a highly experienced scientific team with long tenure combines with state-of-the-art technology to offer exceptional service to large pharma, biotech, and virtual biotech clients. We provide the quality and reliability necessary to support the development and commercialization of biologics, and our expertise is demonstrated in the production of two current commercial products for Johnson & Johnson – Remicade® and Stelara®. Our differentiation centers on flexibility, which is evident in service offerings, with single-use and flexible stainless steel technologies, and business models based on traditional pay-per-run or additional benefits from our SuiteSPACE® virtual ownership concept.
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 CEO
Mark 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 Officer
Steve 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.
- Joseph P. Coffey, Chief Commercial Officer
Joe is the Chief Commercial Officer for Gallus BioPharmaceuticals. He heads the commercial team, including sales, marketing and client offering functions within Gallus. Joe has over 24 years experience in biotech, pharmaceutical and contract manufacturing services. Prior to joining Gallus, Joe was with Baxter International, as Vice President, Sales BioPharma Solutions fill/finish CMO business unit, leading the global strategic accounts management team. Prior to Baxter, Joe spent 19 years of service with Abbott in progressive commercial responsibilities. Joe also serves as a member of the Board of Directors for the Strategic Account Management Association. Joe has a Bachelor of Science in Economics from the University of Wisconsin-Madison.
- Mark W. Bell, Chief Manufacturing Officer
Mark is the Vice President of Site Operations 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.
- Ed A. Haas, VP, St. Louis Operations
Ed 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 Sciences
Dave 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.
- Todd H. Tobiasz, Senior Director, Finance/Controller
Todd 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.
- David A. Fritsch, Director, Engineering
David Fritsch is the 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.
- Rebecca A. Shocklee, Senior Director, Human Resources
Rebecca 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.
- Kevin F. Wilkinson, Director, Information Technology
Kevin 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.
- Mike E. Ultee, Ph.D. - Chief Scientific Officer
Mike 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.
- Jeffrey J. Strand - Senior Director, Princeton Operations
Jeff 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.
- 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.
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, Principal
- Walker Poole – Ridgemont Equity Partners, Partner & Executive Cmte member
- Jack Purcell – Ridgemont Equity Partners, Principal
The Gallus Commitment to Environmental, Health, Safety and Sustainability
Gallus is committed to maintaining a safe workplace for its employees, contractors and visitors. We embrace the implementation of sustainable practices to reduce our impact on the environment. We pledge to:
- Comply with all environmental, health, safety and sustainability (EHS&S) laws, regulations, and other requirements applicable to our business.
- Provide the training and tools necessary to conduct work in a safe and environmentally responsible manner.
- Empower all of our employees and contractors to proactively address unsafe behavior and conditions before either result in an injury or environmental incident.
- Set measurable EHS&S goals, and regularly review our progress.
- Evaluate and address the EHS&S risks as a standard part of our business practices.
- Continually improve our EHS&S performance by understanding our environmental footprint.
- Commit to sustainability through eliminating or controlling risks.
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