FOYA Panel
1:00 PM – 2:00 PM | East Red Level, Suite 10
ISPE’s Facility of the Year Awards (FOYA) is an annual program that recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, to reduce the cost of producing therapies, and demonstrate advances in project delivery. In this panel, hear from individuals who have been involved in this program, both from the selection committee and from the companies who were honored with this prestigious award. The conversation will focus on novel facility design, construction and start-up, and efficient operations that ultimately allow these companies to bring novel life changing products to patients.
Speakers:
Brad Ebel, Executive Director, Facilities and Engineering, CRISPR Therapeutics
Gil Stevens, Executive Director, Global Engineering & Capital Projects, Ultragenyx
Justin Ondrey, Sr Director Engineering, Iovance Biotherapeutics
Mario Miele, Senior Vice President, Facilities and Engineering, ElevateBio
James P. Grunwald, Senior Vice President Business Development, Arcadis
Biographies:
Brad Ebel, Executive Director, Facilities and Engineering, CRISPR Therapeutics
Brad Ebel is the Executive Director of cGMP Facilities and Engineering and Framingham Site Lead for Internal Manufacturing at CRISPR Therapeutics. Brad has over 20 years of experience in the biopharmaceutical industry spanning Manufacturing, Process Development, Pilot Facility, Site Operations and Finance. While at CRISPR, Brad’s first responsibility was to identify an internal cGMP manufacturing facility in the Greater Boston Area. For this project, his key responsibilities included: identifying a location, securing a lease, and interfacing with the architect, engineering, and construction companies. Brad has been responsible for overseeing the office, lab and GMP facility build, as well as ensuring the commission of the facility is completed on time and within budget. The construction of the CRISPR Therapeutics Framingham Manufacturing Facility is the seventh lab/facility build that Brad has worked on in his career. Brad holds his B.S. in Chemistry for Westminster College.
Gil Stevens, Executive Director, Global Engineering & Capital Projects, Ultragenyx
Gil Stevens leads Global Engineering and Capital Projects for Ultragenyx. Ultragenyx recently completed a greenfield site in Bedford, MA. This new site is the company’s first internal manufacturing facility, capable of clinical and commercial supply of the company’s portfolio of gene therapies. With over 30 years’ experience in Biopharmaceuticals, he has been directly involved in greater than $2.5B of facility expansion projects, globally. He brings a thorough understanding of operational considerations to the siting and design of facilities that support research, development and manufacturing of biopharmaceuticals. His approach to successful project execution is founded on establishing strong industry partnerships through creating a culture of mutual support and appreciation.
Justin Ondrey, Sr Director Engineering, Iovance Biotherapeutics
Justin is the Senior Director of Engineering within the Strategic Manufacturing Group at Iovance Biotherapeutics. He is currently responsible for the strategic capital planning and execution for the Iovance clinical and commercial sites.
With over 25 years of experience within pharmaceutical/biotechnology industry, Justin has gained core strategic experience in almost all therapeutic areas from OSD, API chemical and biological synthesis, vaccine drug substance and product, monoclonal antibody formulation and filling/medical devices, to cell therapies CART and TIL. While delivering engineering projects within these areas has always been Justin’s core focus, opportunities within CQV, Regulatory, R&D, Tech Transfer, Supply Chain and Real Estate Planning have added a well-rounded, balanced portfolio of experiences.
Justin began his career at Merck supporting several North American commercial sites. Following Merck, Justin worked at Sanofi supporting the largest Flu/Vaccine site in North America. Justin then entered the Cell Therapy space at Celgene/BMS before ultimately accepting his current role at Iovance Biotherapeutics.
Justin has a B.S. in Chemical Engineering from Lehigh University.
Mario Miele, Senior Vice President, Facilities and Engineering, ElevateBio
Mario has over 25 years of experience in biotech leading high profile capital campaigns and expansion projects. He is accountable for all aspects of facilities and engineering functions supporting R&D and GMP Operations as well as real estate and capital planning/execution.
Prior to ElevateBio, Mario directed all engineering, maintenance, and EHS operations for large antibody manufacturing sites, primarily at AbbVie. Prior to working for AbbVie, Mario gained extensive experience at a Boston-based Life Science A&E firm designing sanitary biologics manufacturing equipment, piping systems, and clean utility systems.
Mario has a B.S. in Chemical Engineering and M.S. in Management both from Worcester Polytechnic Institute.
James P. Grunwald, Senior Vice President Business Development, Arcadis
Jim Grunwald brings more than 30 years of experience in the AEC industry to his position of SVP, U.S. Business Development at DPS Group. He joined DPS Group in 2015 and previously served as Vice President of Strategic Development for Boston’s Project Operations. In this role, he successfully led teams and delivered strategic capital projects for leading biotech/pharmaceutical and advanced technology clients. Jim supports all of DPS’ internal and external client relationships with expert guidance in the areas of planning, risk assessment, site selection, estimating, CQV, and operational readiness. He also has special expertise in strategic planning and Real Estate Development focused on the unique needs of Life Science and Advanced Tech clients.
Prior to DPS, Jim held positions with leading CQV, Automation service providers and was a Principal of SciTech Builders, Inc., which focused on EPCM services for process manufacturing facilities.
Additionally, Jim fulfills the role of project sponsor for many of DPS’ strategic project initiatives, providing senior management oversight and guidance to project teams on behalf of clients including Moderna, Sanofi, AbbVie, Acorda, Thermo Fisher, ElevateBio, Waters Corporation, Lonza and others.
Jim is an active member of ISPE Boston and ISPE International, having previously served as president of the Boston Area Chapter Board of Directors and helping to start the ISPE Boston Chapter Scholarship Fund. He is also a founding member of the I2SL New England Chapter. Jim serves on the US Board of DPS Group and supports many local charities in the Boston area.
