| Kyle Anderson, PhD Senior Manufacturing Scientist, Manufacturing Sciences Biogen Kyle Anderson is a Senior Engineer III at Biogen focused on the development and deployment of an enterprise recipe management tool for large molecule batch processes. Kyle received his PhD in microbiology from Cornell University. He has held numerous roles in the Biotechnology field, including early phase process development, supporting cell culture and purification activities at Biogen’s manufacturing facilities, and as a technical product leader for two of Biogen’s commercial assets. | |
| Steve Austin Senior Manager, Automation Engineering Biogen Steve is the Senior Manager of Automation Engineering for Biogen and has over 25 years of experience in the Life Sciences industry. While supporting process automation as an engineer for Bayer, Wyeth Biotech, Eisai and now Biogen, Steve has had the opportunity to contribute to the development of new methodologies and technologies for process control systems and contribute to long-term strategic development of site process controls systems, while ensuring compliance with all regulatory agencies and safety requirements. His efforts at Biogen currently include developing technology platforms and business systems, as well as standardizing and improving automation practices. Steve holds an AS in Electronic Engineering and a Bachelor of Applied Sciences degree in Information Technology/Computer Systems. | |
| Andrew Baird Principal Process Technologist Jacobs Engineering Andrew Baird is a Principal Technologist with Jacobs’ Advanced Facilities business, one of the largest professional services providers to the electronics, life sciences, and specialized manufacturing markets. Global biotechnology and plasma companies turn to Andrew for his experience as a process engineer, process team leader, and knowledge in equipment and clean utility design for human plasma fractionation and bulk substance manufacturing. He leads clients from concept through detailed design to field supervision, construction, qualification, and start up. In addition to working on one of the first successful gene therapies for prostate cancer, Andrew performs peer reviews on plasma and drug substance manufacturing facilities. With nearly 30 years of experience designing cell culture manufacturing and purification systems, including single-use systems, project involvement also includes the world’s largest plasma batch size and plasma processing throughput. As well as serving Life Sciences clients, Andrew also has experience in food and beverage, fibers manufacturing, and several landmark projects for largescale fermentation for yeast, bacteria and algae. He is active in the International Society of Pharmaceutical Engineering and is currently assisting with their Baseline® Guide on Water and Steam. Andrew lives in Greenville, South Carolina. When he is not working, he enjoys spending time with his family, scuba diving and traveling. He is also an avid consumer of fine food and wine. | |
| Rodolphe Barrangou, Ph.D Todd R. Klaenhammer Distinguished Professor in Probiotics Research North Carolina State University Dr. Barrangou is the T. R. Klaenhammer Distinguished Professor in Probiotics Research in the Department of Food, Bioprocessing and Nutrition Sciences at North Carolina State University, focusing on the evolution and functions of CRISPR-Cas systems, and their applications in bacteria used in food manufacturing. Rodolphe also spent 9 years in R&D and M&A at Danisco and DuPont in the Food Industry. Recently, for his work establishing the biological function of CRISPR, Rodolphe received the 2016 Warren Alpert Prize, the 2016 Canada Gairdner International Award, the 2017 NAS Award in Molecular Biology and the 2018 NAS Prize in Food and Agriculture Sciences, and was elected in to the NAS, NAE and NAI. Dr. Barrangou is also the former Chairman of the Board of Directors of Caribou Biosciences, a co-founder and member of the Scientific Advisory Board of Intellia Therapeutics, a co-founder of Locus Biosciences, a co-founder of TreeCo, an advisor to Inari Ag and Invaio, and the Editor in Chief of the CRISPR Journal. Dr. Barrangou earned a BS in Biological Sciences from Rene Descartes University in Paris, France, a MS in Biological Engineering from the University of Technology in Compiegne, France, a MS in Food Science from NC State, a PhD in Genomics from NC State and a MBA from the University of Wisconsin-Madison. | |
| Nate Beekman Process Automation Consultant Avid Solutions Nate Beekman is an NC State Chemical Engineer grad and has been working in the life sciences industry for about 3 years. After graduation, Nate began working as a systems integrator doing process control and automation in life sciences and chemical facilities. He has been a member of ISPE for a little over a year and is involved in the Students/YP committee. Outside of work, Nate loves to spend time outdoors on the incredible greenways and trails around Raleigh. | |
| Shannon Chase Associate and Senior Project Manager CRB Shannon Chase is an Associate and Senior Project Manager with 20 years of experience at CRB in the biotechnology industry, managing capital projects through all phases from conceptual design through construction. With a broad range of project experience from intricate process-driven facilities and piping retrofits, to large greenfield projects upwards of $200MM, Shannon brings a strong technical focus and a deep sense of commitment and drive to her projects and sets the pace for her teams. Naturally focused on project metrics, she strives to achieve the best outcomes for her teams and her clients. Her ability to form solid relationships with her internal and external teams allows for an environment focused on innovation and excellence. Specialties: Integrated Design and Construction Execution, Planning and Scheduling, Interdisciplinary Coordination, Project Tracking Metrics, Change Management, Client Communication, Biotech Process Engineering, cGMP Facility Design | |
| Jennifer Lauria Clark Executive Director of Strategic Development Commissioning Agents, Inc. Jennifer Lauria Clark, CPIP is the Executive Director of Strategic Development for CAI, where she is responsible for business development, key account management, marketing, and consulting support. She has over 14 years of experience in regulated industries. Previously she held positions as a consultant where she provided services for Merck, BD, GSK, Biogen and others. Jennifer Lauria Clark has been a Member of ISPE for more than 15 years and actively involved in the Society's local and international activities. She is Past President of the ISPE CaSA Chapter, is a Past Chair of ISPE’s Young Professionals Committee, and currently is Chair for both the ISPE Annual Meeting Planning Committee as well as the Women In Pharma Steering Committee. Jennifer Lauria Clark also finished a four-year stint as a Director on the ISPE International Board. She has a degree in Industrial Engineering from North Carolina State University. Jennifer Lauria Clark earned her ISPE CPIP designation in 2012. She is enrolled at NC State for her MBA and looks forward to starting in the Fall. Jennifer’s passion is people. She enjoys spending time to get to know individuals and help solve their problems. She has a great network or mentors, team mates, colleagues, and friends who help her succeed in today’s business world. Jennifer is a champion for students and young professionals trying to find their way in industry. | |
| Justin Cook Senior Manager of Technical Training Sequence, Inc. Justin Cook is a Mechanical Engineer who has served in the Pharmaceutical industry for over 12 years. Justin began his career supporting Process Automation commissioning and qualification projects. Along the way he has had an opportunity to support process/automation design, automation integration efforts, lifecycle document development, and process equipment commissioning and qualification efforts. Justin has also served as a project manager for multimillion scopes of work. His current role, as a technical trainer for Sequence, Inc. consists of providing cross functional training in the areas of process engineering, automation engineering, and commissioning. Justin has had a great deal of experience with DeltaV process automation platforms and is currently working to expand employee exposure to Rockwell, Siemens, and ABB platforms. | |
| Bo Crouse-Feuerhelm Vice President, Client Solutions Director JE Dunn Construction Bo is Vice President, Client Solutions at JE Dunn Construction where she is on the Leadership Team and responsible for business development. She is a strategic client relationship management professional with more than 25 years of experience in the design and construction industry serving in leadership, mentoring, volunteering, and client development roles. She is an active member of the International Society for Pharmaceutical Engineering (ISPE) and received the first ISPE-CaSA Award for Dedicated Service in March 2019. She has focused nearly her entire career in the biotechnology and pharmaceuticals industry developing strong relationships with clients, partners and equipment manufacturers. Bo is a Past President of the ISPE-CaSA Chapter and worked on numerous ISPE International committees. Currently, Bo is a member of the Women in Pharma Committee. | |
| Darren Dasburg Biotech Executive and Entrepreneur 40 years experience in technical operations from RTP construction growth to Colorado biotech plant general management. Worked as internal and external service provider in every part of the world. Currently an Executive in Residence at NC State assisting two start ups while consulting as a cell and gene subject matter expert for industry. | |
| Chris DiPaolo President and Founder PROTECS Cris DiPaolo is the president and founder of PROTECS, a full-service design-build project and construction management firm. Headquartered in Plymouth Meeting, PA and with offices in NC, NJ, UT and DE, PROTECS focuses on serving private and public clients in high-tech and highly regulated sectors. Chris has more than 30 years of engineering experience, managing over $700 million in project value, construction management, commissioning and validation of technically complex projects within the pharmaceutical, biotechnology, semiconductor, food, healthcare and science and technology business sectors. He has successfully completed projects for a diverse portfolio of clients, from Fortune 500 to venture capitalized start-up companies. Chris’s expertise is focusing the design effort to meet a “targeted cost” from the onset of the project regardless of size, complexity or market sector involved. By doing so, PROTECS assists clients to meet or exceed their performance, compliance, time-to-market, and capital budget goals. In addition, Chris specializes in assisting start-up & emerging companies with their real estate and funding requirements that enable their technology to be realized and grow. | |
| Bailey Forrest Senior Project Director Fluor Construction Director/Site Management on the DAPI-US Project in Clayton, NC. With more than 25 years of industry experience, Bailey’s projects have included pharma manufacturing, PV manufacturing, purification, and fill finish facilities, as well as utilities and warehousing. His project experience has included management of module large-scale, and superskid types of projects. Two of the projects were on greenfield sites, three projects received ISPE annual awards, and two of the projects received the highest annual award possible within Fluor – the Hugh Coble Award – for project execution. Bailey is a Raleigh resident and holds degrees from NC State University. | |
| Ashley Franchi Senior Engineer, Capital Projects Biogen Ashley Franchi is a Senior Engineer at Biogen responsible for overseeing capital projects at the 900 Davis Drive Campus. With 12 years of industry experience scoping, designing, constructing, and starting up large and small scale manufacturing facilities in RTP. Ashley’s projects have included gene therapy, oral solid dosage manufacturing, oligonucleotide manufacturing and fill finish facilities. Prior to joining Biogen, she was a Project Manager on CRB’s Construction team responsible for procurement, budget management, safety, quality and schedule adherence for capital projects. Ashley holds a Bachelor of Science in Civil Engineering from Virginia Tech. | |
| Gary Gray Engineering Consultant, Global Process Engineering Group Grifols Gary is a member of Grifols Global Process Engineering group. He has over 30 years experience in the biotech/pharmaceutical industry, half of that time with architectural-engineering firms and the remainder with Manufacturing companies (Bayer, Talecris, Grifols). He has experience with human plasma fractionation and purification, recently serving as Process Lead Engineer for Grifols NFB facility. He also has project experience in the areas of fermentation and recovery, solid dose drug forms and clean utilities. Gary earned both Bachelors and Masters degrees from Virginia Tech. He is a registered professional engineer in four states. | |
| Wendy Haines Associate Director of Technical and Scientific Services PharmEng Technology Dr. Wendy Haines, Associate Director of Technical and Scientific Services at PharmEng Technology, has 20+ years of experience in both the research and biopharmaceutical arenas, encompassing process design, analysis, validation, project/protocol management and scientific writing. Dr. Haines is a board-certified toxicologist (DABT) and provides toxicological assessments for multi-product facilities, extractable and leachable assessments and has performed cleaning validation. Dr. Haines has been an ISPE member for 25 + years and is a Past Chair of the International YP Committee and is a Past President of the CaSA Chapter. | |
| Pablo Hernandez Director, Project Management Services PEG Contracting Pablo is the Director, Project Management Services with PEG Contracting Inc. He is a Life Science Executive with 25+ years of experience working within R&D, QC, and Biotechnology Manufacturing Processes. Pablo is a Mechanical Engineer with proven, practical, and hands-on experience in capital real estate, facilities management and site engineering; developing business strategies, creating site master plans, building complex infrastructures, managing large construction projects, and operating biotechnology sites. | |
| Christine Hofnagel Partner, Process Architect JacobsWyper Architects Christine Hofnagel, Partner at Jacobs Wyper Architects, is a recognized expert in cGMP facilities and process architecture for pharmaceutical, biotechnology and industrial clients, she excels at the design and programming of smart, efficient spaces that support the functions and flows of these facilities. | |
| Marisol Hydock Process Specialist BlueBird Bio Marisol Hydock is currently a Process Specialist at bluebird bio’s vector manufacturing facility. Her primary role at the Durham facility start-up has been single-use process design and manufacturing support. In her 10 years in industry,Marisol has also been previously involved with a biologics manufacturing start-up, performed process engineering for a large contract manufacturer, executed several process validation campaigns, and managed high value equipment vendor accounts where she wasresponsible for assisting customers with single-use process design. Her experience spans all clinical phases – from pre-clinical to commercial manufacturing. Marisol has been a member of ISPE since 2008 and has held positions locally such as student chapter president at NC Central University and Student Affairs Committee chair for the CaSA chapter. | |
| Kendall Kessler Director, BTx PS | Business Strategy, Operations & Facilities Pfizer Kendall Kessler, a Director in Business Strategy ＆ Operations (BSO) group within Pfizer’s Biotherapeutic Pharmaceutical Sciences (BTxPS) Department. He and his team lead lab, office and support area renovation/move projects for BTxPS’ organization of 800+ colleagues at 6 global sites. His career in laboratory operations spans >25 years, primarily with Pfizer. His expertise in space optimization designs fit-for-purpose lab, office and ancillary spaces promoting cross-pollination & innovation with scientific staff. He led the implementation of ‘5S’ lab organization processes to improve scientific equipment and space sharing for highest use plus Pfizer’s new 295,000sf R&D labs, ensuring that scientists/staff have state of the art, flexible and collaborative work spaces to bring medicines to patients faster. He holds a BS degree in Chemistry from University of IL, MS degree in Chemistry from St. Louis U and an MBA from Washington U-Olin Business School. | |
| Matt Kuntz EHS Manager/Operations; EHS Director for the DAPI-US Project Novo Nordisk Matt the executive director for EHS for the DAPI-US project for Novo Nordisk. Site Operations Manager on the DAPI-US Project in Clayton, NC. With over 19 years’ experience working in pharmaceuticals, medical devices and contract research, Matt has led a variety of world class programs across the spectrum of EHS and utility systems. His experience has included oversight of greenfield and mid-cap construction projects, operational EHSUtilities programs and various sustainability efforts. Additionally Matt oversaw the unique construction of the $40 MM publicprivate partnership resulting in the R. Steven Biggs Regional Wastewater Pretreatment Facility. Previous employers include Johnson & Johnson, Catalent and Novo Nordisk. Matt is a resident of Raleigh, NC and holds a B.S. degree from Wilkes University in Wilkes Barre, Pa | |
| Steve McDaniel Director of Science & Technology EwingCole Steve is Director of the Science & Technology Practice at EwingCole, focusing on the firm’s planning and design efforts for laboratory and manufacturing projects for biopharmaceutical, education, and healthcare clients. He has delivered high-quality projects in 15 states in the US plus Portugal, Ireland, and the United Kingdom. Steve believes in the power of teamwork and the practice, as well as its clients, have benefited from this collaborative approach. With over 30 years of experience in the planning and design of research labs and office space across the US and internationally, Owners rely on his command of complex R&D requirements and corporate environments to develop efficient, flexible facilities. Steve’s work has won two AIA design awards, and he has served as a reviewer of laboratory construction grant applications for the National Institutes of Health. He has lectured on flexible lab design concepts and has published articles in R&D Executive, Lab Design and American Laboratory Magazine. | |
| Chad Merewether Engineering Manager PCI Chad is the Engineering Manager of Project Services at PCI. Chad has his PE license in Control Systems and a Bachelor of Science degree in Biomedical Engineering from ECU with an extensive background in Commissioning, Qualification, Validation and CMMS Data Engineering projects. While at PCI, he has worked on several site start-ups, expansions, and owner transfer projects. Chad led multiple service teams and coordinated with other service contractors to meet schedule needs for successful project completion. His experience in CQV, Maintenance, Calibration and CMMS data systems has given him the opportunity to identify and implement efficiencies in his Clients’ asset lifecycle. He and his team offer Commissioning, Qualification, Validation, and Consulting services to clients in the Life Sciences industry. . He can be contacted at cmerewether@pci-llc.com. | |
| Rick Moeckel Executive Vice President, Institutional Business Unit Leader Claycorp, Inc. Rick Moeckel, LEED AP BD&C, DBIA, is EVP & Shareholder and Institutional Business Unit Leader managing projects in higher ed, life sciences and healthcare for Clayco, a national design-build company. With 18+ years of experience in the design-build industry, Rick is responsible for the overall management of the Institutional Business Unit and is involved in projects from beginning to end. Rick is proficient in all aspects of design and construction, providing clients with proven solutions and delivering complicated projects on time, on budget and with the highest quality, building lasting relationships in the process. He is a strong advocate for the innovative and collaborative project delivery method that is the foundation of Clayco’s integrated approach, and looks for clients, projects and relationships that understand and embrace the partnering concepts. Rick oversees the team and is responsible for the success of the project for both the team and the Owner’s perspective. | |
| William (Bill) Monteith Executive Vice President of Technical Operations Cellectis William {Bill} Monteith joined Cellectis in November 2018 as Senior Vice President US Manufacturing responsible for the selection, construction and buildout of Cellectis’ first gene-edited allogeneic manufacturing facility in the US called IMPACT. Bill Monteith was named Executive Vice President of Technical Operations in July 2019. Before joining Cellectis, Mr. Monteith was the Chief Operating Officer for Hitachi Chemical Advanced Therapeutic Solutions (formerly PCT). While at Hitachi, He was part of the executive team overseeing the merger with Hitachi and went on to build a cell and gene therapy facility in Yokohama Japan in addition to being responsible for the US based facilities in Allendale New Jersey and Mountain View California. Prior to that, Mr. Monteith was the VP and General Manager, and then Executive VP, Technical Operations, for Dendreon which was the first autologous cellular therapy to get approval in the United States. He has also held leadership roles at Sandoz, Shire, and Wyeth pharmaceuticals, ranging from technical operations to quality assurance. Bill Monteith is a dynamic global pharmaceutical Operations and Quality Executive with a documented record of organizational success and a proven record of accomplishment in strategic planning and execution, business process improvement, cost reduction, FDA and DEA regulatory compliance, facility startup and turnaround, technical transfer and analytical method validation, supply chain, and multi-plant management. Mr. Monteith received his Bachelor of Science in pre-medical studies with a major in Chemistry from Saint Lawrence University in Canton, NY. | |
| Andrew Passarotti Associate Manager BlueBird Bio Andrew Passarotti is a Supply Chain manager who works at bluebird bio’s start-up facility in Durham, NC to build a reliable, manufacturing-focused Supply Chain organization. Andrew believes that the treatments that are in development todayhave the potential to transform the lives of patients with rare diseases, which makes all of this work worth the effort. Andrew has previously served in various Manufacturing roles both on and off the floor with focuses on aseptic processing, large-scale bufferpreparation, and materials management. Andrew holds a Bachelor’s of Science in Chemical Engineering from Carnegie Mellon University. | |
| Steven Pincus, PhD Head of Science and Innovation FujiFilm Diosynth Biotechnologies Texas Dr. Pincus is responsible for the evaluation of new technologies for Advanced Viral Therapies and establishing and maintaining collaborations to foster innovation and development of training programs for qualified candidates for employment at FDBT. Prior to this role Steve served as Associate VP Virology and Analytical Development where he established and lead teams responsible for establishing, developing and qualifying methods to support Advanced viral therapy programs. Steven obtained his B.S. and Ph.D.in Biochemistry from the State University of NY at Buffalo. His Ph.D. thesis project involved studies on the mechanism of Adenovirus DNA replication and he gained experience growing and purifying multiple Adenovirus serotypes. He obtained his post-doctoral training in the microbiology department at the State University of NY at Stony Brook. | |
| Clay Schaeffer, PE Principal Process Engineer, Global Process Engineering Biogen Clay has spent the past 35 years performing process and process automation designs for mutiple industries, including 25 years in pharma and biotech. He background includes manufacturing, automation engineering, process design, facility startup, project management and engineering management. Currently Clay is a Principal Engineer with Biogen working on strategic automation initiatives throughout the company’s various research and manufacturing sites. Clay holds a BS in Chemical Engineering from the University of Colorado and has his PE license in Control Systems. | |
| Stacy Sodomsky Process Engineer CRB Stacy Sodomsky is a Process Engineer at CRB, focusing in biological process and facility design. Stacy’s facilities experience includes conceptual and detailed process design as well as equipment procurement and construction support services. A recent graduate of North Carolina State University, Stacy holds two degrees: A Master of Science in Chemical Engineering and a Bachelor of Science in Biology. | |
| Katie Stember, PhD Assistant Director of Life Science Economic Development North Carolina Biotechnology Center Dr. Katie Stember joined NCBiotech in October 2018 as the Associate Director for Life Science Economic Development. She is responsible for supporting efforts to create, manage, and measure programs leveraging North Carolina’s technology-based assets to attract and retain life science jobs and investments. In 2016, she founded a social media community called Scientists of North Carolina that shares scientists’ stories with the goal of showcasing diversity in science and breaking down stereotypes around what scientists look like and do for work. Katie earned her bachelor’s degree in Behavioral Neuroscience from Northeastern University in Boston, and completed her Ph.D. in Pathology at the University of North Carolina at Chapel Hill. | |
| Jon Thompson Director of Life Sciences Avid Solutions Jon graduated from Indiana University with a BS in Chemistry and holds an MBA from Indiana Tech. He started his career in Specialty Chemicals but moved quickly into a Life Sciences role and has been in that industry for over 20 years. A large portion of his career has been spent in various roles implementing digital and technology solutions into Life Sciences facilities such as Eli Lilly and Baxter. In addition, he served as the Practice Director for the Life Sciences delivery team at WonderWare. He has a passion for using technology to improve the quality and operational efficiency of regulated processes. | |
| Jeff Willis Senior Manager Metrology & Instrumentation Services Humacyte Jeff has over 35 years of experience as a Metrologist providing technical and engineering expertise to maximize a site’s equipment availability, reliability and reduce maintenance cost through system and process implementation. The last 12 years he has been working in the Pharmaceutical industry with his latest role as the Facility, Metrology Manager at Humacyte where he has been responsible for the design and set-up of the Metrology and Preventive Management program. Humacyte is a regenerative medical technology company in Durham committed to becoming the leader in novel human acellular matrix products for vascular and non-vascular applications. He has been working with some great teams dedicated to getting Humacyte through the Commissioning, Qualification, and Validation process. | |
| Tim Winstead Regional Director EwingCole Tim has over 35 years of experience in facility planning, design, and project administration. With a focused expertise in science and technology trends, Tim is passionate about helping institutions further their missions through careful space programming and planning. His broad range of experience includes R&D and manufacturing facilities for the pharmaceutical industry, as well as teaching and research facilities for higher education. His ability to understand clients’ needs, simplify problems, and explain technical issues in layman’s terms enables him to build consensus among multiple constituencies and develop successful design solutions for his clients. Tim’s career features academic science facilities at Yale University, Duke University, MIT, and corporate and institutional projects at Novartis, Johnson & Johnson, GlaxoSmithKline, and DuPont Pharmaceuticals. His current, ground-breaking work includes a medical device facility at Abbott Laboratories, and a Cyber Engineering Center at the United States Military Academy. | |
| Attendee registration opening January 28! |
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