| Cliff Berry Associate Director of Human Performance Biogen Clifford Berry is currently the Biogen North American Region Human Performance Lead. Berry has been working in the area of human performance for the last 18 years. Following his service in the United States Navy Nuclear Propulsion Program, Berry worked in the commercial nuclear power industry, where he enjoyed the opportunity of starting up and leading an early Human Performance Program. After leaving commercial nuclear power, Berry has been a practitioner of human performance in the electric and gas utility industry, industrial automation controls industry, and now in biotech. Berry holds a M.S. in Work Environment from the University of Massachusetts Lowell. Berry enjoys working with leaders and teams that are interested in learning how to strengthen the organizational and system-related capacities of workplaces in order to enhance resiliency and improve safety, quality, and reliability. Berry finds energy in mentoring investigators, facilitating learning teams, and through the journey of leaders discovering that workers create safety in complex socio-technical systems. Clifford Berry lives in Apex, North Carolina and continues to be connected to northern New England which was his home for many years. | |
| Sheron Branham Associate Director, ASO Process Engineering and Manufacturing Biogen Sheron Branham is the Associate Director of Process Engineering and Manufacturing at Biogen and is responsible for the operation of their new antisense oligonucleotide clinical and commercial manufacturing facility. She serves on the site leadership team for Biogen’s RTP facility and has been at Biogen for about five years. Sheron has almost twenty years of experience in the pharmaceutical industry with the majority of her career in small molecule drug substance and drug product manufacturing for companies like Merck and Glaxosmithkline. She transitioned into oligonucleotides about two years ago to lead the startup of Biogen’s first internal ASO manufacturing facility. She holds a Bachelor’s in Chemical Engineering from Clemson University and is currently an MBA Candidate at NC State University. | |
| Greg Bunting, CXSF Executive Director Indegy Greg Bunting is an Executive Director at Indegy with over 15 years of experience in industrial control systems and cybersecurity. Greg is a graduate of Lehigh University with a degree in Industrial Engineering and earned an MBA from Georgia State University with a concentration in Information Systems. Before joining Indegy, Greg worked with industrial manufacturing and infrastructure clients including large and small pharmaceutical manufacturers. He has augmented that experience with positions in IT and ICS focused cybersecurity at Thomson Reuters and Invincea. Greg will talk about the challenges in protecting industrial controllers (PLCs, RTUs and DCSs) and both the operational and security benefits of properly designed monitoring solutions. | |
| Brian Cail Energy Services Project Manager Duke Energy Standby Diesel Power Generation Program Manager of a fleet of utility owned emergency power systems installed at utility customer’s facilities. Involved in all aspects of the Premier Power Service – sales, engineering, construction, startup, commissioning and O&M. | |
| Michael Childs Project Manager II Duke Energy Michael's talents are critical to Duke Energy's project management team. Michael has responsibility for the design of electrical distribution and emergency power generations systems for industrial and commercial facilities. | |
| Aaron Conant Associate Director Automation Alnylam Aaron graduated from the University of Maine, BS Chemical Engineering in 1994, starting his career at the Foxboro Company focused on Pulp and Paper, Power and Utilities DCS installations. After working for International Paper and MeadWestvaco, he transitioned into life sciences working for Biogen and Amgen prior to joining Alnylam Pharmaceuticals in 2016. Aaron was hired lead Instrumentation and Controls work streams working closely with Jacobs Engineering on design, and Gilbane on construction of the new facility, and is responsible for all Automation system selections, implementation and lifecycle ownership. | |
| Marc Connelly Business Solutions Manager Duke Energy Marc Connelly is Strategic Customer Solutions Manager at Duke Energy. He is focused on helping large industrial, commercial, and institutional clients across the US implement financial and technical solutions that deliver lower risk, higher resiliency and sustainability. These solutions create energy value through innovation, timeliness, outstanding execution and customer service. Marc holds a BS in Biosystems Engineering and a Masters in Business Administration from Clemson University. | |
| Maryann Cuellar Life Science Product Manager Kaiser Optical Systems, Inc. Maryann Cuellar is the Product Line Manager for Life Sciences Industry at Kaiser Optical Systems, Inc. She has been providing application support for pharmaceutical implementation of Raman spectroscopy for over 10 years at Kaiser with recent years devoted to advancing bioprocess applications of Raman. She holds a Master of Science Degree in Analytical Chemistry with a research focus in chemometrics and process analytical technology. | |
| Juan Cueva Downstream Process Development Scientist Biogen Juan Cueva is currently a Downstream Process Development Scientist with Biogen at their Research Triangle Park (RTP) facility in North Carolina. He has over six years of experience collaborating with multidisciplinary teams in the biopharmaceutical industry incurring in areas such as technology transfer, bioprocess design, scale-up and optimization, and sensing and control of upstream and downstream unit operations. Lately, he has been involved with high throughput technologies to accelerate and improve process development efficiency ahead of clinical production. Juan obtained his Bachelor of Science degree from Escuela Politécnica del Ejército (ESPE) in Ecuador. Then, he was awarded a National Science Foundation Fellowship to complete his Master of Science degree in Biomanufacturing at the Golden Leaf Biomanufacturing Training and Education Center (BTEC), NC. | |
| Hadassah Eley Investigator II Biogen Hadassah uses root cause analysis methods recognized across many safety and technical industries in order to determine the root cause for atypical events that occur in Biogen's Manufacturing facilities. She uses her experience working with pharmaceutical utilities, drug substance and drug product (Formulation/Filling) to support Manufacturing in selecting robust corrective actions that address the true root cause or the mitigates recurrence by removing contributing factors. Prior to her current role, Hadassah was a part of the Manufacturing Technical Operations team at Biogen; working with Tech Transfer, Manufacturing Science, and Manufacturing groups to author Batch Records and other manufacturing documents. Hadassah has prior experience from Merck where she worked in Quality Assurance for 5 years, then in Operations as a documentation specialist. Hadassah holds a B.S. Degree in Pharmaceutical Science from North Carolina Central University and a certification as a Project Management Professional from PMI. She also earned her Green Belt Certification during her time at Merck. | |
| Earlene Gibbons Senior Director, Operational Technology United Therapeutics Earlene Gibbons has spent more than 30 years in the technology field and possesses a broad range of experiences in electronic warfare, satellite video conferencing, business intelligence, operations, manufacturing and automation systems. For the last 18 years, she has focused solely on pharmaceutical and biotechnology automation technology. She leverages her subject matter expertise, project management skills and business acumen to help solve complex business problems in collaboration with other business units. Her current responsibilities include the planning, implementation and ongoing support of all GxP systems. Current projects include the corporate serialization/ePedigree effort and the GxP systems harmonization across the corporation. She received a Bachelor of Science in information technology and is a member of the Project Management Institute (PMI). | |
| Chris Grove Director of Industrial Security Indegy With more than 25 years of experience in the cyber-security industry, Chris Grove is the Director of Industrial Security at Indegy, the market leading industrial security solution for mission-critical infrastructure. Previously, he spent 9 years at Imperva during which time he participated in many of their largest, most critical, and complex security projects for many of the world’s largest companies and organizations in practically every industry sector, as well as governments, defense, law enforcement and the IC. In the 90’s, Mr. Grove provided security expertise to the casino industry for 7 years, and even earlier to a long list of Fortune 50 companies ranging from telecom to banking to transportation. Resultantly, Mr. Grove has spoken at security events such as BlackHat, RSA, Infosec, Gartner and other industry events on topics such as cloud security, hacking, cyber-defense strategies, advanced cyber-attack mitigation, regulations, and compliance mandates. Mr. Grove holds a CISSP and is accredited by the National Security Agency (NSA-IAM). | |
| Wendy Haines PHD Associate Director of Scientific and Technical Services PharmEng Technology Wendy Haines has 20+ years of experience in both the research and biopharmaceutical arenas, encompassing toxicology, process design, analysis, validation, project/protocol management and scientific writing. She has successfully integrated herself in both the research and commercial areas of business. Dr. Haines has been a long standing member and active participant within ISPE and has held integral roles of responsibilities that have helped shape our local, national and international rules and guidelines and she is currently the CaSA Chapter President. | |
| Ashley Harp Lead Process Engineer CRB Ashley Harp, PE is a lead process engineer for CRB where she provides process design and implementation services to pharmaceutical and biotech manufacturers. She joined CRB in 2007 and has since worked closely with process owners to lead a range of phases of project design—from feasibility through equipment start-up and validation. Ashley has led an international team through design, operability assessment, construction and mechanical/functional testing of process equipment. Prior to joining CRB, Ashley held positions at Mallinckrodt (formerly Tyco Healthcare) and Unilever. She attended Rensselaer Polytechnic Institute for her Bachelor of Science in chemical engineering and earned her professional engineer’s license in 2012. | |
| Timothy Howard, CPIP Vice President Commissioning Agents, Inc. Timothy P. Howard, CPIP, PE is a Vice President at Commissioning Agents, Inc. and President of DataVoke, Inc., a wholly owned software company of Commissioning Agents, Inc. Tim was formerly responsible for Global Operations Management and VP of Strategic Development for CAI, and continues to consult globally on a range of topics for the biopharma industry including quality risk management, Project Management, C&Q program implementation, and risk-based validation programs. Mr. Howard has been on the International Board of Directors at ISPE since 2011. An ISPE Member since 1994, his service to ISPE includes Past Chair of the ISPE University Committee, Co-Chair of the C&Q CoP, and CaSA Chapter Board member. He was a long-time member of ISPE’s Continuing Education Committee, having served as Chair and Co-Chair for three years. Mr. Howard was a member of the ISPE Task Team that developed the ASTM standard E2500 and a contributing author to ISPE Guidance Documents on ASTM E2500 Implementation. He is a qualified trainer for the ISPE training course on C&Q applications, regularly speaks at conference seminars worldwide, and is published in Pharmaceutical Engineering. Tim previously worked with Eli Lilly, is a former naval nuclear submarine officer, and was previously licensed as a senior reactor operator on a commercial nuclear power plant. Mr. Howard earned a B.S. degree in Mechanical Engineering from N.C. State University, is a Certified Pharmaceutical Industry Professional, and a licensed Professional Engineer in North Carolina. | |
| Jeff Kaminski Associate Director of EHS Biogen Jeff Kaminski has approximately 18 years of Environment, Health, Safety, and Sustainability (EHS+S) experience and currently is an Associate Director, EHS+S at Biogen, headquartered in Cambridge, Massachusetts. In this role, he is responsible for oversight of the Industrial Hygiene and Occupational Toxicology functions for the company. Prior to Biogen, Jeff served as the Associate Director, EHS for Bristol Myers Squibb. In that capacity, he led the EHS department at their Global Product Development and Supply facility in Devens, MA and previously as Program Manager overseeing the industrial hygiene, process safety, and technology transfer programs at the facility. He has held both site and corporate EHS positions at Amgen and has worked as a consultant providing EHS and loss prevention support to industries including biotech/pharma, academia, high tech, and traditional manufacturing. Jeff holds a B.S. in Environmental Health from the University of New England and an M.S. in Occupational Safety and Health from Columbia Southern University. He maintains board certification in Industrial Hygiene with the American Board of Industrial Hygiene as well as Occupational Safety from the Board of Certified Safety Professionals. In his spare time, he and his wife enjoy watching and coaching their 2 children play soccer and vacationing on any beach. Jeff is a New England Sports fan and occasionally sneaks off to play golf. | |
| Gaby Koren VP Americas Indegy Gabriela (Gaby) joined Indegy to manage the Americas Sales operation. Gaby brings to Indegy over 20 years of international experience in sales, business development, alliances management and field marketing in Enterprise markets. Prior to joining Indegy, Gaby was Executive VP at Panaya, an Infosys company, responsible for the success and growth of the Americas markets. Under her leadership, the company experienced exponential growth and success. Before Panaya, Gaby was General Manager for North America for Radvision, an Avaya company, a leading provider in advanced Video Conferencing solutions for the enterprise. Gaby joined Avaya from NICE Systems (Nasdaq: NICE), where she held various senior positions, among them Heading the Global Alliances and Partners team, VP Sales for Asia Pacific and VP Sales of CALA (Caribbean and Latin America). Gaby holds a BA in Behavioral Sciences from the College of Management in Tel Aviv and an Executive MBA from Kellogg school of management of Northwestern University in Chicago. | |
| Paul Kubera Vice President, Process Technology ABEC Paul Kubera is Vice President, Process Technology for ABEC, Inc., a designer and manufacturer of bioreactor, fermenter, product recovery and associated systems for the biotech and pharmaceutical industries. Paul brings over 30 years of experience in process and product development, project management and technology transfer to ABEC’s Services team. Before joining ABEC in 2003 he led Lightnin’s application technology and mixing research groups. With a background and on-going involvement in biological processes, he has been instrumental in providing clients with improved knowledge, understanding and performance of the mixing-related operations that lie at the heart of microbial reactor systems. Paul is an active member of ASME BPE sub-committees, task groups and technology transfer course offerings on bioprocess equipment design, working to translate industry needs into relevant standards and delivering this information to a global audience. He is a member of the North American Mixing Forum and has been a presenter and session co-chair at AIChE technical meetings. Paul is a graduate of Cornell University with a Bachelor of Science and Master of Engineering in Chemical Engineering. | |
| Dean Landers Mechanical Engineer CRB Dean Landers is a mechanical engineer at CRB where he designs HVAC, utilities and process utility systems for the biotech and pharmaceutical industries. After a successful career as a high school science teacher, he helped launch CRB’s Atlanta office in 2013 and has since been involved in a variety of projects, including the design of large, new manufacturing facilities, renovation of manufacturing spaces, construction management, start-up support and full-time engineering augmentation. In addition to his role as an engineer, Dean is also involved in business development, recruiting and employee development at CRB. Dean earned his Master of Arts in science education from Georgia State University and Bachelor of Science in mechanical engineering from Georgia Institute of Technology. | |
| Morgan Malick Process Engineer CRB Morgan is a Process Engineer at CRB with over two years of experience. He is a graduate of North Carolina State University with a degree in Chemical and Biomolecular Engineering and a minor in Biomanufacturing. During his career, Morgan has participated in the design and construction of multiple biotech facilities. Morgan is developing a specialty in downstream processing, single use technologies, and process simulation. | |
| Ingrid Marshall Project Manager Avid Solutions Ingrid Marshall has been in engineering for more than 25 years concentrating on life sciences automation technology and has a broad range of experience in automation system architectural design, implementation and strategic planning. She leverages her broad subject matter expertise to develop solutions that fit the projects and clients’ requirements, and project management skills to execute projects to successful completion. She has been a Project Manager with Avid Solutions, Inc. for 5 years. Her previous experience is the design of automation systems for R&D facilities including pilot plants and scale ups over an 11-year period, and was a lead project engineer for an international company designing large pharmaceutical facilities. She has a Bachelor of Science in Computer Engineering & Computer Science Scientific Systems, and has completed post Baccalaureate studies in Biochemistry, Genetics, Microbiology, and Virology. | |
| Edwin Martinez Matta Senior Engineering Manager Baxter Healthcare Engineering Professional and Subject Matter Expert. With over 20 years of manufacturing operations experience in the development, integration and the support of automated processes, in combination with his BS on Electrical Engineering with a concentration in controls and mechatronic. For the past 10 years, he has supported numerous projects at several of the company facilities, for the integration and qualification of new automated systems, applied to most of phases of the manufacturing process; filling, sealing, inspection, serialization, and finishing and packaging equipment. He is currently a task team member for the company Visual Inspection and Packaging CoP’s (Community of Practice). | |
| Paul McKenzie, PhD Executive Vice President, Pharmaceutical Operations & Technology Biogen As Executive Vice President of Pharmaceutical Operations & Technology, Dr. McKenzie leads Biogen’s organization responsible for asset management, technical development, global manufacturing, supply chain operations, quality, and engineering. He also oversees the construction and operation of the company’s advanced biologics manufacturing facility in Solothurn, Switzerland. Dr. McKenzie’s role places him at a key intersection of Biogen’s commitment to being a pioneer in neuroscience. Dr. McKenzie will showcase the innovation taking place at Biogen and in the greater pharmaceutical community and present how these efforts are positively impacting patients around the world. In his keynote, he will share insights into what drives innovation in the pharmaceutical industry and discuss the path Biogen is taking to ensure global availability of current and future therapies. | |
| Glen McVay Principal Engineer Grifols Lead electrical engineer responsible for the coordination of power services for the Grifols North Carolina Area sites as well as providing support to the Grifols Los Angeles California sites as needed. An active ISA and NFPA member serving on ISA’s CCST Program Development group with 27 years’ experience in the design, maintenance and power distribution areas. | |
| Aaron Mertens Technical Service Specialist STERIS Aaron Mertens has been a member of the STERIS Life Sciences Contamination Control Solutions team as a Technical Service Specialist since January 2015. In this role, Aaron has responsibility for providing global technical support primarily for Critical Environments, Sterility Assurance and Barrier Products, application and validation. Previously, for 7 years Aaron was the US Technical Manager for Atec Sterile Technology USA, a partner of Atec Pharmatechnik, Germany. For Atec USA, he was responsible for providing technical support for new and existing sterilization systems. This included project management, equipment commissioning, qualification, maintenance and troubleshooting. Also, while at Atec, Aaron managed the Commissioning and Qualification Program by maintaining standards, procedures and testing methods. Prior to that, Aaron spent nearly 10 years at Pfizer in Kalamazoo, MI. At Pfizer, he specialized in sterilization validation of autoclaves, dry heat ovens / tunnels, freeze dryers and stopper processors. Additionally, he gained experience interfacing with industry regulatory agencies (FDA, EMEA, Japan), representing validation programs for steam, dry heat, vapor phase hydrogen peroxide and irradiation sterilization processes. Aaron has been a member of ISPE and PDA since 1999, contributing by presenting posters and talks at meetings, as well as participating in local chapter functions. He holds a bachelor’s degree in Genetics from the University of Wisconsin – Madison. | |
| Brandon Moore Development Engineer Biogen Brandon Moore is a process development engineer at Biogen in RTP, NC focusing on cell culture process development. He has a Masters in Upstream Biomanufacturing from NC State and 8 years of experience with biopharma-focused cell culture systems including automation and feed strategy design. | |
| Tolga Musa Associate Director of Process Engineering Biogen Tolga is the Associate Director of Process Engineering at the RTP, NC facility. Responsible for management of all process equipment and auxiliary equipment systems from a technical support perspective – including change control, startup/commissioning, and troubleshooting. Tolga is Lead & SME for process engineering equipment aspects during compliance or regulatory audits and filings at RTP DS site, and follow-up action plans for equipment-related responses. Tolga has been with Biogen since 2005; with experience at other pharmaceutical companies before then. Tolga holds a Chemical Engineering degree from the Georgia Institute of Technology and a Master’s degree in Business Administration from the University of North Carolina. | |
| Carl Newberg Senior Applications Engineer Simco-Ion Carl Newberg is a Senior Applications Engineer with Simco-Ion, an ITW Company, developing ionization solutions for the Life Science sector of High Tech manufacturing. Carl is also the President of MicroStat Laboratories/River’s Edge Technical Service, a static control testing and consulting firm. He has a B.S degree in Metallurgical Engineering, a M.S. Degree in Materials Science, and a professional engineer’s license (Met. Eng.). He is also an iNARTE Certified ESD Engineer, and is one of the first to test and receive certification from the ESDA as a Certified ESD Program Manager. He has held positions as the ESD Program Manager for Western Digital Corporation, and has been actively involved in the corporate ESD program at Seagate Technology and IBM Corporation. Carl has been a member of the ESD Association since 1995. He was a Board member from January, 2005 until March, 2011, and was the Technical Program Committee Chairman for the 2004 EOS/ESD Symposium, Vice Chairman for the 2005 Symposium, and General Chairman for the 2006 Symposium. Carl recently stepped down as the Standards Committee Chairman, overseeing standards development for the ESD Association. He has co-taught the 2-day ESD Program Development & Assessment (ANSI/ESD S20.20 Seminar) tutorial, the 2-day ESD Essentials Seminar, and the one-day “How-To’s of In-Plant ESD Control” and also a tutorial on “Electrostatic Attraction” for the ESD Association. He is co-author of Contamination and ESD Control in High Technology Manufacturing, a book published by John Wiley & Sons. | |
| Lars Olsen Global Technology Partner NNE Lars Olsen has more than 20 years of experience from operations and project execution within the pharma, biotech and medical device industries. His primary focus is on packaging and counterfeit studies, and he is a leading expert in pharmaceutical packaging processes. He is involved in projects for pharmaceutical companies worldwide within packaging processes, counterfeit, assembly and medical devices. Lars has been a steering committee member of the ISPE society since 2005 and Facilitator of ISPE COP for Pharmaceutical Packaging. With a background in machine construction engineering and years of manufacturing experience, he bridges the gap between design and execution, applied in numerous conceptual design and optimisation assignments. Furthermore, his broad experience has given him a unique ability to align engineering solutions with overall efficiency and performance goals. He is an experienced user representative and process responsible with a strong focus on optimal solutions for a well-running production. | |
| Roger Paules Sr. Marketing Manager Duke Energy A seasoned energy executive, Roger began his career as a distribution engineer and has worked in nearly every facet of the industry including industrial sales, strategic planning, demand response and marketing. He is an active professional in the utility industry, serving with distinction on committees for Advanced Energy, the Department of Energy, and the Electric Power Research Institute (EPRI). He traveled internationally on behalf of EPRI, consulting with several national governments on power generation and delivery. His current work focuses on creating awareness and tools for the delivery of custom solutions to help commercial, institutional and industrial customers. | |
| Thien Pham Site Engineering Pfizer Thien Pham has more than 20 years of manufacturing operations experience in Electronic Manufacturing Services and Pharmaceuticals and Medical Device Manufacturing in combination with a Bachelor of Science in Electrical and Computer Engineering. His area of expertise includes production, maintenance, and engineering. He further has significant experience with most phases of manufacturing including filling, sterilization, visual inspection, packaging, and utilities. For the past 10 years, Thien has designed, developed, implemented, and managed multiple major capital projects at different facilities. The projects included a new packaging facility, multiple automated visual inspection lines, a SCADA system for product autoclaves, a steam plant, and a new sterile filling facility. | |
| Paul Richards Principal, Process Engineering Biogen Paul Richards is a Principal Process Engineer for Biogen Global Process Engineering. In this role, Paul provides process engineering technical leadership and expertise to small molecule facility and manufacturing projects. He is also responsible for providing Due Diligence and technical support for external Drug Substance, Drug Product, and Finished Goods manufacturing operations. Paul has more than 30 years of progressive experience in the successful implementation of capital and technology projects in the Pharmaceutical and Fine Chemical Industries. Prior to joining Biogen, Paul’s professional experience included technical leadership positions with CRB Consulting Engineers, Pfizer, James Chemical Engineering, and John Brown Engineering & Construction. Paul has been an active member of ISPE through the years as a past Board Member and Officer for the New England Chapter of ISPE and a Steering Team Member of the ISPE’s API, OSD, and Containment Community of Practices. | |
| Jamie Sigmon Associate Scientist III Biogen Jamie Sigmon is an Associate Scientist III in the Technical Development department at Biogen. In her current role, she specializes in fill/finish and lyophilization process development for biopharmaceuticals. Jamie has additional work experience with process development and cGMP manufacturing in upstream and downstream operations. Jamie has a Bachelor’s degree in Biochemistry and a Master’s of Science degree in Upstream and Downstream Biomanufacturing from North Carolina State University. | |
| Josip Simunovic Research Professor North Carolina State University Josip Simunovic is a Research Professor of Food Science at North Carolina State University (NCSU). His interests include continuous flow thermal heating, pasteurization and sterilization, advanced thermal processing, microwave-assisted processing, particle flow monitoring and process validation in multiphase aseptics, temperature and lethality measurement and validation, advanced continuous flow cooling. He has earned numerous academic awards and authored many highly acclaimed industry publications Over the years Josip has split his time between Florida, North Carolina, and Croatia. A graduate of the Unversity of Osijek (Croatia), he earned his M.S. in Food Science and Human Nutrition from the University of Florida (Gainsville) in 1983, and his Ph.D. in Food Science from NCSU in 1998. | |
| Chris Small, PE Principal Clark Nexsen Chris Small is the market leader for Clark Nexsen's Science + Technology practice that has designed more than 3.5 million square feet of research and development space since 2010. His expertise is focused on project management, client management, and business development where he excels at communicating with client teams to move projects forward. Chris has served as a leader on multiple research and development greenhouse projects throughout the U.S. Additional project experience includes research and biomedical laboratories for pharmaceutical, higher education, agricultural technology, industrial, warehousing, and manufacturing facilities. | |
| David G. Smith Talent Acquisition Lead - PO&T North America Biogen | |
| 0 | Angela Swain Sr. Manager Quality - Steriles Thermo Fisher Scientific - Patheon coming soon |
| Emily Thompson Process Engineer CRB Emily is a Process Engineer at CRB with more than fifteen years of process engineering experience. A specialist in process simulation and modeling, she is an active member of CRB’s Simulation Expert Team and is serving as the team lead in 2016-2018. On client projects, Emily often fills the role of Process Engineer and provides innovative design solutions to solve manufacturing challenges. Emily’s project work includes a variety of clients in the Carolinas, including Seqirus, Biogen, and Pfizer. She is also an active member of ISPE. A graduate of North Carolina State University, Emily holds two degrees: BS in Chemical Engineering and BS in Biochemistry. | |
| Rich Tree Vice President Commissioning Agents, Inc. Rich is a hands-on senior consultant with 35 years of experience leading teams to achieve organizational excellence in supply chain management, asset management, reliability, commissioning, and human performance improvement. His leadership has consistently strengthened company’s bottom line because he focuses on improving efficiency and eliminating waste. A trusted advisor, he guides teams to develop unified strategies that ultimately improve their effectiveness through improved organizational management, enhanced human performance, and asset management practices. As a lean operation expert, he is personally credited with the lean transformation of 9 manufacturing sites, mentoring over 34 manufacturing sites in advanced lean operations, and designing and implementing asset management strategies at 15 manufacturing sites. Rich’s personal leadership journey began during his career in the US Navy and has since been refined and developed in several key operations leadership roles in three manufacturing companies and a professional services firm. Rich has the natural ability to immediately see beyond the status quo to assess issues, communicate the vision, and implement long-term solutions that achieve corporate and customer objectives. He is a straightforward communicator who challenges team members to achieve top performance levels. He is currently working toward a PhD in Operations Management at the University of Texas Arlington where his research has focused on Behavioral Operations and Statistics. He holds an MBA from Southern Methodist University and a Bachelor of Science degree from Columbia College. | |
| Natalie Upchurch Manager, EHS Biogen Natalie’s role as Manager of Investigations Team is inclusive of Biogen's RTP Drug Substance and Drug Product site operations investigations. Natalie has demonstrated exemplary leadership; providing coaching and mentoring support to her staff as new causal analysis methods are applied to how we do investigations. Natalie joined Biogen in 2011 and held a variety of management positions in Quality Assurance and Manufacturing Support before joining the investigation team at Biogen. Prior to Biogen, Natalie worked as a Validation Engineer at other pharmaceutical companies. Natalie holds a B.S. in Electrical Engineering from North Carolina State University. | |
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