ISPE-CaSA 2022 Life Sciences Technology Conference
Leyla Avila
Human Resources Director
Leyla Obenza Avila is the Human Resources Director at Abzena’s newest site at Sanford, NC. What excites her in this role is the opportunity to shape, foster, and sustain a culture that centers around employees, partners, and patients. She believes that investing in an environment that allows to amplify moments that matter to employees will truly spark innovation, creativity, and an unlimited organizational performance for Abzena that will also lead to great returns for partners and patients. Having played several cross-functional roles across different industries and organizations, her biggest learning is that human connection and empathy are key to building a resilient, agile, and engaged workforce. Leyla specializes in Strategy, HR, Communications, Operations, and Program Management; and has worked at Roche, Blue Shield of California, Xerox, and the California Primary Care Association. She has an MBA in Finance from Golden Gate University and a BS in Applied Economics from De La Salle University. She is also Project Management Professional certified.
John Batts
Senior Technical Trainer
John W. Batts IV is a Senior Technical Trainer for Avantor. For the past 30 years, John has worked professionally in the laboratory science market in a variety of capacities. John joined Avantor through the Masterflex® acquisition in November 2021 and serves as a technical product trainer. He holds a dual Bachelor’s Degree in Chemistry and Mathematics from Lindenwood University.
Eric Bennett
Key Segment Manager - Pharmaceuticals and Life Sciences
Duke Energy Sustainable Solutions
Eric Bennett is the Key Segment Manager for the Pharmaceutical and Health Care segments at Duke Energy Sustainable Solutions. He specializes in guiding customers through retail energy markets, distributed generation and renewable and sustainable energy solutions. With 20 years of experience developing power security and resiliency projects, Eric has seen and helped solve many challenges. Over the years, he’s worked with Novo Nordisk, Fujifilm Diosynth, General Motors, Archer Daniels Midland Company, and Kraft Foods. Eric is a graduate of Northwood University with a Bachelor of Business Administration.
Andrew Campbell
Senior Manager, Corporate Real Estate
United Therapeutics
Andy is a construction and real estate development professional focused on leading edge sustainable design and construction within the Life Science sector.
David Davis
Head of Site Engineering, RTP Pharma
David Davis currently serves as the Head of Site Engineering for Biogen's RTP Pharma Site. He has been with Biogen for 17 years has held increasing roles of responsibility in Biogen's engineering organization. David continues to be actively engaged in ISPE-CaSA and has previously served as Director-at-Large. He holds a Bachelor's degree in Chemical Engineering from Vanderbilt University.
Leigh Fultz
Chief People Officer
FUJIFILM Diosynth Biotechnologies
As the Chief People Officer, Leigh Fultz has a responsibility for creating and overseeing FDB's Global Organization and Cultural Development initiatives, providing pan-FDB support and focus on creating the organization that establishes FDB not only as an industry-leading CDMO, but also widely recognized as "a great place to work". In her prior role as responsible for HR, EHS, and Training at our North Carolina site, Leigh established, oversaw, and led a number of programs, processes and initiatives benefiting and dedicated to our most important asset: our people. Leigh joined the company in 2001 and grew into the role of Director, Human Resources, and supported the journey through acquisitions and change. In addition to the extensive experience from working in different areas focusing on people and culture for companies such as Merck and LabCorp, Leigh has also a background in science - a degree in biology from the University of North Carolina in Chapel Hill, which ultimately led her into scientific recruitment and to FDB.
Jeff Hall
Human Performance Associate Director
Jeff Hall is an Associate Director in Human Performance services with over 30 years of experience with implementing programs to support the start-up, operation, and maintenance of process systems and equipment. He has over 20 years of experience managing projects of up to $125M and leading groups of people ranging from one to over 25 persons. Jeff has an MBA and is an expert in Training Development and Project Management. He uses the skills in these two areas to manage project costs and efficiency. He has used this approach to create focused, effective, and efficient organizations and successful project implementation. He is experienced in auditing, developing programs, and leading projects in GMP, GLP, and GCP environments.
Kimball Hall
President and COO
Kimball Hall serves as Abzena’s President and COO at Abzena. Kimball is accountable for all operations across the company and is a member of Abzena’s Board. Abzena is a Partner Research Organization delivering integrated outsourced discovery, development, and manufacturing to the Biologics and ADC industry. Kimball has more than 30 years in Commercial Operations with senior leadership roles in Manufacturing, Quality, and Regulatory Compliance. She has a wide range of experience in developing, licensing, and supplying Biopharmaceuticals for global markets.
Adam Hughes
Sales Development Manager - Temperature & Systems
Adam Hughes is the Sales Development Manager at Endress+Hauser Temperature and Systems Products. He has responsibilities for the strategic direction of the temperature business unit including the product portfolio management, technical and application support, along with marketing and business development for temperature and systems products. Adam attended the University of North Carolina at Charlotte and has over 10 years of experience in temperature measurement instrumentation.
Sid Jain
Supervisor, Manufacturing Projects
Sid is a biotech professional with 6+ years of process development and manufacturing experience. He has a MS in Biomanufacturing from NC State University and an engineering degree in Biotechnology from VIT University, India. He is passionate about people leadership, continuous improvement, and lean manufacturing.
Natacha Janvier
Membership Director
NCBIO - The NC Biosciences Organization
Natacha Janvier received her BS Degree in Biology coupled with an AS degree in Criminal Justice from Grambling State University and Master’s Degree in Zoology from Michigan State University. As Director of Member Services at NCBIO, Natacha handles member recruitment, retention, sponsorships and general services for NCBIO members. Natacha came to NCBIO from Eva Garland Consulting (EGC) where she was the Business Development Coordinator. Before that, she was with NCCU’s BRITE program for more than 14 years as a senior academic advisor and science recruiter, for both undergraduate and graduate students, in the Department of Pharmaceutical Sciences. She also spent more than seven years as an associate scientist at GSK, where her contributions to early phase drug development in the Cloning and Expression and Genomic Histology groups were recognized.
Faryal Khan
Process Engineer
DPS Group
Faryal Khan is a process engineer with over 7 years of experience in the pharmaceutical industry. She holds a Chemical Engineering degree from North Carolina State University and has experience in designing and coordinating both small- and large-scale projects ranging in cost from $50,000 to $10,000,000. Faryal constantly seeks to understand the impact of new and developing trends in the biotech and pharmaceutical industries, leveraging these innovations for her clients’ cutting-edge projects.
Rick Lawless
Workforce Development Director
NC Biotechnology Center
Rick has worked in the life sciences sector for over 36 years. Prior to joining the North Carolina Biotechnology Center as Workforce Development Director in December 2021, Rick led the manufacturing training and development team at KBI Biopharma and was responsible for the design, registration, and launch of the KBI Manufacturing Apprenticeship Program. Rick also developed talent at AveXis/Novartis Gene Therapies and NC State’s Biomanufacturing Training & Education Center (BTEC), which he helped start up in 2006. Before entering the workforce development space, Rick managed GMP manufacturing groups at Eastman Kodak (industrial fermentation products), Johnson & Johnson (clinical diagnostics), and Wyeth (vaccines) for more than 20 years. He earned BS and BSE (ChE) degrees from the University of Michigan, an MBA degree from SUNY Buffalo, and his CPIP credential from ISPE.
Loren Limberis
Associate Professor of Engineering
East Carolina University
Loren Limberis, PhD is Associate Professor, Bioprocess Engineering Concentration Coordinator and Director, Eastern Region Pharmaceutical Center in the Department of Engineering at East Carolina University.
Alex Lopez
Sr Quality Associate
Alex Lopez is a Senior Quality Associate within the Biogen Quality organization, based in RTP, North Carolina. Mr. Lopez’s has a career foundation in risk management, IT compliance, data integrity, computerized systems validation, equipment commissioning and qualification. He has worked for several regulated companies from large multinational pharmaceutical firms to small consulting enterprises. He is a career life sciences professional with over 25 years of experience in Quality, Engineering and Validation. Mr. Lopez is a current member of ISPE’s Carolina Chapter and an active member of the Society of Hispanic Professional Engineers (SHPE). Mr. Lopez holds a B.S. in Chemical Engineering from Lehigh University.
Dean Mattiace
Facility Operations Director
Dean Mattiace is the Facility Operations Director for Biogen at the Drug Substance manufacturing site in RTP, NC. Since graduating from the New York Institute of Technology, Dean’s experience has been focused in the design, construction, and operation of production and research equipment, systems, and facilities. This work has provided Dean the opportunity to stand on the deck of a nuclear powered aircraft carrier, to stand under a wing of the space shuttle, and to travel to many exciting destinations. The majority of Dean’s career has been in the Bio/Pharma field where he has contributed to the development and production of numerous life changing therapies.
James Menke
Director, National Security Initiatives
East Carolina University
James R. Menke is a Master Chief in the United States Navy (ret.), and Director, National Security Initiatives in the Office of National Security and Industry Initiatives, Division of Research, Economic Development and Engagement at East Carolina University.
Brad Mickey
Associate Director, Head of Manufacturing
Astellas Gene Therapies
Brad joined the Astellas Gene Therapies team soon after the company purchased and broke ground in Sanford’s Enterprise Park. To date, the Sanford site has been focused on the completion of the first phase of its future commercial manufacturing facility as well as attracting and hiring talented resources to join their team. The Sanford site will be dedicated to manufacturing late-stage clinical and commercial vector gene therapies using suspension-based technologies. Brad has accumulated over 18 years of experience working with various pharmaceutical organizations specialized in biological drug substance manufacturing operations. Employed within both engineering and manufacturing leadership roles, he has been exposed to the challenges as well as successes associated with designing, commissioning, and maintaining these complex facilities. Brad has both a bachelor’s degree in Chemical Engineering and a master’s degree in Business Administration from NC State University.
Steve Milford
Product Business Manager - Flow
Steve Milford is a Sr. Flow Product Business Manager at Endress+Hauser. He has responsibilities that include technical and application support, along with marketing and business development for the US Southeast region. Steve has over 42 years’ experience with process instrumentation and automation, with 15 years specializing in flow measurement at Endress+Hauser. In the late 1990s his reputation helped him to gain acceptance to the British Standards Institute (BSI) and later the International Standards Organization (ISO) Committee ISO TC30/SC5 for velocity and mass-based flow measurement methods. He has been a major contributor to the development of several published standards emanating from both the BSI and ISO.
Tolga Musa
Director, Manufacturing
Tolga Musa is the Head of Manufacturing for Small Scale Manufacturing and Flexible Volume Manufacturing at Biogen's RTP site. Tolga has over 26 years of experience in the pharmaceutical industry. Over the last 17 years, Tolga has held leadership roles across Biogen's manufacturing, engineering, and validation functions. Tolga is a previous Director-At-Large for ISPE CaSA. He is currently a sponsor for the Fit for Manufacturing (FFM) team at Biogen working to design and implement a complex strategy for maintaining equipment and facility readiness. Tolga holds a Bachelor's of Chemical Engineering from Georgia Institute of Technology and an MBA from UNC.
Jeffery Odum CPIP
Practice Leader, ATMPS & Biologics, Genesis AEC
Jeffery Odum, CPIP is a globally recognized SME in the Biotech Industry, with over twenty-five years of management experience in the design, construction, and start-up of facilities in the biotechnology and pharmaceutical industries. A recognized expert in biopharmaceutical manufacturing, Jeff has authored over eighty articles and four Industry reference books on subjects related to project management, GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities. Jeff is a Certified Pharmaceutical Industry Professional (CPIP), is the Chair of the ISPE global Biotechnology Community of Practice, and is a member of the PDA and ISPE technical training faculties. He is a Teaching Fellow in North Carolina State University’s BTEC graduate program in biomanufacturing. Jeff has led training efforts in fifteen countries, including training for global regulators from the US FDA, Health Canada, and the Chinese SFDA. Jeff holds a Master's Degree in Engineering from the University of Tennessee and a B.S. Degree in Mechanical Engineering from Tennessee Technological University.
Mike Perkins
Sr Manager, Manufacturing Technical Operations
Mike Perkins is the Senior Manager of the Manufacturing Technical Operations team with over 13 years of manufacturing, technical operations, and engineering experience at Biogen. He currently leads a team of Manufacturing Specialists who develop and manage process instructions and manage commercial and clinical products by executing technology transfer. Other team responsibilities include continuous improvement, change control, CAPA’s, and project management for operations related efforts within large scale drug substance manufacturing. He is currently serving on the core Fit for Manufacturing (FFM) team at Biogen working to design and implement a complex strategy for maintaining equipment and facility readiness. Mike received a B.S. degree in Chemical Engineering from North Carolina State University.
Scott Ralls PhD
Wake Technical Community College
Dr. Scott Ralls became the fourth president of Wake Technical Community College in April, 2019. Before coming to Wake Tech, he served as president of Northern Virginia Community College from 2015-2019, president of the NC Community College System from 2008-2015, and president of Craven Community College in New Bern from 2002-2008. He has also worked from the NC Department of Commerce, the U.S. Department of Commerce, and the U.S. Department of Labor. Dr. Ralls earned his bachelor’s degree at UNC-Chapel Hill and master’s and doctorate degrees in Industrial and Organization Psychology from the University of Maryland. He is the recipient of numerous awards, including the Distinguished Public Service Award from the North Carolina Chamber, and the Order of the Long Leaf Pine, North Carolina’s highest civilian honor.
Stephenie Robertson
Vice President, Operations - Engineering, Supply Chain & EHS
FUJIFILM Diosynth Biotechnologies
Stephenie Robertson earned a B.S. in Chemical Engineering from NC State in 1995. After graduation, she received a commission in the US Army as a lieutenant in the Corps of Engineers. Stephenie was stationed at Fort Bragg, NC and deployed to Bosnia as part of Operation Joint Endeavor. While at Fort Bragg, Stephenie was selected to be the first female officer to serve in a Combat Engineer organization, and graduated from Fort Bragg’s Jumpmaster School. After serving in the Army, Stephenie attended the University of South Florida and earned a Master of Science in Chemical Engineering. She began her civilian engineering career as a Process Engineer at Ajinomoto Amino Science in Raleigh, NC, where she held various positions before becoming the Head of Production, responsible for all manufacturing, utilities, wastewater treatment and safety. In 2007, Stephenie joined Novartis Vaccines and Diagnostics to build an influenza vaccine manufacturing facility in Holly Springs, NC, as part of a national effort to improve the United States’ pandemic response. She held various positions in the Cell Culture Manufacturing facility, including Head of Upstream Operations (Cell Culture/Virus Production), before moving to Quality Assurance where she held the position of Director, Quality Assurance Operations under the site’s new owner, Seqirus. In 2018, Stephenie moved to Fujifilm Diosynth Biotechnologies in Research Triangle Park, NC, where she is currently the Vice President of Operations, responsible for Engineering, Supply Chain and Safety.
Bethany Silva
Life Science Industry Manager
Bethany Silva is the Life Science Industry Manager for Endress+Hauser, a globally operating process and laboratory instrumentation and automation provider. In this capacity, Bethany is responsible for the strategic direction, vision, and growth of the Life Sciences Industry.
Chris Small, PE, Moderator
Principal / Science & Technology Market Leader
Hanbury Architecture Planning
Chris Small is the current President of ISPE-CaSA. He has more than 15 years experience in facility design for the Life Sciences Industry. As Principal at Hanbury, Chris is responsible for all design projects and book of business in the Life Science market. Chris earned his B.S. in Civil Engineering from North Carolina State University.
David Smith, Moderator
Head, Global Talent Acquisition
David G. Smith knows a thing or two about talent acquisition and career development in the pharmaceutical industry. Over the last 20 years, he has worked with tens of thousands of job candidates and has been involved in hiring thousands of individuals. Today, as Head, Global Talent Acquisition at Biogen, Inc., David is responsible for talent acquisition for Biogen’s global Pharmaceutical Operations and Technology division. In his role, he has responsibilities for all aspects of talent acquisition from workforce planning, university relations, diversity engagement and ensuring Biogen has access to the best talent available for present and future business needs. Prior to joining Biogen, David held leadership roles at Kelly Services, Health Decisions and US Tech Solutions. For the last 17 years, he has been working in talent acquisition largely supporting organizations in the life science space including functional groups ranging from manufacturing and engineering, commercial, R&D, Quality and general administrative professionals. David has experience working across the entire spectrum of pharma, from interns and new graduates through the VP-plus level, and with companies ranging from two-person startups to some of the largest pharmaceutical companies in the world. David has an undergraduate degree in chemistry from Stephen F. Austin State University in Texas; upon graduation, he served as a chemist in the semiconductor chemical industry. He has served on several boards and committees with organizations such as ISPE, NC Biotech Center, PDA, NC Bio and others. David is active in the community supporting K-12 STEM education efforts.
Adam Tessneer
Associate Director, Quality Engineering
Adam Tessneer is Associate Director, Quality Engineering within the Biogen Global Quality organization, based in RTP, North Carolina. Mr. Tessneer’s career focus has centered on commissioning and qualification, cleaning validation, risk management, data integrity, and facility controls. Prior to his current role, Adam held roles of increasing capacity at multiple companies in Validation, Commissioning and Tech Transfer throughout his more than 20 years working in the Biotechnology, Pharmaceutical and Food Industry.  Mr. Tessneer holds a B.S. and M.S. in Food, Bioprocessing & Nutrition Sciences from North Carolina State University.
Tony Thatcher
Executive Director, MSAT
Istari Oncology
Anthony "Tony" Thatcher started his career in cell therapy working at Dendreon in 2001. He spent over 14 years there, moving from Manufacturing Associate to Sr. Manager of Technical Services, helping develop and launch the first commercial cell therapy, Provenge. Tony then moved for a short time into traditional aseptic fill/finish manufacturing at Luitpold Pharmaceuticals, but returned soon after to cell therapy joining Novartis's Cell and Gene Therapy group as a Tech Transfer Lead. Over his 4 years at Novartis he was promoted to head the Manufacturing Science and Technology team supporting the final stages of development and launch of the first gene-edited cell therapy for Leukemia and Lymphoma, Kymriah. Tony joined Cellectis in 2019 to develop and launch their internal manufacturing facility in Raleigh, NC using an innovative isolator approach to UCART allogenic cell therapy manufacturing. In 2021 he moved to Istari Oncology as Executive Director of MSAT leading development and manufacturing support of lerapolturev, a cancer therapy based on the oral poliovirus vaccine. Tony holds a B.S. in Biology from Gonzaga University and an M.B.A. with a focus on Supply Chain from Rutgers Business School.
Emily Thompson
U.S. Director New Process Technology
DPS Group
Emily Thompson, U.S. Director New Process Technologies, is a process Subject Matter Expert (SME), specializing in biological process and facility design. Over the last 20 years working in the biotechnology industry, she has gained expertise in designing facilities for monoclonal antibodies, vaccines, and novel therapies including cell therapies, gene therapies, and mRNA. A graduate of North Carolina State University, Emily holds two degrees: a Bachelor of Science in Chemical Engineering and Bachelor of Science in Biochemistry. She is also a licensed Professional Engineer in the state of North Carolina.
Tracey Tomchick
Senior Director Engineering
Eli Lilly and Company
Tracey is a Senior Director of Engineering for Eli Lilly and Company accountable for ensuring engineering standards of excellence across the global manufacturing and quality organization. In her role, Tracey has responsibility for the Engineering Technology Center in Indianapolis and for Drug Product manufacturing sites in the USA, Europe and Asia. Tracey has over 29 years of engineering and leadership experience across multiple engineering disciplines and technologies. She began her engineering career with Aker Kvaerner Pharmaceuticals in 1992 as a process engineer, where she participated in design, construction support and qualification for multiple projects across the pharmaceutical and chemical industries. In 2003, she joined ImClone Systems Corporation (now Eli Lilly) and shortly after took on her first leadership role managing process engineering for ImClone’s single train GMP biopharmaceutical facility. During her time in this role, Tracey supported the facility through its first FDA approval and transition into commercial manufacturing. She started a 6-year international assignment at Eli Lilly, Kinsale, Ireland in 2011. Early in the assignment, Tracey played a key role in establishing and growing the biotech large molecule manufacturing business at the Kinsale site. By the end of her assignment, she was the Engineering Business Unit Leader responsible for the entire engineering organization and business at the Kinsale site. In April of 2017, she returned to the USA and transitioned to an Engineering Director role for Indianapolis Parenteral Manufacturing in the drug product network. Tracey led her engineering team in support of the commercialization and supply of insulins products from the site. In this role, she had the unique opportunity to lead the Indianapolis site through a 15-year strategic site master planning exercise. She assumed her current role in 2019 and continues to support engineering and the Drug Product network globally. Additionally, she sponsors the Engineering Staffing Strategy group in Indianapolis whose mission is to recruit, engage and retain top engineering talent for Eli Lilly and Company. Tracey graduated from Bucknell University, Lewisburg, PA with a Bachelor of Science degree in Chemical Engineering in 1992.
Todd Troutman
Engineering Director
Astra Zeneca
Todd has over 35 years of international leadership and technical experience in the bio-pharmaceutical industry. Through his career, Todd has worked for both contractor and owner companies, managing teams to deliver projects and products. Prior to Astra Zeneca, Todd worked for Eli Lilly and Company and Kvaerner Process, delivering projects and process solutions in the US and Europe. Todd is a contributing author, presenter and trainer for many of the ISPE Baseline Guides; and a member of the Local Chesapeake Bay ISPE Chapter.
Shelley Willingham
VP of Business Strategy
The Diversity Movement
Shelley is a serial entrepreneur and business strategist with more than 20 years of corporate and small business experience. In 2003, Shelley founded the National Organization for Diversity in Sales and Marketing (NODSM), a company focused on helping corporate America recognize the increasing purchasing power of diverse segments and helping them market to these groups without using stereotypes or being offensive. In 2006 Shelley partnered with FORTUNE magazine on a special diversity section highlighting her work in this space. Shelley speaks at various business events and conferences, coaches and consults aspiring entrepreneurs and business owners, and is a frequent on-air contributor to CNBC. Shelley leads client acquisition strategy and execution while supporting each of the TDM business units in the development of their respective strategies. Her focus is on enhancing customer value, building competitive differentiation, and driving revenue and profit growth.