Executive Committee
Julie Barberio is the Vice President of Client Solutions at Sequence Inc., a leading provider of commissioning, qualification, validation (CQV), and digital solutions for the life sciences industry. In her role, she provides strategic insight and direction for marketing and business development initiatives, supporting the company's growth objectives. With over 25 years of experience in marketing, public relations, and brand engagement, Julie leverages her expertise to enhance brand awareness and reputation, aiming to reach prospective clients globally and ensure the achievement of long-term growth goals.
Prior to her current position, Julie served as the Director of Marketing at Sequence Inc., where she specialized in marketing strategy, PR and brand engagement, industry partnership management, and cross-functional team relationship building.
Julie holds a Bachelor of Science degree in Marketing from Arizona State University.
John Garner is an engineering and construction professional with a focus on capital project delivery in the life sciences industry. He currently serves as a Project Manager at Process, Automation & Commissioning Engineers, Inc. (PACE), an engineering consulting and construction management firm based in Apex, North Carolina. In this role, John leads PACE’s project delivery efforts, leveraging his background in EPCM project and program management to support clients through all phases of their capital projects—ranging from long-term strategic planning to GMP-ready handover.
Prior to joining PACE Group, Inc, John was a Senior Project and Program Manager at Wood, a global engineering and consulting firm, where he successfully led complex EPCM projects and capital programs for leading biotech and pharmaceutical clients.
John’s expertise spans the full project lifecycle, including front-end design, project execution planning, cost and schedule management, procurement and subcontracting, construction oversight, and commissioning and qualification. He is also passionate about business development and relationship-building, with a strong belief in authentic, long-term partnerships across the industry.
He holds a Bachelor’s degree in Chemical and Biomolecular Engineering from North Carolina State University.
Shannon Manning is the Associate Director of Large Scale Drug Substance Manufacturing Support and Documentation at FUJIFILM Diosynth Biotechnologies (FDB) in Holly Springs, NC. In this capacity, he oversees a team dedicated to transferring knowledge and business processes within the network during the project phase. As the site migrates from project to operations, Shannon’s team is instrumental in supporting manufacturing operations through sustained efforts, including ownership of documentation, recipe configuration, investigation and deviation management, training, and ensuring campaign readiness.
Before joining FUJIFILM, Shannon accumulated a decade of experience with Biogen. Initially, he served as a Downstream Process Tech Transfer Lead before advancing to Manufacturing as a Supervisor. Shortly thereafter, he was selected for the start-up team of Biogen’s greenfield drug substance facility in Solothurn, Switzerland, where he contributed to the project from late construction to PPQ over a span of 3.5 years. Prior to his tenure at Biogen, Shannon played a significant role in the design, FAT, construction, and start-up of the Novartis (now CLS Seqirus) Flu Cell Culture facility in Holly Springs, NC. At Novartis, he supported upstream design as a Production Engineer, oversaw DCS automation design, testing, and start-up as an Automation Engineer, and led the execution of engineering batches as a Downstream Supervisor.
Shannon has been actively involved with the International Society for Pharmaceutical Engineering (ISPE), contributing significantly during his time at North Carolina State University (NCSU). He served as the Secretary (2005-2006) and President (2006-2007) of the NCSU ISPE Student Chapter. After earning his Bachelor of Science in Chemical Engineering, Shannon continued his engagement with the ISPE CaSA Chapter, offering his expertise as an industry advisor to the NCSU ISPE Student Chapter from 2007 to 2014. In 2024, he returned to the ISPE CaSA Chapter board as a Director at Large, a role in which he currently serves.
Chandler Conley serves as the Senior Director of Technical Operations, East Coast at PSC Biotech Corporation. Based in the Raleigh-Durham area of North Carolina, she brings over 13 years of experience in the life sciences industry focusing on Good Manufacturing Practice (GMP) compliance, validation, and digital transformation. In her role at PSC Biotech, Chandler oversees technical operations and project delivery for leading life sciences companies implementing new technologies in the automation, robotics, and engineering spaces.
An alumnus of the University of Michigan where she studied Cell and Molecular Biology. Chandler combines this technical expertise with a commitment to innovation, making significant contributions to the advancement of digital transformation, compliance, and team development in the life sciences industry. Chandler has proudly served on the ISPE CaSA Emerging Leaders Committee since 2018 where she volunteered as a Chair of the committee from 2024 to 2026. Chandler was also given the honor of the ISPE CaSA Member of the Year Award in 2023.
Courtney Skunda Hall serves as the Vice President of Client Growth + Strategies at BE&K Building Group, a national construction services firm renowned for its expertise in design-build and construction management services. Based in the company's Research Triangle Park office in Morrisville, North Carolina, she leads national business development efforts with a particular focus on the Life Sciences Center of Excellence.
Before joining BE&K, Courtney held the position of Director of Projects + Prospects at the North Carolina Biotechnology Center (NCBiotech), where she played a pivotal role in advancing biotech initiatives across the state. She brings nearly 20 years of industry experience, combining strategic insight with a deep understanding of the life sciences and construction sectors. She earned her Bachelor of Arts in Political Science from James Madison University.
Courtney is also an active thought leader, contributing to BE&K’s Leadership Blog on topics such as food and beverage construction trends and life sciences development strategies.
Committee Chairs
Krisha Patel is the Co-founder of Assurea, a digital compliance consulting firm that provides IT/CSV and AI-powered services for fast-growing biotech companies. With a degree in Bioprocessing Science and over twelve years of experience in validation and quality assurance, Krisha has supported cell and gene therapy developers and pharmaceutical manufacturers in meeting global regulatory standards. She currently serves as the Co-Chair of the ISPE Advanced Therapy Medicinal Products (ATMPs) Community of Practice (CoP) and also as the Co-Chair of the Education Committee for the ISPE Carolina-South Atlantic (CASA) Chapter.
Eric Dean is a Senior Manager of Engineering Projects at Amgen, where he leads the delivery of large-scale capital projects that expand drug substance manufacturing capacity while improving cost certainty and schedule performance. With more than a decade of experience in biopharmaceutical manufacturing, he has played key roles on capital programs exceeding $1 billion, including critical wastewater treatment infrastructure and advanced manufacturing facilities.
Throughout his career, Eric has built a reputation for delivering high-impact projects by aligning cross-functional teams, managing risk, and maintaining strict control of cost and schedule. His background spans project controls, design management, estimating, contract negotiation, and construction execution, with a strong emphasis on sustainability and innovative facility delivery approaches.
In addition to his professional work, Eric is actively involved in industry and community leadership through ISPE‑CaSA and service with the Town of Holly Springs and is enthusiastic about developing future talent and advancing innovation across the life sciences and engineering disciplines.
Eric holds a Bachelor of Science in Biology from University of North Carolina Chapel Hill and is also a certified Project Management Professional (PMP).
Emerging Leaders Chair (Incumbent)
ECBuild
Julianne Bove is a talent and partnerships professional in the life sciences industry, currently with ECBuild, the construction management affiliate of EwingCole. With a background in talent acquisition and workforce strategy, she has built her career around connecting top talent with innovative organizations and fostering meaningful industry relationships. At ECBuild, she supports the firm’s mission of delivering complex projects across life sciences, providing end-to-end construction management services with a hands-on, client-focused approach.
In her current role, Julianne works closely with companies and professionals across the life sciences sector, supporting hiring initiatives, workforce planning, and community engagement. She is particularly passionate about creating pathways for students and early-career professionals to access opportunities within the industry, and she actively contributes to programs that promote education, inclusion, and professional development.
Beyond her professional work, Julianne is deeply engaged in the life sciences community through networking events, industry partnerships, and volunteer involvement. She values building authentic connections and believes that strong relationships are the foundation for both personal and organizational success.
Julianne brings an energetic, people-first approach to everything she does and is committed to supporting the continued growth and impact of the life sciences ecosystem in the region.
Emerging Leaders Co-Chair
Industrial Automated Systems, Inc.
Katie Friday is a Sales Engineer with Industrial Automated Systems, Inc. where she supports clients across the life sciences and industrial manufacturing industries through automation and systems integration solutions. In her role, Katie works closely with project teams and industry partners to help deliver innovative, client-focused solutions that support operational efficiency, process reliability, and long-term project success.
Katie is passionate about building meaningful relationships within the life sciences community and actively participates in industry networking events, professional organizations, and business development initiatives throughout the Southeast. She values collaboration, authentic connection, and creating partnerships that support both individual and organizational growth.
Through her involvement in industry events and community engagement opportunities, Katie is committed to supporting the continued advancement of the region’s growing life sciences ecosystem. She brings an energetic, relationship-driven approach to her work and enjoys connecting with professionals across engineering, manufacturing, and project delivery disciplines.
Aershen Muheyati is a distinguished engineering professional with deep expertise in pharmaceutical manufacturing, automation integration, and compliance strategy. He has played a critical role in the successful execution of over one billion dollars in capital biomanufacturing projects. At Sequence, he led CQV activities for large-scale greenfield facilities, including high-impact projects for Pfizer and Alnylam Pharmaceuticals. He was recognized with the “WFI Champion Award” for his leadership in WFI PQ execution, which are essential to GMP compliance and operational safety. His work has ensured regulatory readiness, production timelines, and committed to patients' earlier access to therapies.
To meet the growing demands of digital transformation in life sciences, Aershen earned a Master of Science in Information Science and later served as Lead Systems Engineer at Rovisys. There, he delivered integrated automation solutions for global pharmaceutical manufacturers, including Eli Lilly and Pfizer. His domain expertise spans process control, data systems, and regulatory compliance, with a strong foundation in PLC, SCADA, and MES, and industry standards including 21 CFR Part 11, GAMP 5, and ISA 88/95. He has authored CQV strategies and engineering templates that have been adopted across multiple facilities to streamline qualification, reduce risk, and enhance coordination across process, automation, and quality teams. Recognized for his technical judgment and regulatory insight, Aershen has been selected to review multiple draft guidance publications for the International Society for Pharmaceutical Engineering (ISPE), including those on continuous manufacturing, GxP process control systems, digital enablement, and oligonucleotide production. These contributions reflect his impact on shaping global best practices.
As an active member of ISPE CaSA, Aershen participates in technical panels, cross-functional working groups, and chapter initiatives that promote innovation and best practices in pharmaceutical engineering. His continued involvement supports the professional development of peers and contributes to the advancement of compliant and efficient pharmaceutical manufacturing systems.
IT and Social Media Co-Chair
ZETA
Grace Zadrzynski is a Business Development Manager at ZETA, supporting life sciences and pharmaceutical manufacturing projects across the Southeast. Her role involves building relationships across the biotech and pharma industry, connecting companies with solutions, and staying actively engaged within the life sciences community.
Outside of ZETA, she is very passionate about networking and industry engagement. Grace created and manages the RTP Life Sciences Networking & Events LinkedIn Group, which is approaching 1,000 members.
She also owns GoZad Marketing, a boutique marketing agency focused on supporting companies within the life sciences space. GoZad offers marketing services like LinkedIn content creation and page management, website design and refreshes, SEO optimization, and broader digital marketing strategies. Much of my work centers around helping companies strengthen their visibility, engagement, and connections within the industry.
Gina Thompson is the founder of GMT International Consulting and a seasoned leader in North Carolina’s life sciences sector. With over two decades of experience in organizational transformation, partner strategy, and workforce development, she has led high-performing teams and consulting practices at Körber Pharma and other industry leaders.
Gina is deeply committed to mentoring future professionals and strengthening the region’s biotech talent pipeline through her advisory role with Wake Tech and as Treasurer for the NC Life Science Apprenticeship Consortium and Co-Chair Membership for ISPE-CaSA. Her work continues to shape inclusive, resilient organizations across the life sciences ecosystem.
Ben Lyons is a business development leader at Wunderlich-Malec Engineering, where he focuses on life sciences and specialty chemicals. With more than 20 years of experience across analytical chemistry, bioprocess engineering, automation, and strategic growth, he brings a uniquely cross-functional perspective that bridges technical depth with business impact.
Ben has worked across the full value chain—from lab environments to large-scale manufacturing—and is known for connecting technical, operational, and commercial teams to advance complex initiatives. His background enables him to translate data, systems, and strategy into practical, people-centered solutions.
An active member of ISPE CaSA since 2022, Ben has served as IT/Media Committee Chair, where he has led digital communications and social media efforts to increase engagement and chapter visibility. He is passionate about strengthening member connections and leveraging technology to support sustainable growth across the chapter.
Outside of work, Ben lives in Raleigh, North Carolina, and enjoys spending time with his family and staying active outdoors.
Brian Stancel is a expert in Building Automation Systems (BAS), currently serving as the Business Development Manager at CMS Controls. With over 20 years of experience in process controls and Direct Digital Controls (DDC), he has played a pivotal role in optimizing building systems for pharmaceutical, laboratory, and mission-critical facilities.
Brian began his career focusing on electrical control system design and implementation within industrial settings. He joined CMS Controls, where he initially worked in installation and programming before advancing to project management. In 2009, he transitioned into business development and now leads the DDC Controls Division, overseeing strategic growth initiatives across the Southeast U.S.
Based in Raleigh, North Carolina, Brian is recognized for his commitment to integrating advanced automation solutions that enhance energy efficiency and operational reliability in complex environments.
Brian holds an Electronics, Electronics, Electrical, Controls AAS degree from Wake Technical Community College.
Ashley Chisholm brings nearly two decades of marketing and business development experience, with a strong focus on the life sciences, healthcare, and higher education sectors. She leads marketing strategy and operations at 35 North, a comprehensive construction services firm specializing in complex capital projects for life sciences organizations. The firm’s technical expertise spans the full project life cycle—including program and project management, construction, commissioning, and operational readiness.
Ashley is skilled at building brands, driving growth, and leading cross-functional teams to deliver measurable results. She plays a key role in shaping 35 North’s strategic growth initiatives, strengthening client relationships, and positioning the firm as a trusted partner for highly regulated, technical projects.
She is passionate about helping mission-driven organizations connect with their audiences and brings a collaborative, data-driven approach to campaign strategy and implementation, content development, and proposal execution. Ashley is excited to bring her skills to ISPE-CaSA to support its mission and enhance the chapter’s networking opportunities.
Phil Todaro is the Project Development Manager at RoviSys & RoviSys Building Technologies, where he leads Process & Building automation project development. With over a decade of experience, Phil specializes in providing integrated automation solutions for pharmaceutical, biotech, data center, industrial and mission-critical facilities.
Based in Raleigh, North Carolina, Phil is recognized for his commitment to advancing automation technologies that enhance operational efficiency and ensure compliance in complex and regulated environments. His expertise has been instrumental in shaping success at RoviSys in delivering cutting-edge solutions across diverse industries.
Outreach Co-Chair
Flad Architects
Alma Montemayor is an experienced business development leader at Flad Architects, where she focuses on building strategic relationships across the higher education, science, and healthcare sectors. Based in Raleigh, North Carolina, she is known for her ability to connect organizations, foster partnerships, and support the growth of complex projects.
Alma brings a strong track record of leadership within industry and professional organizations. She has served in multiple leadership roles with the International Society for Pharmaceutical Engineering (ISPE) Carolina-South Atlantic Chapter, including President and Past President, and remains actively engaged in initiatives that strengthen the life sciences and engineering communities.
Her broader industry involvement includes participation in organizations such as the North Carolina Economic Development Association and Triangle CREW, as well as past leadership with the Society for Marketing Professional Services. Through these roles, she has contributed to advancing collaboration, diversity, and professional development across the built environment and engineering fields.
Tech Show Chair
Freedom Industries
Kakki Collins is an Inside Sales & Marketing Manager at Freedom Industries Inc., where she leads integrated marketing efforts and supports business development through strategic campaigns and relationship-driven initiatives. She brings more than 15 years of experience in marketing, event planning, and program execution, with a strong track record of driving brand awareness and supporting sales team success.
Kakki is known for her ability to manage complex events and marketing programs—from logistics and vendor coordination to digital campaigns and trade shows—while collaborating across teams to deliver high-impact results. Her background spans roles in field marketing and marketing strategy across organizations including Proofpoint, Exyte, and PCI.
Tech Show Co-Chair
Commissioning Agents, Inc.
Jeff Wiltgen is an Area Client Manager at Commissioning Agents, Inc. in the Raleigh-Durham area, where he has led client-facing work since 2017. after several years as a Validation Engineer with the company. He brings a strong background in validation, quality, engineering, and project management with experience spanning pharmaceutical and manufacturing environments.
Jeff earned his degree in Chemical and Biomolecular Engineering from North Carolina State University. He has supported the ISPE CASA Chapter Committees and Board since 2020, serving in both the chair position for the Membership Committee as well as the Tech Show Committee.
Women in Pharma Chair
PM Group
Gina Stevenson has over 25 years of leadership experience in business development, marketing, sales, and operations across global engineering and pharma-focused firms. Known for leading cross-functional teams and fostering inclusive workplace cultures, she is committed to empowering women in the life sciences industry and driving initiatives that align with Women in Pharma’s mission.
Gina is the BD & Marketing Manager for PM Group, the Project Delivery Specialists that provide A&E Design services globally for the Life Sciences industry. Her role plays a pivotal part in launching and growing a new office, leading strategic planning, proposal development, and client engagement. She also organizes events, coaches colleagues, and champions internal culture—all experiences she’s excited to bring to Women in Pharma to help shape purposeful programming and create spaces where women feel seen, supported, and inspired to lead.
Women in Pharma Co-Chair
IPS
Mancy is a Persian chemical engineer who works in pharmaceutical manufacturing. She specializes in aseptic fill/finish operations and process engineering.
She works at IPS as a Subject Matter Expert (SME) in aseptic manufacturing. Her work includes manufacturing process and facility design, improving pharmaceutical production systems, solving process problems, supporting compliance, and helping manufacturing systems meet ever changing safety and regulatory standards. She focuses on making processes more reliable, efficient, robust and safe for patients.
Mancy earned her Master of Engineering from University of Illinois Chicago and her Bachelor of Science in Chemical Engineering from Sharif University of Technology.
Beyond engineering, she cares about doing meaningful work that improves human health, happiness, and performance.
At Large
Aaron Rice, MBA, PMP, serves as the Senior Director of Engineering and Facilities at Beam Therapeutics, a biotechnology company pioneering precision genetic medicines through base editing. Based in North Carolina, Rice leads the design, construction, and operational strategy for Beam’s advanced manufacturing infrastructure, including the company’s multi-modality Cell and Gene Therapy facility in Research Triangle Park (RTP).
Under Rice’s leadership, the RTP facility was recognized as a finalist in the Innovation category of the 2024 ISPE Facility of the Year Awards (FOYA), highlighting its cutting-edge capabilities and contribution to the advancement of cell and gene therapy manufacturing.
Prior to joining Beam, Rice held senior engineering roles at Jacobs and bioMérieux, where he managed complex capital projects and facility operations in the life sciences sector.
Rice holds a Bachelor of Science in Mechanical Engineering and a Master of Business Administration from North Carolina State University and is a certified Project Management Professional (PMP).
Andrew Campbell, PE, LEED AP, serves as Associate Director of Corporate Real Estate at United Therapeutics Corporation, a biotechnology company renowned for its commitment to sustainability and innovation. With over 15 years of experience in construction and development, Campbell specializes in sustainable design and construction within the life sciences sector.
At United Therapeutics, Campbell has led several groundbreaking projects aimed at achieving net-zero energy goals. Notably, he spearheaded the development of the “Phase Five” net-zero logistics center in Research Triangle Park, North Carolina, which is powered in part by a microgrid system utilizing Tesla Megapacks. This facility supports the distribution of the company’s Tyvaso DPI® therapy and exemplifies the integration of sustainability with pharmaceutical manufacturing.
Campbell has also been instrumental in the development of a 196,000-square-foot pharmaceutical manufacturing facility constructed with a hybrid mass timber and steel structure. This facility aims to achieve zero embodied carbon, setting a new standard for sustainable construction in the biotech industry.
He holds both BS and MS degrees in civil engineering and construction management from Virginia Tech.
Novo Nordisk
Becca Ford is a Vice President of Project Delivery at Novo Nordisk, where she leads large-scale capital delivery initiatives supporting the development of innovative manufacturing facilities that serve patients worldwide. She brings more than 20 years of experience delivering complex, multibillion-dollar projects, with a focus on building high-performing teams and advancing scalable, efficient facility design.
Becca is known for her leadership in transforming capital delivery through innovative, repeatable models that prioritize quality, sustainability, and speed to meet growing global demand. Her work centers on aligning technical operations, construction, and cross-functional teams to deliver best-in-class facilities that enable the next generation of pharmaceutical manufacturing.
She holds a Master’s degree in Chemical Engineering and an MBA from the Massachusetts Institute of Technology through the Leaders for Global Operations program. https://www.linkedin.com/in/becca-ford-capital-delivery
In addition to her professional role, Becca is actively engaged in industry and community leadership. She serves on the board of ISPE-CaSA and LifeSmart Youth, supporting initiatives that strengthen the life sciences community and empower future generations.
Deb Hittel is the Head of Capital Projects Delivery at CSL Seqirus, a global leader in influenza vaccine development and manufacturing. Based in Holly Springs, North Carolina, she plays a pivotal role in ensuring the operational reliability and compliance of one of the region’s most advanced biomanufacturing facilities.
Beyond her technical leadership at CSL Seqirus, Deb is a prominent advocate for workforce development in the life sciences sector. She serves as Chair of the North Carolina Life Sciences Apprenticeship Consortium (NCLSAC), a collaborative initiative comprising over a dozen major biopharmaceutical employers—including Amgen, Biogen, Merck, and Pfizer. Under her guidance, the consortium has expanded access to registered apprenticeships and BioWork training programs, providing career pathways for students, veterans, and career changers across the state.
Deb is also actively involved in community engagement. She has represented CSL Seqirus at events such as the NC Biotech Manufacturers Forum, Accelerate NC Coalition Impact Summit, and Wake Tech Community College Career Fair where she highlighted the importance of apprenticeships in building a skilled and diverse life sciences workforce.
Prior to her current position, Deb held several key roles at Merck, including Associate Director of Plant Engineering, Capital Projects, and Reliability, Utilities and Calibrations Manager, and Reliability Engineer. Before joining Merck, she worked as a CQV Lead and Project Engineer at Jacobs Engineering.
Deb’s leadership reflects a commitment to both operational excellence and inclusive talent development, making her a key contributor to North Carolina’s growing biomanufacturing ecosystem.
She holds a bachelor’s degree from Indiana University and has completed Post Graduate Coursework at Indiana University’s Kelley School of Business.
Jacob A. Paradiso, PMP, is a Senior Manager of Project Engineering at Thermo Fisher Scientific, a global leader in pharmaceutical services, including contract development and manufacturing (CDMO). Based in Greenville, North Carolina, he leads strategic capital planning and execution that expands manufacturing capacity in support of Thermo Fisher Scientific's mission to enable its customers to make the world healthier, cleaner, and safer while accelerating the delivery of innovative therapies to patients.
Mr. Paradiso has held engineering and leadership positions with Thermo Fisher Scientific, Alcami Corporation, West Pharmaceutical Services, and Georgia-Pacific, where he built expertise in capital project delivery, facilities engineering, manufacturing operations, and strategic capital investment. Recognized for building high-performing teams and fostering collaboration across internal multi-disciplinary groups, external partners, and clients, Mr. Paradiso has a proven track record of delivering complex capital programs safely, efficiently, and in compliance with regulatory requirements. His leadership has consistently expanded manufacturing capacity, improved operational performance, and supported long-term business growth.
Mr. Paradiso earned a Bachelor of Science in Mechanical Engineering from North Carolina State University. He is a Project Management Professional (PMP), a licensed North Carolina Electrician, and is pursuing Professional Engineer (PE) licensure. He is passionate about developing high-performing engineering organizations and delivering strategic capital investments that strengthen pharmaceutical manufacturing capabilities and improve patient access to life-changing therapies.
Jennifer Mitchell is an engineering leader with over 25 years of experience in the biotechnology and pharmaceutical sectors. She currently serves as the Head of Small Scale and Disposable Manufacturing at Biogen, a role she has held since October 2023 . In this capacity, she oversees the manufacturing processes in stainless steel and single-use technologies providing flexibility and efficiency in biologics production.
Prior to her current position, Jennifer held several key roles at Biogen, including Interim Head of Engineering & Facilities, Director of Process Engineering, and Senior Manager of Validation Engineering. Her tenure at Biogen began in the early 2000’s, and over the years, she has played a pivotal role in advancing the company's manufacturing capabilities. Before joining Biogen, she worked as a Manufacturing Engineer at Corning Incorporated.
Jennifer’s has a Bachelor of Applied Science in Chemical Engineering from The University of Alabama in Huntsville. She has also pursued executive education at Dartmouth College's Tuck School of Business and is currently starting her MBA with UNCW equipping her with a strong foundation in both technical and managerial aspects of the industry.
Jennifer Popovich began her career at Catalytica – Greenville, NC site in the Active Pharmaceutical Ingredients division (API) in 1998. While working in the API division, she held roles in both Validation and Quality. Performed various types of validation relating to the API manufacturing such as process, cleaning, and equipment/facilities. In the Quality division, she was responsible for lot disposition, investigations, and compliance. In 2004; Jennifer transitioned to Oral Solid Dose (OSD) Validation with DSM Pharmaceuticals, Inc. This opportunity with the Orals and Topicals Manufacturing business unit expanded her validation and quality knowledge further by learning about the various dosage forms (tablets/capsules, liquids, ointments, and creams), the equipment used for each unit of operation, associated critical process parameters, and validation requirements for Oral and Topical products.
Jennifer Popovich then continued her career in validation at Sandoz – Wilson, NC (2010) where she acquired experience in project management, technical services, and validation program development. Popovich returned to solid dose manufacturing validation at Patheon – Greenville, NC in December 2012 as Manager of the OSD Validation department. Here she developed the existing staff and created a validation team supporting process, packaging, cleaning, equipment, and facilities validation and development activities for OSD and Animal Health Products.
In February of 2018, Popovich became the CPV (Continued Process Verification) Program Manager. In this role, she has worked with Patheon (Thermo Fisher) corporate and the Patheon global network to create the overall CPV corporate guideline and program as a key member of the CPV Core Team. She is the Greenville, NC site lead for CPV for both the OSD and Sterile business units, as well as remains an active member of the CPV core team providing governance and support to the Global Network for CPV.
In January of 2019, Jennifer accepted the position of Director of Validation at Mayne Pharma. She currently leads a team of 12 employees who perform all validation activities for the site. She developed the site cleaning program, cleaning validation approach, and updated the process validation program to align with the FDA’s 2011 Process Validation Guidance. Now Catalent Pharma Solutions, she continues to work at the Greenville, NC site and leads the validation and other teams to develop and improve site processes and systems.
Jennifer holds a Bachelor of Science in Biology degree from East Carolina University.
Lisa Burleson is the Facilities and Engineering director for the new Drug Substance manufacturing site at Amgen in North Carolina. She has over 20 years of biotechnology industry experience with extensive knowledge in Utility and Drug Substance Design.
Lisa is a ChE from Iowa State and began her Amgen career in 2000 in Colorado. She has held various roles in Facilities and Engineering, Validation, Site and Global Engineering, and Capital Projects. Her experience ranges from both the owner and contractor perspectives on project and process design. Her leadership has been instrumental in advancing Amgen’s strategic initiatives in the Research Triangle region. Her commitment to operational excellence and industry collaboration underscores her status as a respected leader in pharmaceutical engineering.
As a mom to three, Lisa enjoys reading, physical fitness, and trying new things.
Lisa Evans is a seasoned professional engineering and quality assurance leader, currently serving as Senior Manager of Engineering (EMU) Compliance at Pfizer’s Sanford, North Carolina facility. With a career spanning over three decades, she brings a wealth of experience in process engineering, quality systems, manufacturing, and validation.
In her current role, Lisa oversees EMU compliance initiatives that support Pfizer’s advanced manufacturing operations, including vaccine and monoclonal antibody production . Her leadership ensures adherence to stringent regulatory and finance standards and fosters a culture of continuous improvement and operational excellence.
Lisa is recognized for her collaborative approach and cross-functional expertise, which has been instrumental in driving process improvements and maintaining high-quality standards within the organization. Her commitment to excellence and her ability to navigate complex regulatory environments make her a valuable asset to Pfizer’s engineering and compliance teams.
Lisa holds two Bachelor of Science degrees, in Chemistry and Chemical Engineering, as well as a Master of Science in Analytical Chemistry, both from North Carolina State University and a Master of Arts in Ministry to Women from Southeastern Theological Seminary.
Marc Bonner revitalized Biogenic Technologies LLC consulting after 4 years as the Executive Director of Manufacturing Science and Technology (MS&T) at BioCryst Pharmaceuticals, Inc., based in Raleigh, North Carolina. With a career spanning over three decades in the healthcare, pharmaceutical, and biotechnology sectors, Marc has held pivotal roles that have significantly influenced the industry.
Marc has amassed extensive experience in various capacities from biologics to small molecules and from working at large companies to starting one. He held leadership roles at Mayne Pharma, Sandoz and Mallinckrodt. He has served as President at Biogenic Technologies, and Senior Consultant with Sequence and other firms. His diverse roles have equipped him with a comprehensive understanding of the industry's intricacies.
Marc's commitment to knowledge sharing is evident in his participation in industry conferences. Notably, he regularly presents on topics such as nitrosamines and device selection for biologics development at the Annual ECU Spring Pharma Conference, highlighting his expertise in addressing contemporary challenges in pharmaceutical manufacturing.
He holds a Bachelor of Science in Chemical Engineering from New Mexico State University.
Melody Scott, MS, MBA, serves as Director of Supply Chain at Amgen Inc., where she is based in North Carolina. With a strong foundation in pharmaceutical operations, supply chain, and logistics, she plays a critical role in ensuring the seamless and timely delivery of Amgen’s life-saving therapies to patients around the world.
In addition to her leadership at Amgen, Melody is an active advocate for professional development and inclusion within the pharmaceutical industry. She serves as the Women in Pharma® Liaison on the International Program Committee for the International Society for Pharmaceutical Engineering (ISPE), where she champions initiatives centered on diversity, equity, and inclusion. She has chaired the Women in Pharma Committee for the ISPE Carolina–South Atlantic Chapter, supporting mentorship, networking, and career advancement for women across the industry.
Melody holds a Bachelor of Science in Chemical Engineering from Virginia Tech, a Master of Science in Chemical Engineering from North Carolina State University, and an MBA from Duke University. Her dedication to excellence and her impact in both corporate and professional arenas reflect her unwavering commitment to advancing the pharmaceutical field and empowering its future leaders.
Michael J. Zivitz is the Vice President of Global Engineering Solutions at Merck, bringing over three decades of experience in pharmaceutical engineering and capital project leadership. Based in Raleigh, North Carolina, he leads Merck’s global capital project design and delivery efforts, with a focus on human health vaccines and biologics.
Zivitz began his career at Schering-Plough before joining Merck, where he has held progressively senior roles, including Director, Executive Director, and Associate Vice President. He has overseen major engineering initiatives across the U.S., Europe, and Asia-Pacific, contributing to the design and execution of sterile, vaccine, and biologics manufacturing facilities
A strong advocate for innovation in biomanufacturing, Zivitz has co-authored industry publications on modular facility design and next-generation manufacturing strategies.
He holds dual bachelor's degrees in Chemical Engineering and Biology from Bucknell University and a master's degree in Chemical Engineering from Rutgers University.
