| Patrick Archer President/ CTO BWT Patrick Archer has worked on clean utilities in the pharmaceutical industry for the last 25 years. His journey with process engineering for clean utility systems started in 1997 shortly after graduating from college he began his career with a water treatment company in Ireland which later became BWT Pharma & Biotech. As the lead engineer he designed numerous Purified Water and Water for Injection projects that incorporated ozone technology in Ireland, Europe and Singapore. In 2014 his career transitioned to the United States where he currently leads operations for BWT Pharma & Biotech in North America. | |
| Jes Averhart (Moderator) CEO of Jes & Co and Creator of Reinvention Road Trip Jes & Co Over the last two decades, Jes Averhart has worked with a portfolio of Fortune 500 companies, public sector organizations and high-performing individuals interested in increased personal growth and greater professional impact. Jes is a 4th generation entrepreneur, creator of Reinvention Road Trip® and 3x award-winning author. She advises high-performing individuals and corporate teams as a leadership development and master certified life coach. With over 20 years of cross-industry corporate engagement, Jes has worked with many Research Triangle Park companies including Google for Startups, Fidelity Labs, Wells Fargo, Coastal Credit Union, Blue Cross Blue Shield and Lincoln Financial to name a few. In 2015, Jes co-founded Black Wall Street Homecoming, a nonprofit aimed at closing the funding gap for Black and Brown tech founders. Earlier in her career, she provided production management services for the likes of the Cincinnati Bengals & Cleveland Browns (NFL), Cleveland Cavaliers (NBA), the Procter & Gamble Company and Pepsi Cola North America. | |
| Travis Floyd Metrology Specialist Novo Nordisk Travis Floyd has had a successful career in the pharmaceutical industry, starting as a Metrology Technician in a greenfield API facility in 2018 and becoming a Metrology Specialist in 2021. Prior to joining the pharmaceutical industry, he served a 4-year enlistment in the US Navy as a Machinist Mate. In his current role, he has played a crucial role in the implementation and management of the metrology program, and has also been responsible for writing SOPs, deviations, and calibration methods. He has consistently demonstrated his expertise in the field of metrology and calibrations and has been instrumental in helping other sites adopt effective procedures. | |
| Robert Holland Senior Engineering Specialist Novo Nordisk Robert Holland has been working in the pharmaceutical industry for 13 years. Prior to that, he served in the US Navy for 9 years as a nuclear propulsion plant supervisor, and nuclear power instructor. His pharmaceutical industry experience began in 2010 with a commissioning and validation company. There, he gained experience with working on numerous projects and learning about lots of different types of systems and programs within the pharmaceutical industry. He took a position as a process engineer with a local pharmaceutical company in 2016 to be the work package owner for clean utility systems on a large green field project. He was responsible for the design, start-up, validation, and transition from project to routine operation of the clean utility systems on this greenfield project. He is currently serving as the senior engineering specialist for the facilities department and working with sites worldwide within his company to implement Ozone Sanitization. | |
| Rodney Lam (Moderator) Director, Head of Engineering Seqirus As Head of Engineering at CSL Seqirus, Rodney serves as a member of the Holly Springs Site Leadership team, while also partnering with engineering leaders in Australia and the UK on knowledge sharing and best practices. Previously at CSL Seqirus, Rodney directed the launch of a new packaging technology division as a part of the Global Manufacturing Sciences and Technology (MS&T) team, and directed drug product manufacturing operations including the expansion of the site Fill and Finish capacity. Earlier roles include automation management for Novartis Vaccines and Merck. Rodney earned his Master’s in Systems Engineering at Penn State University and completed his Bachelor’s in Computer Science from James Madison University. His organizational memberships include the International Council on Systems Engineering (INCOSE), the International Society of Pharmaceutical Engineering (ISPE), and the International Society on Automation (ISA). | |
| Scott Menut Utilities Manager, Maintenance Engineering Seqirus -Graduated from North Carolina State University, BS Chemical Engineering -Began career working for Eastman Chemical Company (Kingsport, TN) within Process Engineering supporting Specialty Plastics -Ten years of experience, working at CSL Seqirus (formerly Novartis) HSP site -5 years of experience within Process Engineering supporting Clean Utilities -5 years of experience managing Utility and HVAC teams | |
| Scott Mitchell Azzur Group Scott Mitchell oversees Azzur's national Talent Acquisition Team and partners with organizational leadership to enhance the development of a talent pipeline which is essential to Azzur's growth. Scott brings nearly two decades of unique experience to Azzur Group, specializing in pharmaceutical and life sciences, manufacturing and distribution, and professional services. He holds a Bachelor of Science in Marketing from Central Connecticut State University and is currently completing his Human Resource Management certification from Villanova University. | |
| Thomas Nash Automation Manager Seqirus Thomas has worked in automation industry for over 25 years with covering a wide range of industries from Biotech/ Pharma to Nuclear and Coffee. Most of his experience has been in pharmaceutical industry, where he started as a consultant to Bristol Myers Squibb research division and worked his way to corporate Automation Manager of Schering-Plough. Currently at Seqirus, his most recent project was lead automation engineer for the sites ($150M) Fill Finish Expansion. Now, in his new role he provides technical automation leadership and project management to the Fill-Finish segment for the purposes of commercial readiness, technical transfers, maintenance/ support, process improvements and new projects/ initiatives. | |
| Arleen Paulino Senior Vice President Manufacturing Amgen Ms. Arleen Paulino is senior vice president, Manufacturing. In this role, Ms. Paulino leads Amgen’s commercial manufacturing organization where she is responsible for all internal and external manufacturing operations and strategic supplier relationships to deliver reliable supply for patients across the globe. Prior to this role, Ms. Paulino served as vice president, Site Operations at Amgen Singapore Manufacturing, where she led the team to the successful licensure of Amgen’s first Next-Generation Biomanufacturing plant. Ms. Paulino joined Amgen in 2002 and over the years has held various positions with increasing responsibility in Process Engineering and Process Development. She was also the head of Clinical Operations and Development Supply Chain, where she was responsible for the end-to-end supply chain for the manufacture and delivery of clinical product to support Amgen’s global clinical trials. She began her career in Operations at Genentech and later joined Immunex, where she held a variety of roles overseeing development and scale-up operations, contract manufacturing, technology transfer, and plant management. Ms. Paulino is a champion for change and innovation, an avid supporter in advancing science causes, and an advocate for empowering women in the STEM field. Her passion is to create cultures where diversity brings strength, inclusion is celebrated, and everyone feels a sense of belonging. She contributes actively to the community and sits on various committees including serving on the Board of Directors of Senior Concerns. Ms. Paulino holds a Bachelor of Science degree in Biochemistry from Marquette University. | |
| Stephenie Robertson Vice President, Global Quality Systems and Compliance Fujifilm Diosynth Biotechnologies in RTP 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, where her graduate research involved mathematical modeling of human platelet aggregation. Stephenie 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 held the position of Vice President of Operations, responsible for Engineering, Supply Chain and Safety, before moving into her current role as Vice President, Global Quality Systems and Compliance. | |
| 0 | Melanie Rondot Principal Engineer- Packaging and Visual Inspection Process Engineering Seqirus Graduated from Purdue University, BS Chemical Engineering Began career working for an engineering firm as process/project engineer primarily supporting form/fill/pack and facility/utility projects for a “Big Pharma” client manufacturing sterile injectable products Transitioned to consumer health industry as process engineer for form/fill/pack of cough syrups and nasal sprays Moved to NC in early 2012, working at CSL Seqirus (formerly Novartis) HSP site for 11 years as process engineer supporting FF of influenza vaccines with primary focus on automated inspection, packaging, and serialization |
| Tracy Schorner Executive Director/ Plant Manager Amgen North Carolina Tracy Schorner is currently the Plant Manager of the new Drug Substance Facility under construction in Holly Springs, North Carolina. This plant is being built to launch Amgen’s innovative new “FleX Batch” process platform and aspires to be the most digitally advanced and sustainable plant in their network. Tracy began her career at Amgen in Rhode Island in 2003 as a Manufacturing Operator and held various roles across Drug Substance Manufacturing and Engineering in Rhode Island and California as she grew her skills and responsibilities. In her current role she is responsible for ensuring operational readiness of the plant for production in 2025 which includes hiring a highly skilled team of dedicated and diverse talent. Tracy holds a B.S. in Chemical Engineering from Lafayette College. She is a subject matter expert in new product introduction, technology transfer and operational excellence. She is passionate about continuous improvement and mentoring. | |
| Christine E. Vannais Chief Operating Officer FUJIFILM Diosynth Biotechnologies Christine joined FUJIFILM Diosynth Biotechnologies family in 2012 and she has led the North Carolina Manufacturing Operations team since 2014 as part of the Site Leadership Team. In this role she has been responsible for the site’s 24/7 manufacturing operations, which include cGMP production in both microbial and mammalian systems, for clinical and commercial drug substance delivery. In this role, Mrs. Vannais is responsible for the site quality compliance and delivery, with the support of the Quality Organization. Mrs. Vannais brings over twenty years of experience working in a variety of industries including contract biopharmaceutical development and manufacturing, USDA biological vaccine manufacturing and research, FDA and EU small molecule manufacturing, primary and secondary packaging operations, API potent compound manufacturing, Department of Defense sites, among others. She has a bachelor’s degree in Environmental Health from Colorado State University. | |
| David Wiggs Principal Engineer, Aseptic Filling Process Engineering Seqirus David Wiggs currently works at CSL Seqirus Vaccine Production Facility Holly Springs, NC as a Principal Process Engineer (2015-Current). He worked lead the installation of 3 filling lines during his time here while supporting the existing filling line with improvements and process engineering support. He worked with Eisai as a Sr. Process Engineer (2008-2015) to lead the commercial expansion to include Filling, Formulation, Packaging and Support. This facility was to support a new Breast Cancer drug, HALAVEN®. He worked as a Sr. Project Engineer with Bayer/Talecris (2005-2008) Leading Filling, Lyophilization, Pasteurization and Packaging projects. This included new installations as well as upgrades. He worked as a Process Engineer with O’Neal Engineering (1999-2005). During his time there he worked with multiple clients; Medimmune, GSK, Novo Nordisk, Bayer, Andrx Pharmaceuticals, Yamanouchi Pharma, Lightspec, and BASF among others. He Graduated from NC State University 1999 with a BS in Chemical Engineering, concentration in Bioscience. He worked in QC microbiology department in Pharmacia and Upjohn (1989-1998). He supported the QC department through validation and approval of the new QC facility as well as monitoring and testing for the manufacturing facility. | |
| Chris Zaino Process Engineer III, Bulk Downstream and Support Process Engineering Seqirus Chris Zaino graduated with a Chemical Engineering Degree from NC State University in 2014. He started his career as a Process Engineer in the paper industry earning his six sigma green belt. Later on he became a shift supervisor with responsibility for the entire Mill. Chris then moved into the Biotechnology industry as a Process Engineer with Seqirus. He has now been at Seqirus for four years working in the Bulk Drug Substance area primarily in the Downstream and Support areas. | |
