BTEC recognizes the industry professionals and subject matter experts (SMEs) who contribute to its teaching mission with BTEC Fellow appointments each academic year. With these BTEC Fellow appointments, the university’s College of Engineering formally recognizes the significant role that these industry professionals play in contributing to the high quality industry-focused training and education programs at BTEC. To be considered for an appointment as a BTEC Fellow, candidates must be nationally recognized SMEs and currently participating in BTEC teaching (contributing to a NC State undergraduate or graduate course, a BTEC professional development course, or a course offered as part of a BTEC training program). Fellow appointments are for a period of two years. Reappointment is by request of the Fellow.
Brief profiles are provided for the current BTEC Fellows:
- Ray Anover
- Lucia Clontz, M.S., D. H.Sc.
- Marcello Fidaleo, Ph.D.
- Paula Keith, Ph.D.
- Frederick W. Porter, Ph.D.
- Dale Pulczinski
- Saly Romero-Torres, Ph.D.
- Juan Torres, Ph.D.
Ray Anover currently manages the biologics development and manufacturing technical operations for Veloxis Pharmaceuticals at the company’s global headquarters in Cary, N.C. Veloxis is a wholly-owned subsidiary of Asahi Kasei Pharma, which is based in Tokyo, Japan.
Mr. Anover has more than 20 years of experience in the biotech industry. Prior to joining Veloxis Pharmaceuticals in 2020, he managed the biologics development and manufacturing operations for Chiesi Pharmaceuticals at the company’s U.S. headquarters in Cary, N.C., for six years. Previously, he coordinated student programs at BTEC for four years. Additional experience includes work at VaxGen in San Francisco managing the international technology transfer from client Bristol Myers Squibb in Syracuse, N.Y., to the contract manufacturing organization (CMO) Celltrion, located near Seoul, South Korea. He also worked in facility startup and tech transfer for Wyeth Vaccines in Sanford, N.C., and was employed by Tanox Biosystems, which eventually became part of Genentech.
Mr. Anover holds a Bachelor of Science degree in biology, with a minor in chemistry and a pre-medicine concentration, from Baylor University in Waco, Texas.
Lucia Clontz, MS, D. H.Sc.
Lucia Clontz, D. H.Sc., M.S., is the former head of Site Quality Head at Xellia Pharmaceuticals in Raleigh. She has more than 26 years of industry experience in quality, pharmaceutical microbiology, laboratory management, operational excellence initiatives, and training.
She is a published author, speaker and workshop leader at both national and international conferences, and in 2004, she received the Parenteral Drug Association's Distinguished Editor/Author award. A co-founder of the Biofilm Networking Group, Dr. Clontz is also a member of the United States Pharmacopeia (USP) Pharmaceutical Waters Expert Panel (2010-2015) and co-developer of the Contamination Control by Design© (CCbD) concept.
Dr. Clontz has Bachelor of Science degrees in chemistry, with a minor in chemical engineering, and in marine sciences. She also holds a master's degree in microbial biotechnology and a doctorate in health sciences.
Marcello Fidaleo, Ph.D.
Dr. Marcello Fidaleo is an associate professor in the Department for Innovation in Biological, Agro-Food and Forest Systems at the University of Tuscia, Italy, where he teaches unit operations and design and analysis of experiments for the food industry.
His research interests include modeling of membrane processes and enzymatic and microbial processes in the area of food biotechnology. He has carried out research as a visiting scholar at the Biotechnology Institute of the University of Minnesota and as a Fulbright scholar at NC State’s Department of Chemical and Biomolecular Engineering.
Dr. Fidaleo holds a master's degree in chemical engineering from the Sapienza University of Rome and a doctorate in food biotechnology from the University of Tuscia.
Paula Keith, Ph.D.
Leveraging a 30-year track record of bacterial and viral vaccine development, Dr. Paula Keith heads an independent consulting business, BioLogic Solutions, LLC, which she founded after leaving Novartis Vaccines. The firm provide services in several key areas of clinical trial materials (CTM) manufacture and program management, including bioprocess development; analytical methods development; scale up and technology transfer; GMP production and CTM release testing; selection and oversight of third-party contract manufacturing organizations (CMO) and contract research organizations (CRO); and strategic planning (scientific due diligence, intellectual property review, portfolio and competitor analysis, timing and regulatory).
During her tenure at Novartis Vaccines in North Carolina, she led the R&D team that developed the present influenza cell culture process for both seasonal and pandemic flu vaccines (now in commercial production) and also directed the early development pipeline of viral programs (RSV and HIV protein subunit vaccines) into GMP production, enabling the start of ongoing Phase I trials. Novartis Vaccines’ North Carolina pilot plant is also an Advanced Development and Manufacturing (ADM) facility, where Dr. Keith assumed strategic planning responsibility for medical countermeasures (MCM) government contracts, including recent Ebola monoclonal task orders.
Dr. Keith is a technical manager with more than 30 years of experience in development of new biologics in both large pharmaceutical companies and small biotech organizations. Her scientific expertise is in bioprocess/product development, analytical methods development, and GMP production of Phase I, II and III clinical trial materials. She has led scientific teams that developed GMP manufacturing processes for more than 20 antigens, made GMP supplies and moved these investigational new drug (IND) materials into Phase I studies; of these, a total of 13 advanced through Phase II and III to FDA licensure. Her track record of accomplishments includes expertise with microbial manufacturing platforms (glycoconjugates, recombinant subunits, virus like particles, DNA), mammalian expression systems (CHO, Vero, MDCK-derived glycoprotein subunits, live virus vaccines, and viral vectors), and synthetic biology (RNA, adjuvants). In addition, she has extensive experience in running global tech transfer teams, linking the R&D scientific knowledge of the process/product to the plans for GMP facility/equipment design, staffing, clinical testing, and regulatory strategy. Dr. Keith also has significant alliance management experience, including technology evaluations, licensing of new product opportunities, and management of outside contractors (CMOs,CROs) and research collaborations (e.g., NIH , Gates Foundation, HHS).
Frederick W. Porter, Ph.D.
Frederick W. Porter, Ph.D., is an 18-year veteran of the biopharmaceutical and vaccines industry. In his current role as Senior Vice President of Technical Development and Manufacturing Gene Therapy at BridgeBio Pharma, he leads the development and industrialization of novel gene therapy treatments for rare diseases. Throughout his career, Dr. Porter has held key scientific and management positions in academia and the biopharmaceutical industry including positions at Duke University, GlaxoSmithKline, and Novartis Vaccines. His R&D expertise includes production and characterization of vaccines, gene therapy vectors, nucleic acid and recombinant protein therapeutics. Some of his key contributions to the field include the development of cell culture-based influenza, RSV and HIV vaccines, and industrialization of mRNA therapeutics. Dr. Porter holds a doctorate in biochemistry from The University of Wisconsin-Madison, a Master of Science in microbiology from Seton Hall University, and a Bachelor of Science in biochemistry from Rutgers University.
Mr. Dale Pulczinski is currently Director of Aseptic Production for Novo Nordisk Pharmaceuticals in Clayton, N.C. Serving in various roles and departments over 16 years, his expertise is in the areas of aseptic manufacturing, process engineering and operations excellence. He has spent 1½ years living in Denmark, where he was responsible for driving productivity improvements across multiple international manufacturing sites, to include locations in Brazil, France, Denmark and China.
Prior to joining Novo Nordisk, he completed naval training and qualification as a nuclear power officer, going on to serve on submarines in both the San Diego and Seattle areas. In addition, he spent two years as an assistant professor of naval science at George Washington University, specializing in naval engineering.
He holds a Bachelor of Science degree in mechanical engineering from Arizona State University and a master’s degree in engineering management from George Washington University in Washington, D.C.
Saly Romero-Torres, Ph.D.
Dr. Romero-Torres is a senior manager of Process Data Analytics at Biogen RTP. She has over 15 years of experience in the field of Process Analytical Technologies (PAT) and advanced manufacturing of biopharmaceuticals with a focus in the use of advanced sensors, statistical process control, multivariate data analytics and operational excellence. She obtained a doctorate in pharmaceutical PAT from Purdue University in 2006 and has worked for companies such as Schering Plough, Wyeth, and Pfizer. In 2014, Dr. Romero-Torres founded Bio-Hyperplane LLC, a data analytics and consultation company. At Bio-Hyperplane LLC, Romero-Torres worked with a broad portfolio of industries including biopharma, automation software (semiconductors), data analytics software and instruments. Her personal mission is advancing pharmaceutical manufacturing processes to enhance plant operations and, more importantly, improving patients’ access to critical therapies.
Juan Torres, Ph.D.
Dr. Juan Torres is Senior Vice-President of Global Quality and Chief Quality Officer for Biogen. In this capacity, he has worldwide responsibility over Quality Systems for Biogen and cGMP oversight of all Biogen production sites. He has been with Biogen for 15 years and has almost 30 years of industrial experience in the area of biological manufacturing. Prior to joining Biogen, Dr. Torres was Director of the Process Sciences department at Centocor, Inc.; before that, he held positions of increasing responsibility over an eight-year period for Bayer Biological Products in Analytical Development, Quality Control, and Quality Assurance. He started his career working in R&D for Akzo Nobel.
Dr. Torres has served as a member of the Advisory Board of the NC State Poole College of Management and as a member of the Board of Directors of the Raleigh Chamber of Commerce. He also is the founder of Ingenuitas, a non-profit focused on STEM education and solving health problems in the developing world. In addition, he is a founding member and served as board president for Hands of Compassion, a non-profit organization providing primary medical services for impoverished communities in South America and Africa. Dr. Torres is a 2014 recipient of Triangle Business Journal Leader in Diversity award.
Dr. Torres holds a doctorate in biochemistry and toxicology from North Carolina State University and has postdoctoral experience in the univeresity's Department of Chemical and Biomolecular Engineering, where he studied novel techniques for large-scale protein purification. He also holds a Master's of Science degree in organic chemistry.