BTEC Teaching Fellows
BTEC recognizes the industry professionals and subject matter experts (SMEs) who contribute to its teaching mission with BTEC Teaching Fellow appointments each academic year. With these Teaching 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.
Current BTEC Fellows are listed below.
Ray Anover currently manages the biologics development and manufacturing operations for Chiesi Pharmaceuticals at the company’s U.S. headquarters in Cary, N.C. A multinational company, the firm’s global headquarters are located in Italy.
Mr. Anover has more than 20 years of experience in the biotech industry. Prior to joining Chiesi USA in 2014, he coordinated student programs at BTEC for four years. Previous 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., works as 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 assistant 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.
Baley Reeves, Ph.D.
Dr. Baley Reeves served as a Senior Scientist at BTEC from 2010–2016. As a Senior Scientist, she taught courses in downstream bioprocessing for both NC State students (BEC 436/536, Introduction to Downstream Process Development, and BEC 485/585, cGMP Downstream Operations) and industry professionals. She also contributed to process development projects in conjunction with industry partners and co-authored a number of articles on the design of BTEC's courses and curriculum. Since 2016, Dr. Reeves has taught at BTEC on a part-time basis, with a focus on delivering downstream bioprocessing topics in custom short courses.
Dr. Reeves holds a doctorate in chemical engineering from Princeton University and a Bachelor of Science in chemical engineering, with a bioengineering specialization, from the University of California, Los Angeles. As a graduate student she was a National Science Foundation graduate fellow and focused her dissertation on the development of novel, economical methods for protein purification. The results from these studies were published in journals including Trends in Biotechnology, Protein Science, Microbial Cell Factories, and Protein Expression and Purification.
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.
Abhinav A. Shukla, Ph.D.
Dr. Abhinav Shukla, Vice President of Process Development and Manufacturing at KBI Biopharma, has more than 15 years of experience in process development in biopharmaceuticals, from early development through commercial launch. He has led process development activities at both small biopharmaceutical and large pharmaceutical organizations and was most recently the director of Manufacturing Sciences and Technology at Bristol-Myers Squibb. There, he led an organization that successfully commercialized Yervoy® and Nulojix® and provided post-commercial process support for Orencia® in addition to other late-stage programs. Prior to Bristol-Myers Squibb, Dr. Shukla worked in the process development organization at Amgen Inc. He is the author of over 30 publications in the bioprocessing area and also serves on the journal editorial boards of Bioprocess International and Biotechnology and Applied Biochemistry. Dr. Shukla has presented keynote lectures at international conferences in the field of process development and manufacturing of biopharmaceuticals. He holds a doctorate in chemical and biochemical engineering from Rensselaer Polytechnic Institute.