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BTEC Fellows
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
Ray Anover currently manages the biologics development and manufacturing technical operations for Eiger BioPharmaceuticals in Palo Alto, California.
Mr. Anover has more than 25 years of experience in the biotech industry. Prior to joining Eiger, he recently held a similar role at at Veloxis Pharmaceuticals in Cary, NC, which is a wholly owned subsidiary of Asahi Kasei Pharma based in Tokyo Japan. He also 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).
Jeff Odum, CPIP
Jeff Odum, a globally recognized subject matter expert in biomanufacturing facilities, is currently the practice lead for ATMPs* and Biologics at Genesis AEC, a design and construction firm that serves the life sciences industry. A Certified Pharmaceutical Industry Professional (CPIP), he has over 30 years of experience in the design, construction, and operation of facilities in the biotechnology industry.
A recognized expert in biopharmaceutical manufacturing assets, Mr. Odum has authored more than 60 articles and four reference books on subjects related to project management, GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities. He regularly speaks at international industry forums and conferences, presenting on topics relating to next-generation facility design, bioprocess manufacturing, project management, and GMP compliance.
Mr. Odum has served as the North American education advisor to the International Society of Pharmaceutical Engineering (ISPE) and has led development teams for industry baseline and reference guides focused on ATMPs and biotechnology manufacturing and project management. He is a member of the ISPE global technical training faculty where he develops and delivers biomanufacturing-focused course content. He has led training efforts in 15 countries, including training for global regulators from the U.S. FDA, Health Canada, Thailand FDA, and the Chinese SFDA.
He holds a bachelor’s degree in mechanical engineering from Tennessee Technological University and a master’s degree in engineering with a minor in engineering management from the University of Tennessee–Knoxville.
*ATMP is an acronym for advanced therapy medicinal product, which is a gene therapy, somatic cell therapy, or tissue-engineered product.