Expert Details

Expert in IVD Assays and Diagnostic Tests Development

Expert ID: 733788 North Carolina, USA

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Expert's areas of expertise include the following:

IVD (in vitro diagnostics)
clinical laboratory regulation
molecular diagnostics
blood assay diagnostic instrumentation
assay development
CLIA-88 (Clinical Laboratory Improvement Amendments of 1988)
clinical laboratory regulation
quantitative risk analysis (risk assessment)
laboratory management
GLP (Good Laboratory Practice)
innovation management (new product development)

Expert may consult nationally and internationally, and is also local to the following cities: Raleigh, North Carolina - Greensboro, North Carolina - Durham, North Carolina - Winston Salem, North Carolina - Fayetteville, North Carolina - Cary, North Carolina - High Point, North Carolina - Greenville, North Carolina - Rocky Mount, North Carolina

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Education

Year Degree Subject Institution
Year: 2001 Degree: PhD Subject: Molecular Microbiology-Biotechnology Institution: UPR
Year: 1996 Degree: MS Subject: Environmental Chemistry Institution: UPR
Year: 1988 Degree: BS Subject: Proteomics Institution: UNC

Work History

Years Employer Title Department Responsibilities
Years: 2003 to Present Employer: Undisclosed Title: Research Associate Professor Department: Clinical Sciences Responsibilities: Expert designed and led intra- and extramural research and clinical projects (with combined budget of over $2M) aiming at the identification and characterization of zoonotic diseases. He also provides research services outsourcing on a contract basis (CRO) for biological assay development, and preclinical research. He designs, developed, and validated clinical molecular and immunological diagnostic assay platforms aiming at emerging infectious diseases. He designed and characterized serological markers (for vaccines application) and non-traditional antibiotic therapeutic agents against selected vector-borne pathogens. Additionally, Expert managed the training and work of over 60 personnel (including technicians, undergraduate and graduate students, physicians, veterinarians, scientists, and post doctorates.
Years: 2009 to Present Employer: Undisclosed Title: CLIA Technical Supervisor Department: Responsibilities: Expert generated documents in response to Company requests, operational requirements, Personnel actions, regulatory requirements, quality management system components, and good clinical diagnostic and health laboratory setting practices. He analyzed data derived from high complexity testing to ensure appropriateness and accurate testing and reporting. He also forecasted the Company’s needs, synthesizing commercial and technical information to generate plans and solutions toward achieving strategic goals for expanded product and services. Responsibilities also included the management of complex grants and projects, applying and evaluating milestone-based performance objectives and good judgement for prioritization of associated tasks. Additionally, he forecasted potential organizational and budgetary problems, and to develop strategic planning and inter-company negotiations. He led the design, development, and validation of CLIA-compliant IVD and microbiological diagnostic systems for medical applications, and the establishment of QC metrics and protocols. He also handled personnel management in projects aimed at development of new diagnostic assays.
Years: 2009 to 2014 Employer: NCSU Title: Director Molecular Operations Department: Vector-Borne Diseases Diagnostic Laboratory Responsibilities: Expert directed molecular test operations. He was also tasked with improving the quality and scope of services. His responsibilities included management and training of technicians, graduate students, as well as post-doctorates and professionals (veterinarians, scientists, and clinicians).
Years: 2002 to 2003 Employer: Biopolo Title: Chief Researcher Department: Biotechnology Division Responsibilities: Expert was responsible for the development of recombinant DNA platforms (genetic manipulation of yeasts and expression vectors construction) for biotechnological applications.

International Experience

Years Country / Region Summary
Years: 1996 to 2003 Country / Region: Caribbean Summary: Designed and led intra- and extramural environmental impact assessment research projects.
Years: 1992 to 1996 Country / Region: Caribbean Summary: Identification of biomarkers for biotechnological applications
Years: 1992 to 1996 Country / Region: Europe Summary: Biotechnology-Recombinant DNA
Years: 1992 to 1996 Country / Region: South America Summary: Environmental Chemistry

Career Accomplishments

Associations / Societies
o Institutional Animal Care and Use Committee (IACUC) Committee member-NCSU
o College of Veterinary Medicine Research Committee member-NCSU.
o Center for Comparative Medicine & Translational Research member-NCSU
o North Carolina Vector-Borne Diseases task Force. Member (2008-2011)
o Landmark Achievement of Launching a Startup Company Award. 2008. Technology Transfer Office, NCSU
o 2009 Edition of Marquis Who’s Who in America.
o Invited as member of The Science Advisory Board. Bioinformatics, LLC. 2008
o Award for best poster presentation (animal science research). 2012- 21st Annual NC State Undergraduate Research Symposium, NCSU. (Kristy M Casper author, RGM mentor)
o Award for best research in small animal infectious diseases. American College of Veterinary Internal Medicine (ACVIM). 2005
o Caribbean Stranding Network (CSN). Member (1990-1995).
o Caribbean Center for Marine Studies (CCMS). Scientific Advisory Board member and co-founder (1997-present).
o American Chemical Society (ACS). Member (1990-1995).
o America Society for Microbiology (ASM). Member (1996-present).
o Association of the Marine Laboratories of the Caribbean (AMLC). Member (2000-present).
o University of Florida President’s Council Member. Silver Member (2005-present)
o North Carolina Veterinary Medical Association (NCVMA). Member (2005-present)
o American Society for Rickettsiology (ASR). Member (2006-present)
Licenses / Certifications
Licentiate in Chemestry-Argentina
Awards / Recognition
Golden Key National Honor Society Award for Outstanding Scholastic Achievement and Excellence- Honor Member (1998-present).
Publications and Patents Summary
Expert has had over 110 peer-reviewed manuscripts published in national and international journals.
He has 5 invention disclosures submitted to the Office of Technology Transfer, NCSU
He has given over 20 lectures (by invitation) in national and international forums.

Language Skills

Language Proficiency
English Fully proficient
Spanish Fully proficient
Italian Fluent
Portuguese Knowledge

Fields of Expertise

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