Expert in IVD Assays and Diagnostic Tests Development
IVD (in vitro diagnostics)
clinical laboratory regulation
blood assay diagnostic instrumentation
CLIA-88 (Clinical Laboratory Improvement Amendments of 1988)
clinical laboratory regulation
quantitative risk analysis (risk assessment)
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
|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|
|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.|
|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|
|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.