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Director R&D

Location:
Apex, NC
Posted:
June 15, 2017

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Resume:

Goal-driven Research and Development Scientist seeking fast paced environment

SUMMARY

Goal-driven professional with more than 20 years as Research Scientist and over 15 years leading and managing R&D and Diagnostic Laboratories. Proven success driving groundbreaking advances in molecular and microbiological diagnostic assays development from concept to commercialization.

Track record of delivering and accomplishments:

Designed, developed, and validated a novel clinical diagnostic test platform considered the new gold standard assay for Bartonellosis in human and veterinary medicine.

Created a Biotechnology company, launched and grew commercial services, and drove discoveries in emerging infectious diseases through IVD test development and clinical research.

Expanded the scope of diagnostic services in a CLIA accredited diagnostic Company and in one of the world’s leading reference laboratories for animal vector-borne diseases.

Developed a strong and recognized presence in the national and international scientific and medical communities by publishing over 110 peer-reviewed manuscripts, more than 20 lectures at international and national forums, and by publishing 7 book chapters in three countries.

EDUCATION

Ph.D., University of Puerto Rico – Mayaguez, PR

Specialty: Molecular microbiology/biotechnology

MS, University of Puerto Rico – Mayaguez, PR

Specialty: Analytical Chemistry

BS-Licentiate in Chemist – Universidad Nacional de Córdoba –Córdoba, Argentina

Specialty: Biological Chemistry

PROFESSIONAL SKILLS

Extensive experience in basic and translational research, and in technology and process development.

Strong experience in molecular and immunological assays/diagnostic tests development (from proof of concept to delivery of diagnostic products).

Excellent in innovation management, creation and execution of initiatives, processes, and team building to support strategic goals aimed at increase quality of services, operational efficiency, and/or to expand products/services.

Strong experience in local, State, and Federal regulatory compliance regulations, including validation and implementation of quality control methods and metrics toward GLP and cGMP, and HIPAA, CLIA/COLA accreditation.

Strong risk management, problem-solving, and organizational skills, and excellent in communication and building interpersonal relationships.

Fully bilingual in English and Spanish, and proficiency in Italian and Portuguese.

PROFESSIONAL EXPERIENCE

North Carolina State University – Raleigh, NC 2003-Present

Principal Investigator Intracellular Pathogens Research Laboratory (2005-present)

Direct and manage intra and extramural research and clinical projects.

Provide research services outsourcing on a contract basis (CRO) for biological assay development, commercialization, and preclinical research.

Design, develop, and validate molecular and immunological (IFA, ELISA) diagnostic platforms (from proof of concept to delivery of diagnostic products).

Identify and characterize novel therapeutic agents and biomarkers.

Laboratory management and personnel training, including technicians, medical professionals and scientists.

Galaxy Diagnostics, Inc. – RTP, NC 2009-present

Technical Supervisor (high complexity testing) and Co-Director of R&D

Select appropriate tests methodologies for each diagnostic test service.

Validate test procedures performance and establish laboratory performance criteria.

Establish a QC program appropriate for testing and the acceptable levels of analytical performance.

Resolve technical problems and ensuring remedial actions when test systems deviate from established performance specifications.

Develop and execute PT program and personnel competency (Identifying training needs and education).

Develop of new molecular and serological clinical diagnostic tests.

Improve diagnostic platform performance through NIH funding,

North Carolina State University – Raleigh, NC 2010-2014

Co-Director Vector-Borne Diseases Diagnostic Laboratory

Directed molecular test operations and staff.

I established quality control management by implementing QA/QC protocols and metrics.

Developed plans toward expanded product and services.

Developed and executed PT program and personnel competency.

Additional sources of reference

http://www.researchgate.net/profile/Ricardo_Maggi

https://www.linkedin.com/pub/ricardo-g-maggi/7/b12/519

http://www.galaxydx.com/web/our-team/



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