Molecular Biologist Expert in Clinical Diagnostic Research and Development, CLIA Compliance, DNA Repair and Oncology

Technical Consultant #1952

Ph.D. Molecular Biologist and biotechnology manager with extensive experience in clinical diagnostic research and development, next- generation sequencing, DNA repair, oncology, translational medicine, and industrial microbiology, as well as:
CLIA, CLEP, COLA, CAP, JCAHO, GLP, HIPAA, LIMS, and FDA 510k regulatory requirements.
DNA repair, gene therapy, gene repair and editing.
Oncology research, including small molecule aptamers and translational medicine.
Industrial microbiology and synthetic biology strain engineering to improve peptide production in E. coli.
CLIA accreditation and compliance for clinical diagnostic laboratories.
Collaboration with physicians and researchers to explore and market new diagnostic opportunities.
Management experience with research and laboratory operations.
Next generation sequencing (NGS) technology experience for genome, exome, RNA-sequencing.
Clinical diagnostic assay research for Borrelia burgdorferi, Lyme disease.
Expert Panelist with the Rare Genomics Institute, which helps patients with orphan diseases initiate and fund personalized research projects through a dedicated microfunding platform and highly-selective network of leading academic scientists and commercial institutions.

Undisclosed Company, Senior Scientific Affairs Manager, 2017 - Present

Leading the Medical and Scientific Affairs in Sequencing and NGS activities for the U.S. Affiliate.
Primary objectives are focused on the development and facilitation of relationships with the medical and scientific community to communicate technology-related information to investigators and institutions, conducting advisory boards, and engaging in collaborations for sequencing focused studies.
Additional responsibilities include the management of projects in alignment with team strategies and identifying novel trends, new emerging technologies and potential partnering opportunities.

Genetic Diagnostic Laboratories, Buffalo, NY, Philadelphia, PA, 2014 - 2017

Director of Research and Development (Advanced Laboratory Svcs, Inc.,)

Full-service cytogenetic testing laboratory, State of New York Department of Health/CLEP/CLIA-licensed to perform cytogenetic services including: chromosome analysis, extended and high resolution banding, fluorescent in situ hybridization (FISH), and prenatal aneuploidy detection.
Operations supervisor for laboratory, new assay validation, and sales/marketing efforts.
Management of diverse laboratory team for the initiative to validate multiple hematology/oncology FISH panels to diagnose myeloid leukemia, lymphomas, myelodysplastic syndrome, and myeloproliferative disorders. Successfully added histology laboratory and diagnostic category for specialty nerve biopsy assays.
Prepared FDA 510k pre-submission for laboratory- developed IVD test, and organized tasks for successful certification by The Joint Commission Laboratory Accreditation Program.

Otogenetics Corporation, Atlanta, GA, Chief Operating Officer, 2012 - 2014

Next generation sequencing (NGS) technology for genome, exome, RNA, and a variety of clinical disease panels.
Development of commercialization of large-scale genetic diagnostic information in a disease-specific manner (e.g., deafness-causing, cancer-related, for both research and clinical purposes.

Rare Genomics Institute, St. Louis, MO, Expert Panelist, 2012 - Present

Assist patients with orphan diseases initiate and fund personalized research projects through a dedicated microfunding platform and highly-selective network of leading academic scientists and commercial institutions.

Advanced Laboratory Services, Sharon Hill, PA, Associate Director, 2011 - 2012

Participate in the daily operations of a medium to high complexity clinical diagnostic laboratory.
Developing new-to-market diagnostics while providing high quality services for our clients and their patients.
Contribute to research, development, sample processing, marketing, and management of 12-member clinical and research team.

E.I. DuPont de Nemours & Co., Wilmington, DE, Molecular Biologist, 2008 - 2011

University of Delaware, Newark, DE, Doctoral Candidate, 2002 - 2008

Targeted gene repair in mammalian cells using single-stranded DNA oligonucleotides in an applied genomic laboratory.
Novel use of single-stranded DNA oligonucleotides to selectively kill tumor cells.
Research Assistantship: Delaware Center for Translational Cancer Research.

Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, 2000 - 2002

Senior Laboratory Technician, Molecular Microbiology and Immunology Laboratory
Studied the genetic diversity of Borrelia burgdorferi, and abiotic and biotic factors effecting the life cycle of Borrelia.

Academic and Professional Affiliations

Awards

Publications and Patents

Author and Co-Author of numerous publications in peer reviewed journals - subject matters:

Polypeptide self-assembly enhances its expression, processing, and function in a Bionanotechnology application.
Using bleomycin to stimulate targeted gene repair activity in mammalian cells.
A specific guanosine-rich oligonucleotide, capable of forming stable quadruplex structures selectively blocks proliferation and induces apoptosis in esophageal tumor cells.
Single-strand DNA Oligonucleotides increase sensitivity of cancer cells to chemotherapeutic agents.
Mammal Diversity and Infection Prevalence in the Maintenance of Enzootic Lyme Disease.
Spotted-fever group Rickettsia in Dermacentor variabilis.
DNA damage and homologous recombination regulate the frequency and process of targeted gene repair.
Abiotic and biotic factors affecting the enzootic cycle of Lyme disease.
Environmental factors contributing to the prevalence of Lyme disease in the white-footed mouse populations.
2 U.S. Patents.