biotechnology, assay validation expert consultant resume
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Resume of EIG, Ph.D. Consultant
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  • Medical
  • Biotechnology
  • Healthcare
  • Pharmaceutical

This expert holds a Ph.D. in Biochemistry and Molecular Biology, earned through the Mayo Clinic College of Medicine in Rochester, MN.

This expert holds a B.A. in Microbiology, earned through the Miami University in Oxford, OH.

Biotechnology, Assay Validation Expert Consultant Resume
 

This expert has extensive knowledge in business development, assay validation, molecular profiling, and clinical oncology. Additionally, this expert has knowledge in nucleic acid development and validation.

Other areas of emphasis for this expert include flow cytometry, cell proliferation, stem cells, and animal modeling. This expert also has keen interests in the fields of biotechnology research, tumor biorepositories, biobanking, and prospective blood collection. Also included in this expert's interests are the fields of optimized isolation protocols, molecular biology, and biochemistry consulting.

This consultant's experience includes strategic planning and analysis, multi-site project and program management, molecular research, leadership, and clinical trials. This expert also has experience in troubleshooting, problem solving, negotiations, presentations, and relationship building. Other areas of expertise this consultant has include global networking, process and procedural improvements.

Consultant, Kevin Kennedy Associates Inc.

Providing expertise in biochemistry, molecular biology, assay validation, molecular profiling, biotechnology research consulting, cancer research, and related expertise to a wide variety of clients.

 

Manager of Clinical Programs, reference lab testing firm

Organized and coordinated all aspects of complex molecular analysis programs for $12M CLIA certified laboratory specializing in ELISA, Immunohistochemistry, Microarray Gene Expression Profiling, and tumor banking. Established and cultivated new and existing client relationships with pharmaceutical companies conducting clinical trials. Drafted and oversaw execution of CDAs. Conducted extensive research into existing literature and proposed new assays for clinical trial protocols. Identified potential to customize any previously unavailable assay. Determined program specifications, appropriateness and accuracy of experiment, and need for any additional service not present in client’s original scope. Prepared budgets, pricing quotes, and Material Service Agreements (MSAs). Major Contributions: Generated +$2.5M in revenue in 5 months, forging relationships with 14 new clients. Spearheaded discovery and laid ground work for acquisition of competing new platform; critical to maintaining Veridex platform as only 1 FDA approved to measure circulating tumor cells. Established collaborative relationship with key platform client, attained and positioned CDA, and set initial meetings; co-designed experiments, and identified tissue samples for client’s use. Researched, identified, and customized key assays to fit specific needs of clients, directing and collaborating with technicians to troubleshoot, and determine validation timeline and platform.

 

Director of Progenitor Cells, Program Manager of the Biospecimen Core Resource (BCR) for the Cancer Genome Atlas Project (TCGA), International Genomics Consortium (IGC), Phoenix, AZ

Launched Stem Cell Program for non-profit arm of Caris-MPI. Oversaw preparation for sequencing and characterization of gene expression profiles of Glioblastoma, Lung, and Ovarian cancers. Defined and developed protocols for isolation of stem cells from pancreatic and colon cancers. Orchestrated incorporation of tumor samples from established repositories into production line for molecular extractions of RNA and DNA. Managed Biospecimen Biorepositories containing 10,000 blood and tissue samples. Corresponded daily with deputy director of National Cancer Institute (NCI). Compiled clinical data related to tumor samples. Maintained adherence to HIPPA guidelines. Represented BCR before National Steering Committee, traveling extensively to their key meetings. Major Contributions & Highlights: Selected to administer major portion of National Cancer Institute’s Cancer Genome Atlas Project. Aided dozens of worldwide institutions in obtaining Institutional Review Board documentation, and approval and execution of MTAs to enable submittal of their samples to BCR. Obtained clinical data from 100 patient samples from 5 geographically dispersed institutions in 48 hours, designing innovative and streamlined 3-tiered approach to collection. Authored comprehensive training manual outlining all policies and requirements for existing and prospective participants in Cancer Genome Atlas; deployed by NCI to all institutions.

 

Visiting Scientist, major medical research organization

Consulting on Proteomics projects. Assisted in development of cancer vaccine strategies. Available to answer and train research fellows on alternative splice variant validation, Quantitative PCR, microarrays, monoclonasl antibody development, Immunohistochemistry optimization, Western Blots, ELISA development, tissue culture, transformation, protein purification using FPLC or tag systems, Yeast two hybrid, Southern Blotting, and cloning.

 

Senior Research Fellow, major medical research organization

Splice variant validation for Pancreatic Cancer using patients’ sera, pancreatic juice, and tissue; ELISA development and optimization for detection of splice variants.

 

Research Fellow, major medical research organization

Environmental effects on Alternative splicing in Pancreatic Cancer using high throughput techniques (microarray analysis, Real-time PCR, and siRNA), Monoclonal Antibody Development for G-Protein Coupled Receptors and newly identified splice variants; recombinant protein generation and purification.

 

High throughput Scientific Director, major medical research organization

Established a High throughput facility for the Mayo Clinic Arizona Campus; Trained investigators in Microarray and Real-Time PCR methodologies and data analysis; responsible for annual budget, ordering, and maintaining lab.

This expert has authored numerous publications on topics related to biochemistry, molecular biology, lung cancer, breast, colon, and pancreatic carcinoma, microarray data analysis, endocrinology, and more.

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