In my role as a Senior Molecular Biologist at SigSci, I develop and transition molecular biology-based scientific solutions to client-based challenges. My day-to-day involves guiding and performing experimental design, laboratory work, and data analysis in support of forensics-based, CBRNE, molecular and microbiology-based research and development projects. I have served in Principal Investigator, Technical Leader, and Subject Matter Expert (SME) roles, spanning forensics collection/detection applications, microbial and human genetic signature detection, human protein profiling and synthetic biology strategies, as well as gene expression projects. In addition, I serve in a surge laboratory and validation support role for DNA casework in our ANAB accredited Forensics Laboratory at SigSci. My areas of expertise include DNA forensics, touch DNA collection and method development, molecular-based pathogen identification/detection strategies, sequence-based workflows for MinION sequencing platforms, molecular assay development, scientific strategy development, as well as broad experience with quality assurance and proficiency test development, auditing, and management.My experience also includes direct technical communication with clients, drafting scientific proposals, technical reports and client meeting slides, manuscript preparation, data analysis summaries, staff supervision and project management roles. I have also served as a trainer / instructor of CBRNE topics, including lecture, lab practical, and field exercises.

• Established state-of-the-art CAP/CLIA clinical molecular diagnostics laboratory • Implemented soft infrastructure, automation and quality management processes (GLP) o Created CAP/GLP-compliant technical report, assay validation, and QA/QC documentation templates o Established quality management processes and documentation, such as corrective action, root cause analysis, material/sample/equipment tracking, assay trending databases, and protocol deviation reports o Internal auditor for CAP, CLIA, and GLP regulatory compliance• Led development, validation and implementation of molecular and genetic-based clinical diagnostic testing platforms and assays• Provided technical/regulatory review of clinical assay results and communicated finalized results to physicians• Participated in biotech clinical trials and documentation in support of FDA 510K submissions

• Analyzed pharmaceutical and basic scientific/medical research results related to medical causation issues for use in product liability (medications and medical devices) and mass tort litigation • Daily use of critical thinking and analytical writing skills to produce scientifically decoded work product to be utilized for defense case support and medical expert preparation • Provided scientific/clinical technical direction and recommendations for court exhibits and strategic arguments• Project management responsibilities included organizing, assigning, and ensuring deadline accomplishment for Pfizer counsel and scientific team case tasks• Provided re-assessment of resources and personnel for tight deadlines • Ability to successfully complete complex and voluminous projects under intensive deadlines and pressurized situations

Labs-Inc./Laboratories At Bonfils/Immunological Associates of Denver (same organization), now part of VRL Eurofins• Provided leadership and managed personnel and projects related to HLA testing in an ISO 9001:2000 certified lab for bone marrow, cord blood, NMDP, and research contracts• Implemented and monitored lab processes and documentation improvements to enable ISO 9001:2000 registration achievement• Performed internal quality assurance audits to ensure CAP, CLIA, ASHI, and ISO compliance• Reported quality indicators and quality management categories, such as corrective action, root cause analysis, and quality indicator deficiency trending• Prepared daily work scheduling to ensure operational efficiency• Interpreted/evaluated test results and communicated finalized reports/results to physicians• Served as research liaison between lab and biotech companies for beta testing immunodiagnostic tests, new platforms and automation• Formulated and guided R&D projects relating to immobilized DNA hybridization, DNA isolation techniques, and molecular technique automation• Authored departmental operating procedures, contract proposals, and product feasibility reports• Utilized HLA sequencing, molecular Luminex RSSO, immobilized probe membrane hybridization methodologies, and PCR-based forward SSOP and SSP methodologies• Maintained vendor relations and cost analysis of testing• Maintained departmental quality control and assurance programs• Monitored employee performance via regular evaluations• Trained personnel on resulting, reporting and technical procedures

• Created and established HLA Molecular Typing Laboratory and associated quality assurance and molecular training programs• Developed, implemented, and troubleshot new molecular diagnostic testing techniques and automation • Conducted various independent research projects relevant to organ transplantation, including the use of flow cytometry, RNA, cytokine, SSOP, SSP, ELISA, cell culture, and other PCR-based techniques • Led research projects which included:o Development of discriminatory PCR-based assay for Celiac Disease and Ulcerative Colitis using specific HLA biomarkerso Developed method for extracting DNA from trace cell sources in serum for use in downstream nested PCR-based research assayso Optimized intracellular cytokine staining method related to dendritic cell tumor vaccine researcho Created specific DNA assay controls for rare HLA allele sequences by mutagenizing cloned HLA sequences• Utilized ELPHATyper and Dynex DIAS liquid handling systems, Auto-LiPA automated chemiluminescent detection system, and flow cytometry and cell sorting system platforms