Aaron Lefebvre,Phd,Hcld(Abb),Nrcc-Tc Email & Phone Number

Texas, United States

Texas, United States

Washington, Dc, Us

Satellite Beach, Florida, Us

• Subject matter expert on application of analytical methods, data interpretation, and composition of scientific, quality system, and regulatory documentation during development, validation, and analytical/clinical performance studies of IVD medical devices.• Provide operational leadership including cost analysis and process optimization for both clinical and contract research organizations.

Satellite Beach, Florida, Us

• Dual board-certified clinical laboratory High Complexity Lab Director; HCLD(ABB), NRCC-TC. Provide laboratory directorship, scientific leadership, and laboratory consultation services including molecular diagnostics, including pharmaco- and cancer genomics.• Perform mock inspections for clinical laboratories according to applicable regulatory bodies including CMS, CAP, and COLA.

Coppell, Texas, Us

• Independently developed and implemented all internal policies and procedures for documentation of analytical and clinical performance studies for clients pursuing US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or 510(k) approval of in vitro diagnostics. • Independently developed clinical performance study protocol template for human subject testing of IVD medical devices in accordance with 21 CFR.• Directed development, implementation, and management of quality management system for contract research laboratory in pursuit of ISO/IEC 17025:2017 certification by ANSI National Accreditation Board (ANAB).• Directed contract research services laboratory staff in the application of analytical methods, analysis and interpretation of scientific data, and preparation of written evaluations related to assigned projects; contract research projects focused on the fields of immunoassay, molecular diagnostics, and microbiology.• Served as subject matter expert on application of analytical methods and data interpretation during development, validation, and analytical/clinical performance studies of IVD medical devices.• Reviewed experimental design, scientific data, and written evaluations prepared by contract research staff prior to dissemination to contract research clients, including study protocols, line data, and results reports related to analytical performance studies of IVD medical devices.• Coordinated and monitored contract research personnel efforts toward attaining organizational goals including project turnaround time, costs, and deliverables.• Independently developed standards for contract research project cost analysis, project pricing structures, and statement of work (SOW) proposals.• Responsible for presentation and negotiation of all statement of work (SOW) project proposals and pricing to contract research clients.• Composed and/or reviewed technical and scientific text for business web site and marketing materials.

Coppell, Texas, Us

• Acting Laboratory Director responsible for directing overall operation and administration of DevLab’s CLIA-certified clinical diagnostic laboratory (CLIA# 45D2187554).• Led DevLab’s CLIA-certified clinical diagnostic laboratory to successful achievement of laboratory accreditation by the College of American Pathologists (CAP).• Independently led development and directed implementation of complete 42 CFR Part 493 & HIPAA compliant quality management system for start-up of DevLab’s clinical diagnostic laboratory.• Implemented and led quarterly quality management meetings with laboratory staff to discuss QA/QC trends, root cause analysis, customer satisfaction, and opportunities for process improvement.• Responsible for supervision of Technical Supervisor and/or General Supervisor in accordance with CLIA ’88 regulations.• Advised clinical laboratory supervisors in analysis and troubleshooting of quality control data and data interpretation for dissemination to ordering physicians.• Independently reviewed data and results and reported COVID-19 testing data to state and local public health authorities as required by law.• Provided verbal communication to patients through clinical consultation of reported results for direct-to-consumer COVID-19 testing.• Independently composed DevLab’s clinical diagnostic laboratory comprehensive collection manual.

• Acting CLIA Laboratory Director responsible for directing overall operation and administration of four (4) clinical laboratories managed by Manacare Health; laboratory test menus included clinical chemistry and hematology, toxicology screening and confirmation, respiratory and gastrointestinal molecular diagnostic testing, and pharmacogenetic testing. o Axis Professional Labs, LLC (CLIA# 37D2122926); clinical chemistry and hematology o Beta BioSciences, LLC (CLIA# 45D2113281); molecular diagnostic and pharmacogenetic testing o Clearview Diagnostics (CLIA# 45D2104045); clinical chemistry and hematology o Quality Metrics Laboratories, LLC (CLIA# 45D2105931); clinical chemistry and hematology/toxicology screening and confirmation• Led Beta BioSciences, LLC though successful inspection by Centers for Medicare & Medicaid Services (CMS).• Led Clearview Diagnostics to successful achievement of laboratory accreditation by the Commission on Office Laboratory Accreditation (COLA).

• Oversaw general laboratory operations and quality management of all clinical laboratories owned and managed by Manacare Health.• Led development and directed implementation of complete 42 CFR Part 493 and HIPAA compliant quality management system for four (4) clinical laboratories operated by Manacare Health, including blood chemistry/hematology, urine toxicology, and molecular & pharmacogenetic testing.• Served as subject matter expert on quality management, directing a team of mid-level managers responsible for quality assurance and laboratory operations across the Manacare Health laboratory system.• Served as a subject matter expert in applying analytical methods and techniques to interpret data in clinical laboratory testing across all clinical laboratories operated by Manacare Health.• Coordinated with CEO and laboratory ownership to expand laboratory services, including setup or relocation of new laboratories operated by Manacare Health, management of third-party laboratories, and expansion of laboratory test menus.• Coordinated with Accounting department to monitor laboratory costs and ensure all laboratories operated within financial goals.• Coordinated with phlebotomy manager to monitor specimen integrity and rejection rates, improve performance of phlebotomists, and reduce specimen rejection rates through staff training and/or pre-analytical process improvement. • Coordinated with Human Resources to monitor laboratory staffing needs, compose laboratory staff job listings, conduct potential new hire interviews, and conduct disciplinary action related to laboratory staff, when required.• Member of College of American Pathologists (CAP) site inspection team.

Carrolton, Tx, Us

• Acting Laboratory Director responsible for directing overall operation and administration of Real Time Laboratories’ CLIA-certified clinical diagnostic laboratory (CLIA# 45D1051736).

• Board-certified High Complexity Laboratory Director providing laboratory directorship, scientific leadership, and laboratory consultation services.• Independently performed consulting for clinical laboratories with focus on urine toxicology and pharmacogenetic testing; consulting services included independent development and/or review of clinical laboratory test menus and policies and procedures, validation support services, recommendations for instrumentation to expand test menus, and review of quality control and quality assurance data.• Performed mock inspections for clients, with focus on urine toxicology, to ensure clinical laboratories met regulatory requirements; applicable regulatory bodies included CMS, CAP, and COLA.

Dallas, Texas, Us

• Oversaw development, validation, and optimization of analytical test methodologies for the clinical laboratories, including toxicology screening, LC-MS/MS confirmation, hematology/blood chemistry, and pharmacogenetics laboratories. • Served as a subject matter expert on applying analytical methods and techniques to interpret data in clinical toxicology and pharmacogenetic testing.• Coordinated with clinical laboratory departmental supervisors to adopt substantive goals, including identification of opportunities for process improvement and adoption of specific analytical test methodologies and instrumentation.• Independently validated multiple LC-MS/MS confirmation methods for detection of a wide array of drugs and/or their metabolites in both human urine and saliva.• Independently composed a tested compound information packet disseminated to all LC-MS/MS analysts that included detailed background, use, technical information, and analysis guidelines for all tested compounds.• Coordinated with the Quality Manager to ensure compliance of all clinical laboratory validations with COLA accreditation requirements• Responsible for composition and/or review of validation packets, technical protocols, and draft Standard Operating Procedures for both the toxicology and pharmacogenetics laboratories.• Assisted in technical support and troubleshooting of all methods and instrumentation in the LC-MS/MS confirmation and pharmacogenetics laboratories.

• Directed forensic databasing laboratory operations, including setting batch completion deadlines and prioritization of work to maintain customer satisfaction, meet contract requirements, and achieve company revenue goals.• Directed, implemented, and supervised process improvements based on analysis of production data and validation or optimization of laboratory processes that directly resulted in a 50% increase in first pass success rates, a greater than 50% reduction in turnaround time and an increase in monthly output per FTE by approximately 150% in the forensic databasing laboratory.• Supervised and managed performance of a team of 20+ Laboratory Technicians and DNA Analysts and through multivariate operational and efficiency improvements, reduced team to a total of four (4) fully cross-trained DNA Analysts. • Provided scientific leadership and oversaw development and implementation of the Cellmark Forensics’ BioTracks local forensic databasing product offered to local law enforcement agencies, including development of all laboratory processes.• Coordinated with the Laboratory Director and Quality Manager to ensure compliance of the forensic databasing laboratory with company quality assurance guidelines as well as accreditation requirements (ASCLD/LAB-International; ISO/IEC 17025:2005, FBI QAS). • Independently developed cost analysis tools for provision to the Director of Operations and other members of upper management to assist in making informed decisions on forensic databasing contract bid proposals.

• Directed R&D operations, including assignment of traditional research and process improvement projects, setting of project deadlines, oversight of data analysis and interpretation, and review of written documentation.• Supervised R&D personnel efforts toward attaining organizational goals such as validation and implementation of optimized and cost-efficient protocols for use in the forensic database and casework laboratories and training on analytical processes used by the laboratory to improve staff troubleshooting and reduce re-work rates.• Directed and supervised implementation of all procedures developed, validated, and/or optimized by Research Associates and monitored implemented procedures for effectiveness.• As Principal Investigator, and in collaboration with external agencies, was awarded NIJ grant funding for use in collaborative research project. Directed and oversaw federally funded research executed by Research Associates and external agencies, including monitoring of grant finances and regular reporting to NIJ.• Served as subject matter expert on applying analytical methods and techniques to interpret data in forensic DNA testing.• Provided outside expert review of both potential research grants (i.e., NIJ) and manuscripts submitted to forensic journals (i.e., Journal of Forensic Sciences).• Independently performed technical review and statistical analysis for forensic relationship testing cases processed in the forensic casework laboratory and generated by external entities.• Testified as an expert witness on forensic relationship testing cases.• Directed and supervised M.S. and Ph.D. degree candidates in their collaborative research performed towards attaining their degrees.• Directed and supervised annual summer interns on research projects undertaken at Cellmark Forensics as part of the requirements for completion of their degree.

• Served as a subject matter expert on applying analytical methods and techniques to interpret data in forensic DNA testing.• Provided scientific leadership in the field of biochemistry, molecular biology, and forensic DNA analysis. Directed, implemented, and oversaw process improvements based on analysis of production data and validation or optimization of laboratory processes in the forensic databasing and casework departments.• Provided scientific leadership during major business consolidation project involving relocation of the forensic databasing laboratory from Nashville, TN to Dallas, TX facility. Tasks performed during this major project included process optimization and independent validation and implementation of all instrumentation and optimized procedures.• Utilized interpersonal skills to collaborate with executive leadership to identify and negotiate research opportunities consistent with short- and long-term corporate goals.• Directed and oversaw execution of research projects performed by other members of the R&D team, including project planning, data synthesis, data analysis, and interpretation of results. Projects included process optimization, process validation, and assay development.• Independently designed, conducted, implemented, and oversaw major scientific studies or projects through validation, optimization, and implementation of various protocols in the forensic databasing and casework departments for use in production of STR DNA profiles.• Developed technical protocols and Standard Operating Procedures for use in the forensic databasing and casework laboratories.• Monitored forensic databasing personnel efforts toward attaining organizational goals such as reduced batch re-work rates and turnaround time.

• Served as a subject matter expert on applying analytical methods and techniques to interpret data in forensic DNA testing.• Provided scientific leadership in the field of biochemistry, molecular biology, and forensic DNA analysis. Directed, implemented, and oversaw process improvements based on analysis of production data and validation or optimization of laboratory processes in the forensic databasing and casework departments.• Independently designed, conducted, implemented, and oversaw major scientific studies or projects through validation, optimization, and implementation of various protocols in the forensic databasing laboratory for use in production of STR DNA profiles.• Developed technical protocols and Standard Operating Procedures for use in the forensic databasing and casework laboratories.• Collaborated with upper management to develop a daily monitoring program for re-work and turnaround analysis to measure effectiveness of the forensic databasing laboratory and to ensure company goals were consistently met.• Monitored forensic databasing personnel efforts toward attaining organizational goals such as reduced batch re-work rates and turnaround time.• Performed daily data collection, analysis, and interpretation of production metrics in the forensic databasing laboratory, such as batch re-work rates and turnaround time, to identify opportunities for process improvement including assay validation, optimization or laboratory processes, and improved staff training on troubleshooting laboratory processes and automation.• Independently prepared and presented findings to upper management and laboratory ownership on results of validation, troubleshooting, and optimization of forensic DNA testing processes.• Proficient in programming and use of a wide array of liquid handling and forensic DNA processing automation platforms.• Responsible for troubleshooting of production data and instrumentation company wide.

Us

• Served as a subject matter expert on applying analytical methods and techniques to interpret data in forensic DNA testing.• Provided scientific leadership in the field of biochemistry, molecular biology, and forensic DNA analysis. Directed, implemented, and oversaw process improvements based on analysis of production data and validation or optimization of laboratory processes company wide.• Independently designed, conducted, implemented, and oversaw major scientific studies or projects through validation, optimization, and implementation of various protocols in the forensic databasing laboratory for use in production of STR DNA profiles.• Developed technical protocols and Standard Operating Procedures for use in the forensic databasing and casework laboratories.• Performed daily data collection, analysis, and interpretation of production metrics in the forensic databasing laboratory, such as batch re-work rates and turnaround time, to identify opportunities for process improvement including assay validation, optimization or laboratory processes, and improved staff training on troubleshooting laboratory processes and automation.• Proficient in programming and use of a wide array of liquid handling and forensic DNA processing automation platforms.• Responsible for troubleshooting of production data and instrumentation company wide.• Reviewed and approved data analysis, interpretation, and conclusions for DNA paternity cases (~1000 cases).• Contributed to training and management of forensic databasing laboratory staff.• Contributed to day-to-day operations of the forensic databasing laboratory as needed through performance of wet lab testing as needed as well as STR data analysis and data package reporting.

Us

• Served as a subject matter expert on applying analytical methods and techniques to interpret data in forensic DNA testing.• Collaborated with management to develop a daily monitoring program for re-work and turnaround analysis to measure effectiveness of the forensic databasing laboratory and to ensure company goals were consistently met.• Directed, implemented, and oversaw process improvements based on analysis of production data and validation or optimization of laboratory processes that directly resulted in a decrease of re-work rates from greater than 30% of total samples to below 10%, while increasing monthly output by 220%. Utilized interpersonal skills to present evidence-based recommendations and negotiate with upper management for implementation of new or improved processes.• Independently designed, conducted, implemented, and oversaw major scientific studies or projects through validation, optimization, and implementation of various protocols in the forensic databasing laboratory for use in production of STR DNA profiles.• Developed technical protocols and Standard Operating Procedures for use in the forensic databasing and casework laboratories.• Performed daily data collection, analysis, and interpretation of production metrics in the forensic databasing laboratory, such as batch re-work rates and turnaround time, to identify opportunities for process improvement including assay validation, optimization or laboratory processes, and improved staff training on troubleshooting laboratory processes and automation.• Proficient in programming and use of a wide array of liquid handling and forensic DNA processing automation platforms.• Responsible for troubleshooting of production data and instrumentation company wide.• Contributed to day-to-day operations of the forensic databasing laboratory as needed through performance of wet lab testing as needed as well as STR data analysis and data package reporting.

Ph.D., Biochemistry & Molecular Biology

B.S., Biology