Lab analyst with over 20 years experience

ELIZABETH ANNE TOMINEY

**** ************ *****, ******, ***** 78745

Phone: 805-***-**** Email: ********@*****.***

Experience:

Lead Laboratory Scientist / Laboratory Manager, Advanced Pain Care, Austin, Texas

April 2013 – January 2017

Clinical Laboratory:

Established and managed a CLIA certified laboratory performing high complexity testing utilizing Agilent 6460 triple quadrupole LC-MS/MS and GERSTEL automated extraction for confirmation of pain management drugs in urine.

Developed, optimized, and validated the methodology for assay and analysis of patient urinary drug screen samples for quantitative concentration confirmation by LC-MS/MS.

Responsible for installation and validation of new mass spectrometers and liquid chromatography systems.

Responsible for maintaining, troubleshooting, and operating the mass spectrometer systems.

Responsible for data interpretation generated from the LCMS confirmation assay, upload to the laboratory information system (LIS), and report generation for medical providers into the electronic medical records (EMR).

Responsible for maintenance and quality control on the AU400 immunoanalyzer.

Implemented and validated the laboratory information system for entering and reporting patient results.

Routinely performed proficiency testing, quality control, calibration, tuning, instrument troubleshooting, Levey-Jennings reports – and responsible for documentation to remain in compliance, including any corrective actions.

Wrote and established standard operating procedures for the laboratory.

Responsible for managing and training of laboratory technicians.

Scored 99% on my COLA laboratory survey (5/19/2015).

Established a new routine genetic testing laboratory within our clinic using single-nucleotide polymorphism (SNP) array for multiple pharmacogenetic targets in various therapeutic classes, but mainly focusing on pain management.

Performed analytical and clinical validation of sixty SNP qPCR assays utilizing OpenArray and two copy-number variation assays for CYP2D6 utilizing a 384-well assay format.

Proficient in high-throughput isolation of DNA from buccal swabs utilizing Applied Biosystems MagMAX Express-96 magnetic particle processor for sample preparation for drug metabolism enzyme (DME) genotyping analysis on OpenArray plates and copy number variation (CNV) analysis - as well as quantification using RNase P detection - in 384-well format (Applied Biosystems QuantStudio 12K Flex Real-Time PCR Systems).

Analyst II / Certifying Scientist, Hill Country Toxicology, San Antonio, Texas

August 2012 – April 2013

Clinical Operations Department:

Prepared human urine specimens by enzymatic hydrolysis for toxicological evaluation of patient samples.

Responsible for LC-MS/MS quantitation of over 70 analytes within our Pain Management analysis panel; including analyses, data processing and result interpretation required of the Clinical Laboratory Improvement Act (CLIA).

Normally operated, maintained, troubleshot, and performed methods development and refinement on Agilent 6410 Triple Quadrupole LC mass spectrometers with Agilent 1260 Infinity Binary LC and autosampler front ends.

Responsible for quality control review of the Olympus AU400 chemistry immunoanalyzer photometric data; and correlation with LC-MS/MS confirmation data.

Mass Spectrometry Scientist / Research Associate, Reata Pharmaceuticals, Irving, Texas

September 2011 – August 2012

Product Development, Drug Metabolism and Pharmacokinetics Group:

Performed routine bioanalysis of samples from preclinical studies utilizing Waters triple quadrupole and time-of-flight mass spectrometers (Xevo TQD, TQ-S, and QTof) and Acquity UPLC for Reata’s novel class of oral anti-inflammatory drugs; and responsible for establishing methodologies and analytical assays for these potential new drugs and their metabolites.

Sample preparation for these analyses includes homogenization techniques for various tissues and solid-phase or liquid-liquid extraction in a low-throughput format.

Performed microsomal incubations to study cytochrome P450 inhibition of specific isoforms and for studying the metabolic profiles of advanced compounds prior to investigational new drug (IND) submission.

Assessed maximum solubility limits of compounds in different cell culture media used in genotoxicity studies and other cell based assays using filtration and LC-MS/MS.

Determined stability of compounds in dosing formulations used in toxicity and pharmacokinetic studies in animals.

Senior Associate Scientist, Amgen Incorporated, Thousand Oaks, California

March 2003 – September 2011

Department of Pharmacokinetics and Drug Metabolism, Small Molecule Bioanalytical Group:

Developed rugged bioanalytical methods utilizing high throughput LC-MS/MS techniques (Tecan Genesis, Eppendorf epMotion, and Tomtec workstations with Sciex API -3000/4000/5000 analysis using Analyst Software) for small molecule drug candidates and peptide-based biopharmaceuticals in various biological matrices (including plasma and tissue/tumor homogenates) from various preclinical species.

Conducted LC-MS/MS assays in support of cancer, neuroscience, metabolic disorders, and inflammation discovery research, preclinical pharmacology, clinical pharmacokinetics (discovery support with 24 hour turnaround times), and toxicology under SOP and GLP compliance.

Responsible for pharmacokinetic data releases generated using non-compartmental analysis within the Watson laboratory information management system.

Accountable for distribution and presentation of data to project teams and project team status to the department.

Performed HPLC-APCI/ESI-MS/MS assay development and refinement, validation implementation, assay protocol and standard operating procedure preparation, as well as documentation summaries of analyses.

Routinely developed UHPLC methods utilizing reduced cycle times with ultra-high pressure pumps and solid/fused-core columns at controlled temperatures for same-day turn-around time for data release of samples received.

Maintained automation and analytical instrumentation under SOP and GLP compliance.

Performed computer related system installations and operational qualifications (IQ/OQ) for validating the operation of new mass spectrometers and peripherals using Analyst v1.3 and v1.4 under GLP compliance.

Senior Research Associate, Lexicon Pharmaceuticals Incorporated (formally Lexicon Genetics), The Woodlands, Texas

November 2001 - March 2003

Cardiology - In-Vivo ADME Group:

Responsible for project management and analytical method development and analysis by LC-MS/MS (Sciex API-3000) of samples generated from in-house murine pharmacokinetic and absorption studies of investigational new small molecules designed to inhibit Lexicon's in-vivo validated functional targets.

Optimized rapid throughput sample preparation.

Responsible for determination of compound solubility in dosing vehicles and the formulation of dosing solutions.

Developed assays for identification of potential metabolites from in-life studies.

Pharmaceutical Discovery - HTS Group:

Responsible for developing and validating enzymatic, receptor-ligand binding and metabolic high throughput screening (HTS) assays for implementation into automation (Biomek FX, 2000).

Responsible for developing screening assays on high throughput analytical instrumentation, including Tecan Ultra 384, Molecular Devices, and Packard Fusion plate readers for absorbance, fluorescence, and fluorescence polarization assays; and the Packard TopCount NXT for radioligand based assays.

Prepared assayable genomically derived proteins from yeast, bacterial, and mammalian cells.

Optimized the use of novel enzyme substrates and ligands of orphan receptors.

Became very adept in liposome and radiolabeled substrate preparation and fraction collection.

Performed low throughput screening and substrate purification using HPLC with various detection methods.

Research Associate II, Amgen Incorporated, Thousand Oaks, California

April 1999 - October 2001

Department of Pharmacokinetics and Drug Metabolism, in-vitro ADME Group:

Established the use of primary culture hepatocytes for use in cell-based bioassays at Amgen.

Responsible for equipping an existing laboratory for mammalian cell culture procedures.

Developed assays to determine the metabolic competence of isolated primary culture hepatocytes for use in in-vitro metabolism investigations and performed incubations to evaluate biotransformation kinetics.

Developed analytical methods for analysis of primary hepatocyte and microsomal incubations using the HPLC Waters Alliance system (with photo diode array and in-line radiometric detection: β-RAM flow scintillation analyzer), Micromass LCZ LC-MS, Sciex API-3000 LC-MS/MS, as well as liquid scintillation analysis.

Optimized sample preparation procedures including solid-phase, liquid-liquid extractions, and protein precipitation.

Developed and performed fluorescent high-throughput P450 inhibition assays with recombinant enzymes using a Spectramax plate reader with Softmax Pro software; and automated using the Tecan Genesis RSP 150 workstation.

Prepared microsomal and other subcellular fractions from whole livers and determined protein content, total cytochrome P450 concentration, and enzymatic activity using UV-VIS and LC-MS and prepared standard operating procedures and test methods for these assays.

Laboratory Associate, CEDRA Corporation, (Currently known as Worldwide Clinical Trials Drug Development Solutions) Austin, Texas

March 1996 - April 1999

In-vitro Drug Metabolism Division:

Performed microsomal incubation procedures for in-vitro assessment of cytochrome P450 enzyme kinetics.

Responsible for the operation and maintenance of the Micromass Quattro II LC-MS/MS for the analyses of in-vitro metabolism evaluations, and developed LC-MS/MS analytical methods for the assessment of specific P450 isoforms.

Validated and wrote standard operating procedures for these assays following stringent GLP guidelines.

Responsible for the technical review and reporting of data produced from inhibition studies of new chemical entities.

Bioanalytical Laboratory:

Conducted bioanalytical support for toxicology and pharmacokinetic studies by developing, validating, and performing assays for preclinical and clinical studies, using various techniques and high throughput methodologies.

Performed liquid-liquid extraction techniques and solid-phase extraction sample preparation procedures.

This position required a working knowledge of mass spectrometry, HPLC, spectrophotometry, as well as other laboratory instruments and computer programs.

Developed high throughput extraction and aliquotting methods using automation equipment, including Tomtec and Multiprobe workstations.

Responsible for the GLP validation of bioanalytical assays using manual and automated extraction techniques.

Performed immunoassays; including RIAs, ELISAs and chemiluminescent assays (using ORIGEN detection technology).

Used the Franz dissolution apparatus for studying permeability of topical preparations.

Responsible for writing standard operating procedures and final reports for these studies.

HepCyte Cell Culture Team:

Performed hepatocyte isolations from various species and prepared these primary isolations for culture kits.

Responsible for the culturing of these cells for metabolism studies.

Responsible for laboratory animal maintenance and upkeep.

Assisted in the upkeep of CACO-2 cells for absorption/permeability studies.

These cell culture procedures required knowledge of sterile technique and media preparation.

Quality Control Data Management Unit:

Responsible for processing raw bioanalytical data from various data acquisition systems.

Performed GLP QC checks on bioanalytical assay reports, data tables, and final assay validations and reports.

Others duties included GLP Quality Control/Quality Assurance of laboratory equipment which included daily inspections and monthly laboratory audits.

Laboratory Technician, US Army Corps of Engineers Waterways Experiment Station, Vicksburg, MS

June 1990 – Jan 1996

Hazardous Waste Research Center, Wetlands Research Program:

Conducted bench-scale column studies of adsorbents in attempt to remove industrial contaminants from water.

Evaluated contaminated soils and dredged material with various tests and performed solidification/stabilization treatments for these contaminated solids.

Responsible for final report preparation and data entry used for generation of tables and graphs.

Ecosystem Research and Development, Wetlands Research Program:

Conducted greenhouse tests pertaining to plant uptake of heavy metals and other pollutants to study plant bio-accumulation of contaminants (heavy metals, organics, explosives) for environmental impact assessments and phyto-remediation of contaminated soils.

Conducted environmental contaminant uptake studies on wetland-dependent plants and organisms.

Performed field collections of soils, dredged material, and waters for various studies including assessment of contaminant mobility in artillery impact areas.

Performed invertebrate bioassays and toxicity tests.

Prepared environmental samples from the field as well as those generated in-house for analysis of heavy metals and pesticide residues. This required knowledge of various digestion techniques of soil, animal, and plant material.

Other duties included report preparation, greenhouse maintenance, test animal upkeep, and various lab practices.

Contributed to studies resulting in miscellaneous papers approved for public release:

Agricultural Uses of Yazoo River Dredged Material. Report 1. Cotton Production on Dredged Material in a Thick-Layer Confined Disposal Facility. Accession Number: ADA268778, Report Date: JUL 1993

Evaluation of Upland Disposal of Richmond Harbor, California, Sediment from Santa Fe Channel. Accession Number: ADA269951, Report Date: JUL 1993

Evaluation of Upland Disposal of Oakland Harbor, California, Sediment. Volume 2: Inner and Outer Harbor Sediments. Accession Number: ADA272999, Report Date: AUG 1993

Field Survey of Contaminant Concentrations in Existing Wetlands in the San Francisco Bay Area. Accession Number: ADA385446, Report Date: NOV 2000

Evaluation of Wetland Creation with John F. Baldwin Ship Channel Sediment. Accession Number: ADA386004, Report Date: NOV 2000

Substitute Teacher, Hinds Community College, Vicksburg, Mississippi

Spring 1994, Freshman Biology

Substitute Teacher, Porters Chapel Academy, Vicksburg, Mississippi

Fall 1993, Junior-Senior Chemistry

Professional Membership:

American Society for Mass Spectrometry, 2004 – present

Education:

Mississippi College, Clinton, Mississippi - January 1991 - May 1995

Completed Bachelor of Science in Biological Science (3.3 GPA) with minors in Chemistry and Psychology

Graduate work toward a Master of Combined Science (Chemistry/Biology)

Mississippi State University, Mississippi State, Mississippi - August 1990 - December 1990

Work towards Bachelor of Science degree

Additional Training:

* Fundamentals of Laboratory Leadership (Clinical Laboratory Management Association, KnowledgeLab 2015)

* Agilent 6400 Series LC/MS Techniques and Operation (Course Number R1893, Agilent Technologies)

* Improving your QQQ LC/MS Uptime (Course Number R3935A, Agilent Technologies)

* Bioanalytical Method Validation and Sample Analysis: Challenges, Solutions, Applications, Global Industry Standards, and New Regulations Course (6th Workshop on Recent Issues in Bioanalysis, March 2012, San Antonio, TX)

* MassLynx 4.1, QuanLynx, MetaboLynx, and MassFragment Software Fundamentals Training Course from Waters

* Acuity UPLC TQD Operation and Maintenance Course (Waters Educational Services)

* Xevo Q-ToF Operation Training, Small Molecule Applications (Waters Educational Services)

* Xevo TQ-S Operation Training (Waters Educational Services)

* AB Sciex 5600 QTOF Analyst Operator Training

* Sciex API-2000/3000 Analyst Operator Training Course

* Sciex API-5000 (with Analyst 1.4) Operator Training Course

* Validation and Application of Bioanalytical Methods Used in Support of GLP Studies and Clinical Trials SOP Training

* Cecilia Basic’s “Instruments for Accurate Mass Analysis and Quantitative Applications” training course (June 2011)

* Good Laboratory Practice Regulations/Intro to GLPs and GLP Documentation

* Introduction to Pharmacokinetics

* Blood borne Pathogens Awareness Training (with yearly refresher classes)

* Radiation Safety Training for Users (with yearly refresher classes)

* Laboratory (Hazardous and Bio-) Waste Management and Hood Safety Awareness Training

* AALAS Animal Care and Use Training

* 21 CFR Part 11 for Clinical Development

* Comparison of OECD and MHW to FDA GLP Regulations

* Early Development/Medical Science Education

* Intra-functional education: Protein/Immunology, Oncology, Hematology, and Neuroscience therapeutic areas

* Regulatory Inspection Conduct Training

* Chemical Hygiene/Potent Compound/Hazard Communication Training

* Environmental Health and Safety Plan Training

* Laboratory Inspections Training

* Regulatory Affairs Education

* Information System Validation Training

* Microsoft Excel Advanced Functions

* Microsoft PowerPoint Embedding and Linking

Publications:

Han Xu, Michele McElvain, Mike Fiorino, Brad Henkle, Lisa Sherman, Yang Xu, Elizabeth Tominey, Keith Kelley, Matt Adlam, Roland Burli, Jerry Siu, Min Wong and Victor J. Cee. Predictability of Peripheral Lymphocyte Reduction of Novel S1P1 Agonists by In Vitro GPCR Signaling Profile Journal of Biomolecular Screening, 2013 Oct;18(9):997-1007.

Qingping Zeng, John G. Allen, Matthew P. Bourbeau, Xianghong Wang, Guomin Yao, Seifu Tadesse, James T. Rider, Chester C. Yuan, Fang-Tsao Hong, Matthew R. Lee, Shiwen Zhang, Julie A. Lofgren, Daniel J. Freeman, Suijin Yang, Chun Li, Elizabeth Tominey, Xin Huang, Douglas Hoffman, Harvey K. Yamane, Christopher Fotsch, et al. Azole-based inhibitors of AKT/PKB for the treatment of cancer Bioorganic & Medicinal Chemistry Letters, Volume 20, Issue 5, 1 March 2010, Pages 1559-1564

Qingping Zeng, Matthew P. Bourbeau, G. Erich Wohlhieter, Guomin Yao, Holger Monenschein, James T. Rider, Matthew R. Lee, Shiwen Zhang, Julie Lofgren, Daniel Freeman, Chun Li, Elizabeth Tominey, Xin Huang, Douglas Hoffman, Harvey Yamane, Andrew S. Tasker, Celia Dominguez, Vellarkad N. Viswanadhan, Randall Hungate, Xiaoling Zhang. 2-Aminothiadiazole inhibitors of AKT1 as potential cancer therapeutics Bioorganic & Medicinal Chemistry Letters, Volume 20, Issue 5, 1 March 2010, Pages 1652-1656

Averett, D.E.; Zappi, P.A.; Tatem, H.E.; Gibson, A.C.; Tominey, E.A.; Tate, N.S.; Graham, S.L.; Kenna, B.T.; Yaksich, S.M. 1996. Buffalo River Dredging Demonstration. Prepared by U.S. Army Engineer Waterways Experiment Station and Buffalo District, U.S. Army Corps of Engineers. Technical Report EL-96-2.

Posters: (for external presentation)

Anna Akrami; Shubhada Kulkarni; Elizabeth Williams; Craig Marshall; Beth Tominey; Bernd Bruenner; Keyang Xu; John Laycock; Julie Flynn; Krys Miller. (Amgen Inc., Thousand Oaks, CA) The Development of a 1.00 pg/ml Robust Analytical Procedure to Support Microdosing Studies. (2004 ASMS Annual Conference on Mass Spectrometry)

Sajeevi Gunasekera, Craig Marshall, Beth Tominey, and Paul Burke. (Amgen Inc., Thousand Oaks, CA) Bradykinin (B1) Peptide Antagonist Acylation in Poly(lactide-co-glycolide) (PLG) Microspheres. (Presented at Pepperdine University, October 2004)

Contact this candidate