Debra I. Rhyne

**** ******** ***** ( RALEIGH, NC 27614

919-***-**** ( acf62t@r.postjobfree.com ( www.linkedin.com/debrarhyne

Clinical Laboratory Scientist

PHARMACEUTICAL RESEARCH AND DEVELOPMENT ( CLINICAL LABORATORY MEDICINE (

ASCP CERTIFIED

ACCOMPLISHED PROFESSIONAL WITH SIGNIFICANT EXPERIENCE IN CLINICAL

LABORATORY MEDICINE AND PHARMACEUTICAL RESEARCH AND DEVELOPMENT, SUPPORTING

GLP TOXICOLOGY STUDIES INVOLVING DATA ANALYSIS, ENTRY, REVIEW, AND

MANAGEMENT. SOLID BACKGROUND IN LABORATORY MEDICINE AND KNOWLEDGEABLE IN

MEDICAL TERMINOLOGY, GOOD LABORATORY PRACTICES (GLPS) AND FOOD AND DRUG

ADMINISTRATION REGULATIONS. PROFICIENT IN NORMAL AND ABNORMAL DATA

COLLECTION AND REPORTING, METHOD DEVELOPMENT PROTOCOL WRITING AND

REPORTING, AND STANDARD OPERATING PROCEDURE (SOP) DEVELOPMENT. EXCELLENT

COMMUNICATION, COMPUTER, AND ORGANIZATIONAL SKILLS. STRONG INITIATIVE AND

EQUALLY ADEPT AUTONOMOUSLY OR WITHIN A TEAM. PROFESSIONAL CERTIFICATIONS

IN MEDICAL TECHNOLOGY, MLT (ASCP), MT (HHS) AND MEMBERSHIP IN AMERICAN

SOCIETY OF CLINICAL PATHOLOGISTS (ASCP).

CAP Proficiency Surveys Quality Control

SOP development Statistical Analysis

Hematology qPCR (ABI 7900)

Chemistry Gene Expression Profiling

Urinalysis Computer Validation

Professional Experience

Liposcience, Inc- Raleigh, NC

2012 to 2014

NMR MEDICAL TECHNOLOGIST

PERFORMED LIPOPROTEIN ANALYSIS ON HUMAN SERUM SAMPLES USING THE NMR

PROFILER AND THE VANTERA CLINICAL ANALYZER IN A CLIA-REGULATED LABORATORY.

THE NMR LIPOPROFILE TEST IS THE ONLY FDA-APPROVED ASSAY FOR LIPID PARTICLE

ANALYSIS BY NUCLEAR MAGNETIC RESONANCE (NMR). IN THE BEGINNING OF MY

EXPERIENCE AT LIPOSCIENCE, I ANALYZED 700 SAMPLES PER NIGHT ON TWO VANTERA

CLINICAL ANALYZERS. BY EARLY 2014, I WAS ANALYZING 1200 SAMPLES ON FOUR

VANTERA CLINICAL ANALYZERS.

ORANGE COUNTY PUBLIC SCHOOLS- HILLSBOROUGH, NC

2010 TO 2011

HEALTH OCCUPATIONS TEACHER

TAUGHT HEALTH OCCUPATIONS COURSES (HEALTH TEAM RELATIONS, BIOMEDICAL

TECHNOLOGY, ALLIED HEALTH I) TO HIGH SCHOOL STUDENTS AT CEDAR RIDGE HIGH

SCHOOL. TAUGHT FIRST INTRODUCTION TO BIOTECHNOLOGY TO STUDENTS AT ORANGE

HIGH SCHOOL.

WAKE COUNTY PUBLIC SCHOOLS- WENDELL, NC

2009 TO 2010

HEALTH OCCUPATIONS TEACHER

TAUGHT HEALTH OCCUPATIONS COURSES (HEALTH TEAM RELATIONS, BIOMEDICAL

TECHNOLOGY, MEDICAL SCIENCE I) TO HIGH SCHOOL STUDENTS AT EAST WAKE SCHOOL

OF HEALTH SCIENCE. PARTICIPATED IN DATA TEAM FOR OUR PROFESSIONAL LEARNING

COMMUNITY (PLC).

GLAXOSMITHKLINE, INC. - RESEARCH TRIANGLE PARK, NC 1992 TO 2009

SENIOR SCIENTIST (2005 TO 2009)

Scientist (2002 to 2005)

Clinical Pathology Scientist (1996 to 2000) (2001 to 2002)

Clinical Pathology Technologist II (1992 to 1995)

Analyzed biological samples to support preclinical GLP toxicology studies

in Safety Assessment. Made technical decisions and observations to support

the interpretation of data. Collected and reviewed data in LIS (Provantis(

7, Provantis( 6,TOX1, Worksheet Manager for reporting. Assimilated and

reported clinical pathology study data to support preclinical submissions

to the FDA. Authored and updated SOPs (Standard Operating Procedures), and

conducted scientific validations on new biomarkers and instrumentation.

Served as lead scientist in gene expression, hematology, and chemistry

laboratories. Evaluated quality control and adjusted control ranges based

upon statistical analysis.

. Selected to bring gene expression profiling technology to GSK RTP Safety

Assessment, implement a harmonized process for liver tissue evaluation on

candidate selection studies, and maintain all instrumentation, resulting

in novel and highly useful data for recognizing mechanisms of liver

toxicity and pathology associated with specific classes of compounds. In

2007, process improvements yielded twice as many studies in 33% less time.

. Managed the proficiency survey process that supported the integrity of

GSK RTP SA study analysis in the event of an FDA inspection (College of

American Pathologists, Veterinary Laboratory Association).

. Received Bronze Award from a project team for 3-year lipid analysis lab

support of the chemical development of a compound.

. Identified dose-response by calculating fold-changes of clinical

pathology measurements on study tables for treated groups against control

for purpose of interpretation.

. Facilitated transfer of IT support offshore by serving as lead user for

gene expression project, reviewing and editing user's manual, and co-

writing project specifications.

. Authored method development protocols and reports to meet GLP

requirements for addition of new instrumentation or biomarkers to improve

or expand laboratory capabilities.

. Initiated own cross training in Clinical Pharmacology and Safety

Assessment to learn role of Clinical Research Scientist and SA Study

Director.

. Scheduled and moderated world wide teleconferences with global team

involved in gene expression to address problems and make improvements

related to gene expression analysis, harmonizing processes across all

sites and improving and shortening analysis time on gene expression from 6

to 4 days.

. Interacted with GSK Preclinical Compliance on GLP studies, addressed and

documented QA findings on toxicology studies, ensuring all aspects of data

analysis and reporting followed protocol, SOPs, and GLPs in preparation

for FDA review or inspection.

. Performed scientific and computer validation of IRIS( Aution Max AX-4280

to satisfy GLPs and assess functionality for analytical use.

. Published and presented the Comparison of Urine Glucose Measurements from

the IRIS( Aution Max and Yellow IRIS (Semi-quantitative methods) and the

Hitachi 911 and the Olympus poster at the 2005 American College of

Veterinary Pathologists/American College of Veterinary Clinical

Pathologists meeting.

. Presented Using Advia( 120 Morphology to Detect Abnormalities in Sprague-

Dawley Rats at the 2004 Bayer Multi-species Users' Meeting.

. Developed new biomarkers and instrumentation in role of lead scientist in

clinical chemistry laboratory (1993-2002). Increased capability by

decreasing sample size and analysis time, adding approximately 25 assays

(or upgrades) to support toxicology studies.

American Medical Laboratories - Raleigh, NC and Fairfax, VA 1986 to 1992

Senior Medical Technologist (1987 to 1992)

Analyzed human biological samples (hematology, coagulation, chemistry, and

microbiology) for a satellite reference laboratory. Assisted with data

entry of sample requisitions. Provided technical assistance to clients.

. Managed laboratory during supervisor's absence providing back-up

management.

. Facilitated problem solving by liaising between the Raleigh lab and the

Fairfax lab.

Medical Lab Technician, Toxicology Laboratory (1986 to 1987)

Analyzed over 200 human biological samples daily to assess presence of

drugs of abuse, special chemistries.

. Compared and developed two lab procedures for LSD (HPLC and RIA) in

support of a clinical chemist.

Additional Experience

Served as a Medical Lab Technician for physician groups and hospitals in

North Carolina and Virginia.

Education & Training

Bachelors of Science in Health Occupations Teacher Education (GPA 3.9)

(2000)

General Toxicology (2000) and Metabolism and Molecular Biology (2001)

North Carolina State University - Raleigh, NC

Associate of Applied Science in Medical Laboratory Technology (GPA 3.9)

Western Piedmont Community College - Morganton, NC

Major: Medical Technology

University of North Carolina at Chapel Hill- Chapel Hill, NC

Technical Proficiencies

Microsoft( Office 2007 for Macintosh and PC (Word, Excel, PowerPoint,

Outlook Mail), Microsoft(Windows XP and 2000 operating systems, Lotus

Notes, Adobe Photoshop( Elements v6.0 for Macintosh, Internet Explorer

v7.0, Instem Provantis( 7 Laboratory Information System, Safari v3.2.1,

Mac OS X v 10.6.8 operating system

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