CURRICULUM VITAE

MICHAEL "STEVE" PICKETT

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___________________

Address: **** ***** ****** **** *-mail:

abgfli@r.postjobfree.com

Burlington, NC 27215 Phone: 336-266-

8371

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Education

Degree

Institution Date

Bachelor of Science Winston Salem State University

August 2006

Clinical Laboratory Science Winston Salem NC

School of Dentistry University of NC at Chapel Hill

September 1989-May 1991

Chapel Hill NC

Bachelor of Science Elon University May

1988

Biology Elon NC

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Work History

Position Company

Date

Clinical Lab Director High Point Clinical Trials Center

Dec. 2008 - February 2012

High Point NC

Laboratory Manager Laboratory Corporation of America

June 2002 - February 2009

Burlington NC

Sales Director Victory K-9 Training Inc.

1995 - 2002

Burlington NC

Supervisor Genetic Design Inc.

1992 - 1995

Greensboro NC

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QUALIFICATIONS SUMMARY

. Seasoned Clinical, Reference and Hospital Laboratory Leader, and Sales

Professional. Bringing you over 20 years in sales, laboratory, and

leadership experience.

. A Football Academic All-American who understands Teamwork, Leadership

and Motivation.

. Scientifically Oriented with a strong background in quantitative

analytical skills.

. Hands on Manager responsible for the technical and scientific aspects

in both a High Complexity Reference Laboratory and a Clinical Research

Facility.

. Started two moderate complexity GLP laboratories for a Phase I

Clinical Research facility.

. Liaison with pharmaceutical sponsors providing insight into clinical

laboratory tests for product protocols.

. Responsible for the selection of test methodology appropriate for

clinical use and test results.

. Established a quality control program appropriate for the testing

performed and establishing parameters for acceptable levels of

analytical performance.

. Development of a specimen tracking system that resulted in a drop of

lost specimens from 5% to <0.03%.

. Arranged work flow within the accessioning department to increase

productivity by 2 hours and reduce overtime by 90%.

. Successfully accomplished high personal and professional goals.

Attended second-degree program full time, with an overall GPA of 3.93,

while achieving exceptional quality control and productivity goals

managing a high complexity laboratory full time.

PROFESSIONAL EXPERIENCE

Clinical Laboratory Director

Apr. 2012- present

Yadkin Valley Community Hospital

Yadkinville, NC

. Manage a team of Medical Technologist in the daily operations of a

high complexity hospital clinical laboratory. To include the receiving

of the specimens, performing the required testing accurately and a

timely manner and results are reported out in a timely manner.

. Maintain accreditation of the laboratory through CLIA, COLA and JCHCO,

ensuring all work is in accordance with state and federal regulations,

organizational policies and compliance requirements.

. Ensure testing systems developed and used for each of the tests

performed in the laboratory provide quality laboratory services for

all aspects of test performance, which includes pre-analytic,

analytic, and post-analytic testing phases.

. Analyze data for accuracy and verify any questionable results and or

documentation errors. Thoroughly investigating these findings and

following through with the appropriate action.

. Conduct new method and equipment evaluation, ensuring the methods and

instrumentation meets all accreditating requirements for testing.

. Established method development and analytical analysis for the

hospitals clinical laboratory.

. Evaluated and created a complete test menu that ensures the laboratory

is efficient and cost effective.

. Established and maintained a proficiency testing program to identify

any performance problems not recognized by internal mechanisms.

. Established and maintained a calibration verification program to

validate the continued accuracy of our testing system.

. Prepared and managed laboratory budget, including equipment

acquisition, purchasing and inventory control.

. Ensure quality control and quality assessment programs are established

and maintained. Assess the quality of laboratory services provided and

identify failures in quality as they occur.

. Maintained compliance and quality control guidelines to ensure the

integrity of laboratory specimens and accuracy of results.

. Rewrote most of the hospital laboratory policies to match all current

methodologies.

Clinical Laboratory Director

Dec. 2008 -Feb. 2012

High Point Clinical Trials Center

High Point, NC

. Responsible for Hands On Operation and Administration of Phase I

Clinical Research Laboratory. Hiring of competent personnel to

perform test procedures. Perform, record and report test results

promptly and accurately, assure quality control and compliance with

applicable regulations.

. Ensure testing systems developed and used for each of the tests

performed in the laboratory provide quality laboratory services for

all aspects of test performance, which includes pre-analytic,

analytic, and post-analytic testing phases.

. Small molecule analysis using LC/MS/MS and HPLC instrumentation.

. Established method development and analytical analysis for clinical

laboratory.

. Cost Analysis, Contract Negotiations, Budget, Equipment Acquisition,

Purchasing and inventory control for establishing two clinical

laboratories and maintaining facilities.

. QA/QC Coordinator for the facility. Conducted internal audits of all

departments. Compiled detailed reports of any violations with

recommendations for corrections. Conducted protocol audits for

pharmaceutical sponsors ensuring clinical compliance with ICH and GCP

standards.

. Ensure quality control and quality assessment programs are established

and maintained. Assess the quality of laboratory services provided and

identify failures in quality as they occur.

. Coordinate with Institutional Review Board (IRB) for protocol review

and approval.

. Facilities Manager responsible for validation, calibration and

maintenance of all equipment; all ECG's, vitals, analyzers,

refrigerators, freezers, hoods, and temperature monitoring systems.

. Analyze data locating trends related to the investigational drug.

Collaborate with Study Manager and/or Principle Investigator to ensure

data is complete and correct.

. Developed and maintained all laboratory SOP's. This includes

establishing all policies and procedures for monitoring personnel who

conduct pre-analytical, analytical and post-analytical phases of

testing.

. Maintained compliance guidelines for GLP Lab, to include CFR 21 part

11.

. Safety Director for facility, 120 employees, contractors and clinical

trial subjects.

. Wrote all plans and SOP's to OSHA specifications and Conducted

Facility Safety Training on Blood born Pathogens, Exposure Control,

Chemical Hygiene and Hazard, Emergency Response Plan, Disaster

Recovery Plan, Bio-hazard Waste Management, and Emergency

Communication. This includes writing all necessary forms, teaching all

new and ongoing safety training.

. CLIA Laboratory Director certification.

Laboratory Manager

Laboratory Corporation of America (Lab Corp)

2002 - February 2009

Burlington NC

. Managed and worked hands on along side a 26-person staff in a high

complexity laboratory. Conducted quarterly and annual performance

evaluations, weekly scheduling, department meetings, education and

training, conflict resolution and motivation.

. Handled Quality Assurance and Control of reagents, media and parallel

testing in the lab.

. Liaison between doctors and hospitals answering result and test

questions, as well as, specimen type, collection methods, testing

specifications and transport requirements.

. Strong knowledge of cGMP and cGLP including ICH guidelines. Conducted

internal lab audits.

. Working laboratory knowledge in maintaining, performing

troubleshooting, and reviewing results by fatty acid extraction and

vitek 2 system for microorganism identification and susceptibility.

. Extensive work using HPLC, LC/MS/MS, and GC/MS instrumentation.

. Working laboratory experience in DNA and RNA amplification,

extraction, quantification and detection. ELISA, PCR and real time

PCR. Gel electrophoresis, to include SDS-PAGE, Isoelectric focusing,

Southern and Western Blotting.

. Extensive working knowledge in Microbiology and Chemistry.

. Participated in internal audits for clinical trails before final

review by the FDA.

. Conducted final review for departmental clinical studies, final

patient reports and quality control.

. Conducted test validation studies for molecular based and enzyme based

assays.

. Surpassed department goal for turn around time. Initiated new testing

which improved efficiency and accuracy.

. Introduced a Human Performance Program which reduced employee errors

by increasing communication and initiating peer check.

. Trained management at various company locations on computerization of

the lab, arranging work flow and specimen processing to increase

productivity and reduce employee errors, overtime, and lost specimens.

Sales Director

Victory K-9 Training Inc.

1995 - 2002

Burlington NC

. Managed sales force and acting consultant between Law Enforcement and

company.

. Closely worked with municipalities, Chief of Police, City Managers,

Law Enforcement Agencies.

. Developed and implemented sales protocol for production, sales, and

marketing of protection, narcotic, and explosive detecting canines.

. Established follow up procedures to maintain client relationships and

product performance.

. Negotiated transactions, terms, conditions and implementation of

contracts.

. Conducted comparative analysis and sales proposals to make specific

recommendations to clients.

. Managed business development, client prospecting, preparation and

delivery of marketing presentations.

. Organized and instructed canine handling schools. Trained protection,

narcotic, and explosive canines.

Supervisor

Genetic Design, Inc.

1992 - 1995

Greensboro NC

. Worked along side and Managed a 7-person laboratory, supervising team

members and evaluating progress to ensure that projects were planned

and performed within established time frames and met appropriate

standards.

. Responsible for radioactive probes for labeling extracted DNA for

paternity and forensic testing.

. Labeled extracted DNA, hybridized, radiographed and interpretation of

radiographs.

. Conducted quarterly and annual reviews, weekly scheduling, and

department meetings.

. Maintained laboratory inventory. Developed and monitored the making of

all radioactive probes.

. Created formal and informal reports for key client personnel and

project managers that included risks and recommendations for issues

identified during reviews.

Additional Information

Laboratory Instrumentation Proficiency

. LIMS (Laboratory Information Management Systems)

Orchard - Harvest

Accelerated Technology - Sample Master

. Chemistry Analyzer

Siemens Xpand

Hitachi 717

. Hematology

ADVIA 120

. Coagulation

Sysmex CA540 Coagulation Analyzer

. Urinalysis

Siemens Clintek Advantus Analyzer

. PCR (Polymerase Chain Reaction)

Applied Bio Systems - ABI 7500 Fast

Roche - Light Cycler 480

BIO Rad - Myi Q

. HPLC (High Performance Liquid Chromatography)

Shimadzu Prominence UFLCXR

. LC/MS/MS System (Liquid Chromatography/Mass Spectrometry)

AB Sciex API 5000

. GC/MS (Gas Chromatography/Mass Spectrometry)

Agilent 5973 Turbo

Certifications

CLIA Laboratory Director Certification (Clinical Laboratory Improvement

Amendment)

CITI GCP Certification (Collaborative Institutional Training Initiative)

(Good Clinical Practices)

Basic Concepts of Validation Certification

ACLS Certified (Advanced Cardiovascular Lifesaving)

IATA Certified (International Aviation Transportation Association)

Educational Honors and Awards

Winston Salem State University:

. Dean's List (GPA 3.93)

. Dean's Achievement Award Highest GPA School of Health Sciences

Graduate Class

. Outstanding Student Clinical Laboratory Science

. 2006 Class President

. Grades Committee for School of Nursing

Elon University:

. Dean's List (GPA 3.32)

. Beta Beta Beta Honor Society

. Outstanding Biology Student

. S. S. Red Wilson Athletic Scholarship

. Academic All-American Football

. Football and Track Four Year Letterman

. Superior ROTC Cadet, 4 years

UNC School of Dentistry:

. Dean's List (GPA 3.80)

. Vice President Class of 1993

. Academic Scholarship

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