resume - michael freund

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MICHAEL J. FREUND 4345 Wisconsin Ave, NW Washington, D.C. 20016 (703) 887-8717 [email protected] EXPERIENCE: BioReliance, Rockville, Maryland Senior Associate Scientist: Virology Services – Retrovirology Department, September 2012 - Present. Study Director and lead scientist for routing and custom GLP/cGMP studies performed in the retrovirology department, assuring that all applicable regulations are followed. Responsible for the scientific and technical conduct of retroviral safety testing. Generate and approve protocol/study plan and ensure that applicable governing test procedures are followed. Oversee the collection, interpretation, analysis, documentation and reporting of study results. Compile, evaluate, and review assay results and generate or assist in the generation of the final report. Identify circumstances which may affect study integrity and assure that appropriate corrective actions are taken and documented. Interact with clients to recommend appropriate testing protocols per regulatory guidelines and recommendations based on the nature and origin of the test sample. Validate existing assay methodology in support of offering additional cGMP testing procedures. Develop custom and new assay protocols and procedures to meet the individual needs of study sponsors. Train new employees and ensure staff is adequately trained/retrained to perform GLP/cGMP testing. BioReliance, Rockville, Maryland Laboratory Supervisor and Senior Laboratory Supervisor: Retrovirology and Reverse Transcriptase Laboratories, August 2004 - September 2012. Page 1 of 2

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Page 1: Resume - Michael Freund

MICHAEL J. FREUND4345 Wisconsin Ave, NWWashington, D.C. 20016

(703) 887-8717 [email protected]

EXPERIENCE:

BioReliance, Rockville, MarylandSenior Associate Scientist: Virology Services – Retrovirology Department, September 2012 - Present.

Study Director and lead scientist for routing and custom GLP/cGMP studies performed in the retrovirology department, assuring that all applicable regulations are followed.

Responsible for the scientific and technical conduct of retroviral safety testing.

Generate and approve protocol/study plan and ensure that applicable governing test procedures are followed.

Oversee the collection, interpretation, analysis, documentation and reporting of study results.

Compile, evaluate, and review assay results and generate or assist in the generation of the final report.

Identify circumstances which may affect study integrity and assure that appropriate corrective actions are taken and documented.

Interact with clients to recommend appropriate testing protocols per regulatory guidelines and recommendations based on the nature and origin of the test sample.

Validate existing assay methodology in support of offering additional cGMP testing procedures.

Develop custom and new assay protocols and procedures to meet the individual needs of study sponsors.

Train new employees and ensure staff is adequately trained/retrained to perform GLP/cGMP testing.

BioReliance, Rockville, MarylandLaboratory Supervisor and Senior Laboratory Supervisor: Retrovirology and Reverse Transcriptase Laboratories, August 2004 - September 2012.

Managed employees to ensure that all testing was scheduled and performed out according to GLP/cGMP standards and prescribed timelines.

Assisted in development and qualification of new procedures tailored to meet the unique specifications clients required.

Compiled, evaluated, and reviewed assay data for reporting results.

Developed, reviewed, and revised standard operating procedures.

Trained new employees.

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Page 2: Resume - Michael Freund

BioReliance, Rockville, MarylandMember of Technical Staff I and II: Retrovirology and Reverse Transcriptase LaboratoriesSeptember 2000 - August 2004.

Characterized product or material safety using GLP compliant procedures to perform a wide variety of assays, primarily involving mammalian cell culture, to test client samples for the presence of retroviruses.

Made scientific observations regarding health of cell cultures and maintained detailed workbooks according to GLP requirements.

Scheduled and performed testing of client samples to detect reverse transcriptase and/or DNA polymerase using radioactivity based RT assay.

Identified and recommended improvements that increased efficiency and effectiveness of work processes.

Prepared media and solutions consistent with consumption patterns and shelf life specifications.

Maintained and calibrated laboratory equipment.

Identified and ordered supplies needed for all aspects of laboratory work.

EDUCATION:University of Wisconsin, Madison, WisconsinBachelor of Science, Zoology, May 2000

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