Customer Service Quality Control

Soheila Girakhoo, Ph.D.

*** ******** *** ****, ** 10012

E-mail: *********@*****.***

Phone: 571-***-****

OBJECTIVE: Team player and experienced Microbiologist/Virologist/Laboratorian/Immunologist Have held senior roles working and teaching basic and advanced laboratory techniques, participating and leading advanced research endeavors in FDA, and have also had considerable regulatory experience in the private sector (that included lead roles on clinical and biologic applications).

SKILLS SUMMARY OF QUALIFICATIONS:

• Perform research data loading including support of different software for compilation and analysis of scientific data, e.g.: SMARTS, ENTERPRISE, AdEERS, MEDRA Code, and RABITS

• Interact with data management personnel to compile and integrate clinical trials data

• Analysis and modification of the research laboratory and investigational plans

• Accomplished professional writers. Wrote Annual Reports and regulatory documents to be submitted to the FDA. All documents were written according to guidelines contained in the Code of Federal Regulations (CFR)

• Comprehensive review of both preclinical and clinical research studies

• Online searches of published literature to remain abreast of current developments pertaining to the anti-tumor agents contained in portfolio

• Reviewing the Investigational New Drug (IND) applications

• Providing protocol Solicitation announcements for clinical trails that solicit the scientific community for clinical trails to investigate new anti-cancer agents for IND application.

• Ability to successfully handle meeting scheduling, coordination, and planning

• Ability to Compile and analyze results to assess the safety and effectiveness of drug development

• Knowledge of Regulatory Affairs, Compliance, Quality Control or Quality Assurance

• Knowledge of US and international regulations and biologics products

• Strong background in research to use emerging technology

• Multiple publications and presentations to peer reviewed audiences.

EMPLOYMENT HISTORY:

Salon Centric: A subsidiary of L’OREAL 2007- 2012

• Manager of sale products

• Customer Service

• Training and consultation

Technical Resources International, Inc. Bethesda, MD September 2005- June 2007

• Annual Reports submission to the FDA.

• Clinical trial design and consistency of treatment schedules.

• Adverse events, efficacy, and statistical analysis of data.

• Reviewing Investigational New Drug (IND) applications

• Quality control prior to submission.

• Team training meetings focusing on the Fundamentals of U.S. Regulatory Affairs.

Acambis Inc. Cambridge, MA. April 2001-June 2003

• Creation of novel life recombinant flavivirus vaccines,

• Characterization of new ChimeriVax vaccine candidates,

• Development of a new cell culture based smallpox vaccine,

• Worked on team that conducted clinical trials of vaccines to assess safety, tolerability and immunogenicity of viruses,

• Analysis of cellular RNA,

• DNA transfections,

• Immunoassays: Antibody detection,

• Immino-Histochemical staining,

• Flow Cytometry (FACS).

CBER-FDA Bethesda, MD December 1998- January 2001

• Study of the role of NS1 protein of the Dengue virus in the virus life cycle

• Generation of a monkey kidney cell line

• Determination of the mechanisms of different chemicals for NS1 protein enhancing viral growth

• Amplification and purification of DENGUE viruses

• Analysis of virus proteins

• Purification and expedition of human cell populations.

Medical school, University of Vienna/Austria 1983-1989

Extensive academic and research training in the following Departments:

• Microbiology and Laboratory Sciences

• Virology

• Immunology

• Oncology

• Dermatology

• Pediatric

• Allergy

EDUCATION:

PH.D. BIOLOGY AND GENETIC

(CONCENTRATIONS: VIROLOGY, IMMUNOLOGY, MICROBIOLOGY). UNIVERSITY OF VIENNA, AUSTRIA

PROFESSIONAL ASSOCIATIONS:

American Society of Tropical Medicine

American Society of Virology

TECHNICAL/COMPUTER SKILLS

• MS Office 2007, MS Word, Excel, Access, Oracle, PowerPoint, Adobe Acrobat

LANGUAGES

English, German, Farsi (Persian).

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