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Information Science Fellowship - FDA CDER

Company: Non Specific Employer
Location: Silver Spring
Posted on: May 17, 2019

Job Description:

Education - Bachelor's Degree - Doctoral Degree - Master's Degree Skills - .NET - Computer Skills - Visual Studio - HTML5 - C/C++ Benefits - Health Insurance Organization U.S. Food and Drug Administration (FDA) Reference Code FDA-CDER-2018-0304 How to A complete application consists of: An application Transcripts - Click here for detailed information about acceptable transcripts A current resume/CV, including academic history, employment history, relevant experiences, and publication list Two educational or professional references All documents must be in English or include an official English translation. If you have questions, send an email to ***************. Please include the reference code for this opportunity in your email. Description A research opportunity is currently available in the Office of Pharmaceutical Quality (OPQ) Immediate Office at the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA). This project resses one of the main challenges in regulation of new, biologic, and generic drugs: the establishment of adequate quality standards. The project will identify critical attributes of drug substance and formulation, critical process parameters and their interactions, development of control strategies. The incumbent will have a hands-on learning opportunity to computer programming knowledge (e.g. HTML, CSS, JavaScript, C++, Microsoft Visual **********) and data analysis within the scope of the project. Comprehensive product and process understanding of drug products are warranted; improved understanding will support guidance and policy development needed for ensuring high quality of drugs across their life cycles. Upon the findings, reviewers in CDER will have a better understanding of what might be the most appropriate quality standards for drug products. Under the guidance of a mentor, the participant will be trained in: conducting a data search in literature and FDA databases to collect quality data on a number of drug products; identifying a series of critical quality attributes; developing test procedures and acceptance criteria based on these attributes; identifying critical formulation and manufacturing process variables affecting the quality of drug products; establishing quality standards to facilitate product development, manufacture, and review of drug products. This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for one year, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits. The Homeland Security Presidential Directive-12 (HSPD-12) mandates a background check be completed for both U.S. Citizens and foreign nationals. Foreign nationals must have resided in the U.S. for at least three (3) of the past five (5) years in order for FDA to be able to complete a background check. Qualifications Bachelor's or higher in computer science or a closely related computational or information science field earned within five years of the desired start date required. Background in computer programming (e.g. HTML, CSS, JavaScript, C++, Microsoft Visual studio .NET) is desired. Eligibility Requirements Degree: Bachelor's Degree, Master's Degree, or Doctoral Degree received within the last 60 month(s). Discipline(s): Computer Sciences (17 ) Engineering (2 ) Life Health and Medical Sciences (47 ) Mathematics and Statistics (11 )

Keywords: Non Specific Employer, Silver Spring , Information Science Fellowship - FDA CDER, Other , Silver Spring, Maryland

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