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FDA Studies on Thrombogenicity and Potency Assays

Company: Non Specific Employer
Location: Silver Spring
Posted on: November 7, 2019

Job Description:

Education - Bachelor's Degree - Doctoral Degree - Master's Degree Skills - Biochemistry - Western Blot - FDA Regulations Benefits - Health Insurance Organization U.S. Food and Drug Administration (FDA) Reference Code FDA-CBER-2019-0042 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 One educational or professional recommendation. Your application will be considered incomplete, and will not be reviewed until one recommendation is submitted. 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. Application Deadline 12/2/2019 3:00:00 PM Eastern Time Zone Description - Applications will be reviewed on a rolling-basis. A research opportunity is available in the Office of Tissues and Advanced Therapies (OTAT) at the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA) located in Silver Spring, Maryland. This project will focus on investigating the discrepancies in assignment of coagulation factor product potencies by different assay systems. Under the guidance of a mentor, the selected participant will conduct experiments on human and mouse blood plasma supplemented with coagulation factor proteins to investigate the mechanisms of coagulation drug action. The experiments will include enzymatic and clotting hemostasis assays and Western Blot analyses. Mouse models may be used to study drug pharmacokinetics and pharmacodynamics. The participant will receive mentoring on fulfilling the project, which will also include collaboration with investigators within and external to the FDA. Learning objectives will include training in design of experiments, preparation of scientific manuscripts and reports, presentation of data at scientific meetings, analytical assay development, and application of traditional and investigational clinical laboratory assays. Based on the participant's efforts on the project and subject to availability of funding, this 6-month appointment may be further extended annually, up to five years total. 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 six months, 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. Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years. FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency. This agreement covers such topics as the following: Non-employee nature of the ORISE appointment; Prohibition on ORISE Fellows performing inherently governmental functions; Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship; The fact that research materials and laboratory notebooks are the property of the FDA; ORISE fellow's obligation to protect and not to further disclose or use non-public information. Qualifications The qualified candidate should be currently pursuing or have received a bachelor's, master's or doctoral degree in one of the relevant fields. Degree must have been received within five years of the appointment start date. Preferred skills: Background in laboratory science in biochemistry and/or biophysics fields Experience with at least one of the following: hemostasis and thrombosis, protein purification, enzymology, clinical laboratory assays, mouse models of disease, or gene therapy Eligibility Requirements Citizenship: LPR or U.S. Citizen Degree: Bachelor's Degree, Master's Degree, or Doctoral Degree received within the last 60 months or currently pursuing. Discipline(s): Life Health and Medical Sciences (15 ) Other Physical Sciences (1 )

Keywords: Non Specific Employer, Silver Spring , FDA Studies on Thrombogenicity and Potency Assays, Other , Silver Spring, Maryland

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