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  1. Center for Biologics Evaluation and Research (CBER)

Staff Fellow/Visiting Associate: Scientific Reviewer

OFFICE OF BLOOD RESEARCH AND REVIEW (OBRR)
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER)
FOOD AND DRUG ADMINISTRATION (FDA)
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR), Division of Blood Components & Devices (DBCD) is recruiting to fill a Staff Fellow/Visiting Associate position in the Devices Review Branch (DRB).

The Office of Blood Research and Review regulates the manufacture and approval of blood products, related drugs and medical devices and retroviral diagnostic assays, conducts research on new scientific tools and procedures to enhance knowledge of blood borne diseases and blood product safety; develops policies on blood product standards, and conducts pre-license or pre-approval or surveillance inspections of blood establishments and other manufacturing facilities. DRB is responsible for the evaluation and regulation of devices used for immunohematology testing, molecular typing of red blood cells, blood establishment computer software, and HLA assays.

RESPONSIBILITIES: As a Staff Fellow/Visiting Associate (Scientific Reviewer) in the Device Review Branch, the selected candidate will be responsible for:

  • Conducting regulatory and science-based reviews of device applications submitted to the Agency.
  • Determining the safety and efficacy of medical device by evaluating submitted scientific data, as well as the test methods and description of devices contained in medical device submissions.
  • Providing expertise to the Center in the evaluation of molecular based devices, and participating in the development of Center policy, guidance and regulations for medical devices.
  • Performing inspection of facilities manufacturing medical devices.

QUALIFICATIONS

BASIC QUALIFICATIONS: General Natural Resources Management and Biological Sciences (0401): Degree in Biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position, – OR – Combination of education and experience: Courses equivalent to a major, plus appropriate experience or additional education.

ADDITIONAL QUALIFICATIONS: Ph.D. in Molecular Biology, Biochemistry or other relevant Biomedical Sciences or equivalent doctoral degree (M.D., D.V.M., DVM., or Sc.D. etc.) is required. Candidates must possess an exceptional written and oral communication skills, and experience in scientific critique.

REQUIRED SPECIALIZED EXPERIENCE: Candidates must have broad knowledge in the areas of molecular biology, red blood cell genotyping, and immunohematology. Basic knowledge in next generation sequencing is also preferred. Candidates must be technically advanced in the areas of molecular technologies, capable of independently evaluating scientific and technical issues raised during the review of regulatory submissions.

FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation.

SALARY: Salary is commensurate with education and experience.

LOCATION: Silver Spring, MD

CONDITIONS OF EMPLOYMENT: This position will be filled through the Service Fellowship program. The appointment is for up to four years with opportunities for renewal. Applications will be accepted from all groups of qualified candidates, including U.S. citizens or non-U.S. Citizens holding valid immigration status and work authorization at the FDA. No previous Federal experience is required. Appointment does not confer any entitlement to a position in the competitive service, and there is no entitlement to Merit Systems Protection Board (MSPB) appeals rights.

  • One-year probationary period may be required.
  • Official Transcripts required.
  • Background and/or Security investigation required.
  • If applicant is an U.S. Citizen, males born on, or after, December 31st, 1959 must be registered with the Selective Service System or have an approved exemption. Visit www.SSS.gov for more info.
  • Prohibited financial interest restrictions may apply. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office website at http://www.fda.gov/AboutFDA/WorkingatFDA/Ethics/default.htm.

HOW TO APPLY: Submit electronic resume or curriculum vitae with a cover letter containing a brief summary of scientific accomplishments and the names/contact information of three references to CBER Recruitment at CBER.Employment@fda.hhs.gov. Applications and all supporting documentation will be accepted through May 17th, 2021.  Please reference Job Code: OBRR-21-10-CJP.

ADDITIONAL INFORMATION: For additional information on CBER Careers, please visit:

HHS/FDA is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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