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) is recruiting to fill a Senior Staff Fellow/Visiting Scientist position to serve as a Principal Investigator (PI) in the Laboratory of Pathogen Reduction Research (LPRR). LPRR aims to develop novel technologies for pathogen reduction of whole blood that can be used in the manufacturing of blood components for transfusion (see https://pubmed.ncbi.nlm.nih.gov/31144334/ for additional information).

This is a Principal Investigator opportunity in biomedical engineering to establish a program on pathogen inactivation in stored blood and blood components.

RESPONSIBILITIES: The successful candidate will lead laboratory research efforts to design, develop proofs of concept, and evaluate novel pathogen reduction technologies to support and facilitate the safety of the nation’s blood supply from known and unknown infectious diseases. The candidate will have opportunities in this area to learn and receive training to contribute to FDA policy and guidance development activities, and to participate in the review of regulatory filings submitted to the Office. The selected candidate will be responsible for, but not limited to, the following:

• As a PI, lead a self-directed laboratory research program focusing on developing novel technologies appropriate for inactivation/reduction of transfusion-transmitted pathogens in whole blood and blood components.
• Collaborating with OBRR principal investigators to test newly identified pathogen reduction/inactivation concepts related to transfusion-transmitted infectious agents (bacterial, viral, and protozoan parasites) and optimize pathogen reduction approaches.
• Communicating results and their interpretation to a diverse audience, including FDA scientists, collaborators, and external stakeholders.

SALARY: Salary is commensurate with education and experience, including an excellent benefits package.

LOCATION: FDA White Oak Campus in Silver Spring, MD

CONDITIONS OF EMPLOYMENT: This position will be filled through the Service Fellowship program, with an initial appointment period followed by 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 during the initial appointment there is no entitlement to Merit Systems Protection Board (MSPB) appeals rights.

• One-year probationary period may be required.
• Official Transcripts are 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 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.
• This position is subject to Executive Order 14043, mandating covid-19 vaccination for federal employees.

HOW TO APPLY: Submit a curriculum vitae, cover letter, and a statement of research interests. Your statement of research interests (no more than 2 pages) should contain a high-level description of how you would develop a research program in pathogen reduction for blood safety and state how your education and experience would be applicable to your research program. The application should also include the names/contact information of three references. Please submit applications to CBER Recruitment at CBER.Employment@fda.hhs.gov. Applications and all supporting documentation will be accepted through September 23, 2022.  Please reference Job Code: OBRR-22-20-BES

BASIC QUALIFICATIONS: Applicants will be required to meet the specific qualification requirements of the applicable occupational series below.

Bioengineering and Biomedical Engineering Series, (RG-0858): Degree in bioengineering, biomedical engineering, or chemical engineering; or biology, chemistry, or basic medical science that include at least 20 semester hours in bioengineering and other subjects related to the study of bioengineering, and 20 semester hours in physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent. – OR – Combination of education and experience: Courses equivalent to a major in bioengineering, biology, chemistry, or basic medical science that included courses as above, plus appropriate experience or additional education.

ADDITIONAL QUALIFICATIONS: Ph.D. in Bioengineering, Biomedical Engineering, Chemical Engineering, Medical Science, Biological Science, or equivalent doctoral degree (M.D., D.V.M., or Sc.D. etc.) is required. Experience with microbiology or virology is desirable, but not required for consideration. Candidates must have demonstrated collaborative skills, excellent written and oral communication skills, and clear evidence of potential for leading a small research group. Knowledge of FDA regulations applicable to in vitro diagnostics and biological products is desirable, but not required for consideration.

PREFERRED SPECIALIZED EXPERIENCE:

• Demonstrated research experience in bioengineering, biomedical engineering, or related fields.
• Experience in handling, processing, or otherwise modifying blood and blood components.
• Experience in studying pathogens relevant to transfusion-transmitted infection, including quantifying infectivity and neutralization or inactivation of infectious agents (e.g., viruses, bacteria, and parasites) and in small animal models as appropriate.
• Experience with current biochemistry and molecular biology techniques and analytical tools.

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.