What are the responsibilities and job description for the FDA Fellowship in Understanding Hepatitis C Virus Diversity During Acute Phase Infection position at Oak Ridge Institute for Science and Education?
Organization
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CBER-2026-0038
How To Apply
Connect with ORISE...on the GO! Download the new ORISE GO mobile app in the Apple App Store or Google Play Store to help you stay engaged, connected, and informed during your ORISE experience and beyond!
A Complete Application Consists Of
If you have questions, send an email to ORISE.FDA.CBER@orau.org. Please include the reference code for this opportunity in your email.
Application Deadline
5/29/2026 3:00:00 PM Eastern Time Zone
Description
The Center for Biologics Evaluation and Research (CBER) is one Center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services. CBER's mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.
Research Project: RNA viruses, such as hepatitis C virus, present extraordinary diversity that could impact vaccine design and effectiveness. HCV infection is a serious public health concern and currently there is no effective vaccine. About 70% of people that become infected with the virus develop persistent infections that can, in later life, lead to severe liver problems. Despite many studies on viral diversity, little is known about how quickly the virus acquires mutations immediately following infection, termed the acute phase of infection, as most studies have focused on samples isolated from late phase, persistent infections when the virus has been replicating for several years within the host.
In this project, we will use previously acquired sequential serum samples from chimpanzees infected with HCV of a single sequence to investigate the accumulation of mutations over time. Next generation sequence analysis will be performed on full-length cDNA products to assess diversity within and between infections over a period of 1 to 2 years. If selected, you will collaborate with other lab members to develop skills in PCR (to generate long (11 kb) PCR fragments), next generation sequencing and bioinformatics analysis. The results of this work will provide new insights into HCV diversity and help guide the development approaches to test new HCV vaccines.
Learning Objectives: Under the guidance of a mentor, you will learn to apply molecular biology techniques to generate cDNA for next generation sequence (NGS) analysis and develop bioinformatic skills to analyze large sequence data sets. You will understand the complexities and application of NGS to inform on viral diversity and vaccine development. The acquired knowledge and skillset will be applicable to the analysis of a wide range of infectious agents.
Mentor: The mentor for this opportunity is Marian Major (Marian.Major@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.
Anticipated Appointment Start Date: 2026. Start date is flexible and will depend on a variety of factors.
Appointment Length: The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.
Level of Participation: The appointment is full time.
Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.
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 participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. 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 Ethics Requirements
If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.
Education
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:
The qualified candidate should have received a bachelor's or master's degree in one of the relevant fields. The degree must have been received within 3 years of the appointment start date.
Preferred Skills/Knowledge
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Eligibility Requirements">51 )
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CBER-2026-0038
How To Apply
Connect with ORISE...on the GO! Download the new ORISE GO mobile app in the Apple App Store or Google Play Store to help you stay engaged, connected, and informed during your ORISE experience and beyond!
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
If you have questions, send an email to ORISE.FDA.CBER@orau.org. Please include the reference code for this opportunity in your email.
Application Deadline
5/29/2026 3:00:00 PM Eastern Time Zone
Description
- Applications will be reviewed on a rolling-basis.
The Center for Biologics Evaluation and Research (CBER) is one Center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services. CBER's mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.
Research Project: RNA viruses, such as hepatitis C virus, present extraordinary diversity that could impact vaccine design and effectiveness. HCV infection is a serious public health concern and currently there is no effective vaccine. About 70% of people that become infected with the virus develop persistent infections that can, in later life, lead to severe liver problems. Despite many studies on viral diversity, little is known about how quickly the virus acquires mutations immediately following infection, termed the acute phase of infection, as most studies have focused on samples isolated from late phase, persistent infections when the virus has been replicating for several years within the host.
In this project, we will use previously acquired sequential serum samples from chimpanzees infected with HCV of a single sequence to investigate the accumulation of mutations over time. Next generation sequence analysis will be performed on full-length cDNA products to assess diversity within and between infections over a period of 1 to 2 years. If selected, you will collaborate with other lab members to develop skills in PCR (to generate long (11 kb) PCR fragments), next generation sequencing and bioinformatics analysis. The results of this work will provide new insights into HCV diversity and help guide the development approaches to test new HCV vaccines.
Learning Objectives: Under the guidance of a mentor, you will learn to apply molecular biology techniques to generate cDNA for next generation sequence (NGS) analysis and develop bioinformatic skills to analyze large sequence data sets. You will understand the complexities and application of NGS to inform on viral diversity and vaccine development. The acquired knowledge and skillset will be applicable to the analysis of a wide range of infectious agents.
Mentor: The mentor for this opportunity is Marian Major (Marian.Major@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.
Anticipated Appointment Start Date: 2026. Start date is flexible and will depend on a variety of factors.
Appointment Length: The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.
Level of Participation: The appointment is full time.
Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.
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 participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. 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 Ethics Requirements
If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.
Education
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.
The qualified candidate should have received a bachelor's or master's degree in one of the relevant fields. The degree must have been received within 3 years of the appointment start date.
Preferred Skills/Knowledge
- Candidates with research experience in molecular biology, cell culture and immunology are encouraged to apply.
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Eligibility Requirements">51 )
- Degree: Bachelor's Degree or Master's Degree received within the last 36 months or currently pursuing.
- Discipline(s):
- Life Health and Medical Sciences (
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