What are the responsibilities and job description for the FDA Fellowship - International Standards and Methods position at Oak Ridge Institute for Science and Education?
Organization
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CBER-2026-0048
How To Apply
To submit your application, scroll to the bottom of this opportunity and click APPLY.
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
6/19/2026 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: You will join a research program that: (i) Investigates the mechanism(s) of coagulation in the context of drugs used to treat bleeding disorders. (ii) Develops national and international standards and methods for the measurement of the potency of coagulation proteins used as drugs. You will carry out studies on human and mouse blood plasma supplemented with coagulation factor proteins to investigate the mechanisms of coagulation and drug action. The experiments will include enzymatic, clotting, antigen and thrombin generation assays. Mouse models may be used to study drug pharmacokinetics and pharmacodynamics. You will receive mentoring on the project, which will also include collaboration with investigators within and external to the FDA.
The following articles from our laboratory provide examples of research performed in our group:
Mentor: The mentor for this opportunity is Zuben E. Sauna (zuben.sauna@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.
Participant Stipend: The participant will receive a monthly stipend commensurate with educational level and experience.
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 or be currently pursuing a master's or doctoral degree in one of the relevant fields (e.g. Immunology, Biochemistry, Biology, Pharmacy or Pharmaceutical Sciences), or be currently pursuing one of the degrees with completion before the appointment start date. Degree must have been received within five years of the appointment start date, or be currently pursuing.
Preferred Skills
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Eligibility Requirements">12 )
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CBER-2026-0048
How To Apply
To submit your application, scroll to the bottom of this opportunity and click APPLY.
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
6/19/2026 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: You will join a research program that: (i) Investigates the mechanism(s) of coagulation in the context of drugs used to treat bleeding disorders. (ii) Develops national and international standards and methods for the measurement of the potency of coagulation proteins used as drugs. You will carry out studies on human and mouse blood plasma supplemented with coagulation factor proteins to investigate the mechanisms of coagulation and drug action. The experiments will include enzymatic, clotting, antigen and thrombin generation assays. Mouse models may be used to study drug pharmacokinetics and pharmacodynamics. You will receive mentoring on the project, which will also include collaboration with investigators within and external to the FDA.
The following articles from our laboratory provide examples of research performed in our group:
- Parunov LA, Shea ME, Liang Y, Surov SS, Chattopadhyay M, Lee TK, Scott DE, Ovanesov MV. Thrombin generation test based on a 96-channel pipettor for evaluation of FXIa procoagulant activity in pharmaceuticals. Nat Protoc. 2021 Aug;16(8):3981-4003.
- Liang Y, Tarandovskiy I, Surov SS, Ovanesov MV. Comparative Thrombin Generation in Animal Plasma: Sensitivity to Human Factor XIa and Tissue Factor. Int J Mol Sci. 2023 Aug 18;24(16):12920.
- Liang Y, Jackson JW, Woodle SA, Surov SS, Parunov LA, Scott DE, Weinstein M, Lee TK, Ovanesov MV. Detecting factor XIa in immune globulin products: Commutability of international reference materials for traditional and global hemostasis assays. Res Pract Thromb Haemost. 2020 Dec 23;5(1):211-222.
- Jackson JW, Surov SS, Liang Y, Parunov LA, Ovanesov MV. Effect of pH on thrombin activity measured by calibrated automated thrombinography. Res Pract Thromb Haemost. 2020 Jun 12;4(5):944-945.
Mentor: The mentor for this opportunity is Zuben E. Sauna (zuben.sauna@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.
Participant Stipend: The participant will receive a monthly stipend commensurate with educational level and experience.
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 or be currently pursuing a master's or doctoral degree in one of the relevant fields (e.g. Immunology, Biochemistry, Biology, Pharmacy or Pharmaceutical Sciences), or be currently pursuing one of the degrees with completion before the appointment start date. Degree must have been received within five years of the appointment start date, or be currently pursuing.
Preferred Skills
- Experience in mammalian cell culture, cell-based assays, and flow cytometry
- Experience in advanced techniques in immunology, biochemistry, molecular biology, cell biology
- Familiarity with basic techniques and principles in cell and molecular biology and biochemistry
- Willing to learn new technologies and methods and operate outside their comfort zone
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Eligibility Requirements">12 )
- Degree: Master's Degree or Doctoral Degree received within the last 60 months or currently pursuing.
- Discipline(s):
- Chemistry and Materials Sciences (
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