What are the responsibilities and job description for the FDA Laboratory Research Fellowship - Inhalation and Nasal Drug Products position at Oak Ridge Institute for Science and Education?
Organization
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CDER-2026-0172
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.CDER@orau.org. Please include the reference code for this opportunity in your email.
Application Deadline
3/31/2027 12:00:00 AM Eastern Time Zone
Description
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
Research Project: FDA advances the development and assessment of methods for evaluating inhaled and nasal drug products to fulfill its public health mission. Through collaboration with multidisciplinary scientists and reviewers across FDA offices, this research project will generate evidence to inform regulatory guidance and support the review and approval of new and generic respiratory drug products.
Learning Objectives: Under the guidance of a mentor, you will receive training in designing, planning, conducting, analyzing, and reporting high impact research on respiratory drug delivery systems. You will also gain experience through daily participation in laboratory research activities, including drug product manufacturing and characterization, in vitro performance testing, in silico modeling, and analytical method development and application. Through the program, you will also strengthen your scientific writing, data presentation, communication, and critical-thinking skills within a regulatory science research environment.
Mentor: The mentor for this opportunity is Yang Yang (Yang.yang@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.
Qualifications
The qualified candidate should have received a master's or doctoral degree in one of the relevant fields. Degree must have been received within the past five years.
Doctoral is preferred, but master's with desirable experience will also be considered.
Preferred Skills
Ashley
Eligibility Requirements">3 )
U.S. Food and Drug Administration (FDA)
Reference Code
FDA-CDER-2026-0172
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.CDER@orau.org. Please include the reference code for this opportunity in your email.
Application Deadline
3/31/2027 12:00:00 AM Eastern Time Zone
Description
- Applications will be reviewed on a rolling-basis.
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
Research Project: FDA advances the development and assessment of methods for evaluating inhaled and nasal drug products to fulfill its public health mission. Through collaboration with multidisciplinary scientists and reviewers across FDA offices, this research project will generate evidence to inform regulatory guidance and support the review and approval of new and generic respiratory drug products.
Learning Objectives: Under the guidance of a mentor, you will receive training in designing, planning, conducting, analyzing, and reporting high impact research on respiratory drug delivery systems. You will also gain experience through daily participation in laboratory research activities, including drug product manufacturing and characterization, in vitro performance testing, in silico modeling, and analytical method development and application. Through the program, you will also strengthen your scientific writing, data presentation, communication, and critical-thinking skills within a regulatory science research environment.
Mentor: The mentor for this opportunity is Yang Yang (Yang.yang@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.
Qualifications
The qualified candidate should have received a master's or doctoral degree in one of the relevant fields. Degree must have been received within the past five years.
Doctoral is preferred, but master's with desirable experience will also be considered.
Preferred Skills
- Experience in spray drying technology, powder and propellant filling into sealed canisters, particle technology /powder mechanics, physical pharmacy, or pharmaceutical science research is desirable.
Ashley
Eligibility Requirements">3 )
- Degree: Master's Degree or Doctoral Degree received within the last 60 month(s).
- Discipline(s):
- Chemistry and Materials Sciences (
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