FDA Postdoctoral Fellowship - Investigating Effects of Cell-Materials Interactions S

FDA Office and Location

Cellular and Tissue Therapy Branch (CTTB), Office of Therapeutic Products (OTP), Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) in Silver Spring, Maryland.

This is part of a collaborative research program with the Massachusetts Institute of Technology (MIT), providing a unique opportunity to collaborate closely with investigators at both institutions. As a selected fellow you will conduct research at FDA and MIT facilities and participate in interdisciplinary projects at the interface of regulatory science and biomedical engineering.

CBER’s mission is to ensure the safety, purity, potency, and effectiveness of biological products including vaccines, blood and blood products, and cells, tissues, and gene therapies. The project will explore methods and approaches to improve the manufacture of small extracellular vesicles (sEV), formerly known as exosomes, based therapeutics. Under the guidance of investigators, the applicant will apply engineering, cell culture, and microbiology techniques to investigate the biogenesis, production, and purification of sEV from cell culture in bioreactors.

The overall objective is to increase knowledge and understanding of the parameters that impact the quantity and quality of sEV production.

Through this fellowship you will learn about the production of sEV, an emerging and cutting‑edge biological product with the potential to address gaps in drug delivery and treatment.

Kyung Sung (kyung.sung.gov). Contact the mentor for questions about the nature of the research.

Anticipated Appointment

Start Date:

No later than September 30, 2026 (flexible).
Appointment Length: Initially one year, may be renewed.
Level of Participation: Full time.
Participant Stipend: Monthly stipend commensurate with educational level and experience.

Citizenship: U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non‑U.S. citizens must meet valid immigration status requirements. Proof of health insurance is required. Participants are not employees of FDA, DOE, or program administrator and receive no employment‑related benefits.

Background investigation by the Office of Personnel Management is required for onboarding. OPM can investigate individuals who have resided in the U.S. for a total of three of the past five years.

ORISE Fellows and their spouses/children must report any SRO or prohibited investment fund financial interest or relationship. Failure to divest or terminate relationships results in non-placement. Refer to FDA Ethics for Non‑employee Scientists for additional requirements.

Participants must read and sign the FDA Education and Training Agreement within 30 days of start. The agreement covers provisions such as the non‑employee nature of the appointment, prohibition of inherently governmental functions, IP obligations, property of research materials, and confidentiality requirements.

• Ph.D. in biochemical or chemical engineering, biological sciences, or related field received within five years of appointment start date.

• Experience with growth of mammalian cells (e.g., MSCs or HEK
  293).
• Experience in production, measurement, and characterization of sEVs (e.g., nanoparticle tracking, immunoblotting for sEV markers, TEM).
• Experience analyzing cell culture medium components using HPLC, ELISA, or similar methods.
• Ability to prioritize multiple activities, troubleshoot technical issues, develop and execute detailed protocols, and work independently as well as in teams.
• Excellent documentation and oral and written communication skills.
• Experience with bioreactor set‑up, operation, and maintenance.

Ashley

• Degree:
  Doctoral Degree received within the last 60 months.
• Discipline(s):
  Engineering, Life Health and Medical Sciences.

I am a U.S. citizen, or I have lived in the United States for at least 36 out of the past 60 months. I have read the FDA Ethics Requirements.