FDA Fellowship in Development and Control of Cell Manufacturing Platform Technologies

Reference Code

FDA-CDER-

3/31/2027 12:00:00 AM Eastern Time Zone

If you have questions, send an email to ORISE.FDA.CDER. Please include the reference code for this opportunity in your email.

Applications will be reviewed on a rolling-basis.

A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) located in Silver Spring, Maryland.

Under the guidance of a mentor, you will engage in a hands‑on learning experience involving Cell‑free protein synthesis (CFPS) utilizing mammalian and prokaryotic extracts. This is a developing manufacturing technology that enables the rapid, decentralized, and on‑demand production of life‑saving therapeutics and medical countermeasures. However, the lack of standardized quality control assays and the inherent batch‑to‑batch variability of the biological raw materials pose significant regulatory challenges for broader implementation.

Currently, there is a gap in establishing a robust Chemistry, Manufacturing, and Controls (CMC) framework to ensure the consistent quality of products derived from these diverse platforms. We propose to develop cell free manufacturing platform technology and validate robust analytical procedures to characterize the critical material attributes (CMAs) of both mammalian (e.g., CHO, HeLa) and prokaryotic (e.g.,

E. coli) cell extracts to systematically assess their viability and reproducibility for safe and effective biomanufacturing.

Improve or advance science‑based quality standards and manufacturing practices to assure product quality, safety, and efficacy & identify, evaluate, and understand emerging product, manufacturing, and analytical testing technologies to aid in risk‑based quality assessment and support standards, policy and guidance development.

• Execution of mammalian and prokaryotic cell‑free protein synthesis reactions, actively developing and qualifying analytical assays (e.g., fluorometric assays, HPLC, ceSDS) to monitor extract productivity, batch‑to‑batch variability, and overall protein quality.
• Weekly meetings with mentor to assess progress and provide targeted training, review experimental data, and discuss how the data applies to current CMC regulatory frameworks.
• Training on how to deliver research findings to a scientific audience by presenting at internal FDA meetings and actively participating in the drafting of a manuscript for a peer‑reviewed scientific journal.
• Biweekly meetings to learn scientific knowledge in a variety of disciplines.

You will gain and advance your current scientific skill set in cutting‑edge biomanufacturing and analytical characterization. Additionally, you will learn how to interpret complex scientific data, perform advanced laboratory techniques, and apply ICH guidelines to experimental design. You will also learn how to communicate research findings effectively, bridging the gap between bench science and regulatory policy. Your training and acquired skill set will have applicability across scientific disciplines to ensure you have the opportunity to choose different career paths in academia, industry, or the federal government.

• Receive hands‑on training in advanced analytical techniques and cell‑free biomanufacturing workflows (spanning both prokaryotic and mammalian systems) to advance your technical skillset.
• Improve scientific knowledge regarding FDA regulatory science, Quality by Design (QbD), and CMC requirements.
• Learn about laboratory‑scale extract production, qualification, and protein synthesis.
• Improve scientific…