WRAIR - Manufacturing Practice; GMP Quality Control Internship

How To Apply

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U.S. Department of Defense (DOD)

MRDC-WRAIR-

The Walter Reed Army Institute of Research (WRAIR) is offering graduate student fellowships at the Silver Spring, Maryland facility.

As an Oak Ridge Institute for Science and Education (ORISE) participant, you will join a community of scientists and researchers in an effort to conduct process development and Good Manufacturing Practices (GMP) production of vaccine and biologics candidates intended for use in early phase clinical trials. As such, the approach for use of facility isolates should be scientifically justified and minimally meet regulatory requirements.

Under the guidance of a mentor, you will gain hands‑on experience to complement your education and support your academic and professional goals. Along the way, you will engage in activities and research in several areas. These include, but are not limited to:

• Gaining experience with the Pilot Bioproduction Facility (PBF) Quality Control (QC) team in the creation of a robust facility isolate identification program
• Learning the clinical trials process from start to finish, including SOP and batch record generation and identifying analytical testing requirements
• Participating with the Analytical Sciences and Technology team to reestablish the Microneutralization viral testing capabilities
• Becoming familiar with operations in cGMP production environments
• Learning technology transfer process and documentation
• Gaining experience in Engineering and facility operations within a cGMP facility

Silver Spring, Maryland

Exact start dates will be determined at the time of selection and in coordination with the selected candidate. Applications are reviewed on an ongoing basis and fellowships will be filled as qualified candidates are identified.

This appointment is a twelve‑month research appointment, with the possibility to be renewed for additional research periods. Appointments may be extended depending on funding availability, project assignment, program rules, and availability of the participant.

You will receive a stipend to be determined by WRAIR. Stipends are typically based on a participant’s academic standing, discipline, experience, and research facility location. Other provisions may include the following:

• Health Insurance Supplement (Participants are eligible to purchase health insurance through ORISE)
• Relocation Allowance
• Training and Travel Allowance

The Walter Reed Army Institute of Research (WRAIR) aims to conduct biomedical research that is responsive to Department of Defense and U.S. Army requirements and delivers lifesaving products including knowledge, technology and medical material that sustain the combat effectiveness of the warfighter. WRAIR provides unique research capabilities and innovative medical solutions to a range of Force Health Protection and Readiness challenges currently facing U.S. Service Members, along with threats anticipated during future operations.

The Pilot Bioproduction Facility (PBF) at the WRAIR is a Good Manufacturing Practices (GMP)-compliant facility specializing in the production of vaccines and biologics for use in Phase 1 clinical trials. The PBF focuses on transitioning Research and Development processes into those suitable for manufacturing and accelerating product advancement into first‑in‑human studies.

This program, administered by Oak Ridge Associated Universities (ORAU) through its contract with the U.S. Department of Energy (DOE) to manage the Oak Ridge Institute for Science and Education (ORISE), was established through an interagency agreement between DOE and DoD. Participants do not enter an employee/employer relationship with ORISE, ORAU, DoD or any other office or agency. Instead, you will be affiliated with ORISE for the administration of the appointment through the ORISE appointment letter and Terms of Appointment.

Proof of health insurance is required for…