This position is located in the U.S. Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Regulatory Science (ORS), Detroit Laboratory.
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Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.
The Detroit Laboratory and ORS are parts of the Office of Regulatory Affairs, which oversees all science field work performed by the FDA. The Detroit Laboratory is a regulatory laboratory that specializes in drug work. It is one of the smaller laboratories and currently has 14 chemists, seven microbiologists, one physical science technician and one biological science technician on staff. Currently, research is a very small part of our work plan. The lab is A2LA certified - ISO 17025, so work products must conform to QMS system requirements and SOP, and instrument qualifications are reviewed and done on a routine.
This opportunity will be filled through FDA's Staff Fellowship Program. The appointment is for three years with opportunities for renewals.
This is an Excepted Service position under Title 42. Applications will be accepted from all groups of qualified persons, including non-citizens. No previous Federal experience is required. This appointment does not confer any entitlement to conversion to a position in the competitive service and no entitlement to Merit Systems Protection Board (MSPB) appeal rights.
Additional selections may be made.
The selectee will support existing laboratory resources in various endeavors focusing primarily on enhancing analytical expertise in the field of analytical chemistry. Method development, validation and verification, research assignments will be very specific in nature and carefully planned. The candidate will participate in collaborative efforts assisting with monograph modernization, pharmacy compounding verification, and development based projects in support of regulatory programs. Basic duties would entail qualifying new lots of U. S. Pharmacopeia Standards, standard lot qualification using High Performance Liquid Chromatography (HPLC) methods for chromatographic purity testing, Fourier Transform Infrared (FTIR), Karl Fisher Titration (KF) water, loss on drying, and Thermal Gravimetric Analysis (TGA).