The Food and Drug Administration (FDA) is seeking an Interdisciplinary Scientist with bioanalytical expertise in the Division of Applied Regulatory Science (DARS), Office of Clinical Pharmacology (OCP), located in the Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), FDA. Working at the FDA, you can make a difference in the lives of every American, helping to make their world healthier, safer and better. This position represents an excellent career opportunity to work in a visible, high priority program area that has the potential to alter in a substantive way the direction of drug development at the national level.
DARS seeks to move new science into the regulatory review process and close the gap between scientific innovation and medical product review. DARS does this by 1) conducting mission-critical applied research to develop and evaluate tools, standards and approaches to assess the safety, efficacy and performance of drugs and 2) performing expert regulatory review consultations for scientific issues and needs that emerge during the premarket or postmarket review of drug safety and efficacy. See DARS Annual Report https://go.usa.gov/xdKbQ for more information about the Division. The Division conducts many nonclinical and clinical research studies requiring bioanalysis.
As an Interdisciplinary Scientist with bioanalytical expertise, the incumbent will serve in a multidisciplinary research division that integrates scientific innovation and regulatory review. DARS forms scientific teams “on demand” to perform mission-critical research and expert regulatory review consultations.
The incumbent will conduct laboratory bioanalysis work and should have:
2-3 years of experience in high performance liquid chromatography (HPLC) and liquid chromatography with tandem mass spectrometry (LC-MS/MS) small molecule quantitation (i.e. xenobiotics, biomarkers) in samples from pre-clinical and/or clinical (ideally both) studies.
Skilled in conducting research, compiling data, data interpretation, and writing reports according to regulatory requirements
Expert in performing the upkeep, maintenance and troubleshooting of instruments (e.g. LC-MS/MS)
Ability to regularly lead the development of new, innovative bioanalytical approaches and experimental designs
Ability to identify patterns, trends & connections across data to reveal new dimensions to problems/solutions and articulate those ideas
Knowledge of laboratory automation software, system software, and Microsoft applications
Excellent verbal and written communication skills, demonstrated creativity
Ability to work in a team environment with cross-functional interactions
Skilled in performing scientific presentations and preparing scientific publications
Desirable experience and skill set also includes: Ability to multi-task in a highly dynamic environment and flexibility to work in a fast-paced team in a professional and pleasant manner, experience in large molecule quantitation using immunoassays and mass spectrometry, and knowledge of drug metabolism and/or pharmaceutics
GENERAL INFORMATION: Candidates for this position must be U.S. citizens or have lived in the U.S. for 3 out of the last 5 years.
Basic Requirements: Degree: A doctoral-level degree from an accredited institution of higher learning, including: Ph.D., M.D., Pharm.D., or other research doctoral-degree widely recognized in U.S. academe as equivalent to a Ph.D. in Biological Sciences, Pharmacology, Chemistry, or Pharmacy.
Salary: Commensurate with education and experience. An excellent benefits package is also available.
Location: Silver Spring, Maryland.
Please submit your CV/resume and cover letter by April 3, 2020 to: DARSrecruitment@fda.hhs.gov. In the subject line of your submission email and in your cover letter, please designate DARS Interdisciplinary Scientist Bioanalytical Position.
ALL APPLICATIONS WILL RECEIVE EQUAL CONSIDERATION WITHOUT REGARD TO RACE, ORIGIN, COLOR, RELIGION, SEX, DISABILITY, OR ANY OTHER NON-MERIT FACTOR. FDA IS AN EQUAL OPPORTUNITY EMPLOYER AND HAS A SMOKE FREE ENVIRONMENT.