Staff Fellow - Analytical Chemist
Announcement Number: CDRH-OSEL-DBCMS (OSEL-13)
Position Title: Chemist (Analytical/Biophysical/Physical)
This position will be filled utilizing Title 42(g) authority
Salary Range: $99,172 - $152,352
Open Date: July 9, 2019
Close Date: August 2, 2019
Position Information: Full Time
Duty Location: Silver Spring, MD
Who may be considered: US Citizens, Permanent Residents, and Non-Citizens with residency status in the US, 3 out of the last 5 years.
Security Clearance: Public Trust - Background
The Division of Biology, Chemistry, and Materials Science (DBCMS) of the FDA's Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL) has an opening in Silver Spring, MD for a Chemist with expertise in Analytical, Biophysical or Physical Chemistry. We require a candidate with a major concentration in one or more of the following areas: materials characterization, polymer chemistry/physics, chemical engineering and materials science. We are seeking a candidate with laboratory experience in chemical characterization (particularly on the study of leachables and extractables), polymer degradation, and biomechanical compatibility/stability of materials/polymers used in medical device applications. The candidate should have experience in analytical chemistry techniques such as liquid chromatography-mass spectrometry (LC-MS), gas chromatography-mass spectrometry (GC/MS), high-performance liquid chromatography (HPLC), and inductively coupled plasma mass spectrometry (ICP-MS). The position involves approximately 50% laboratory research and 50% consulting support for applications requiring the review of chemistry and performance of polymeric and non-polymeric (eg, metals) materials used in new medical devices.
- Lead and conduct regulatory science experimental research to identify, quantify and characterize materials used in medical devices, with the aim of studying the chemical, structural, thermodynamic and kinetic properties of polymeric/ biopolymeric/biologic material systems used in medical devices and combination products. The research should address a significant regulatory science need in the realm of analytical chemistry and materials science that would broadly inform the design, manufacturing, testing, regulation and/or use of polymeric/ biopolymeric/biologic medical devices and combination products, as well as aid in forecasting of emerging regulatory science needs in this scientific space.
- Conducts regulatory consult reviews as part of a multidisciplinary team of scientists, engineers, physicians, epidemiologists and other specialists. Serves as a senior-level reviewer of analytical chemistry and/or materials science data submitted in support of a variety of medical device and combination product submissions, such as premarket approval applications (PMAs), applications for investigational device exemptions (IDEs), premarket notifications (510(k)s) of intent to market a device, and reports such as establishment inspection reports (EIRs). Interacts with submission sponsors regarding the development of analytical chemistry and characterization testing protocols for highly complex medical devices and combination products. Ensures, through careful communication, that the sponsors provide adequate product and feature descriptions to inform a regulatory decision on the safety and effectiveness of the device.
- Applicants should possess a Ph.D., or equivalent science degree in Analytical Chemistry, Biophysical Chemistry, Physical Chemistry, Chemical Engineering or related field; postdoctoral research experience is preferred.
- Minimum two to five years of experience planning and conducting state-of-the-art research, and reviewing, analyzing, and using scientific data to assess the safety and performance of medical device materials.
- Excellent skills in written and oral communication.
How will you be evaluated:
This application will be evaluated in accordance to your education and experience to the needs of the position. Those determined to be "best qualified" will be referred to the selecting official for further consideration.
How to apply:
To apply for this announcement, applicants must provide a complete application package which includes: (a) cover letter with compensation requirements; (b) curriculum vitae; and (c) list of three references.