INTRODUCTION: The Center for Devices and Radiological Health (CDRH or Center), the medical devices scientific and regulatory arm of the U.S. Food and Drug Administration (FDA), welcomes applications from Analytical Chemists to join our Sterility and Infection Program, as Staff Fellows, in the Office of Science and Engineering Laboratories (OSEL). These positions are located in OSEL’s Division of Biology, Chemistry, and Materials Science (DBCMS or Division), which focuses on a host of public health concerns in the areas of biocompatibility and toxicology, sterility and infection control, materials chemistry and performance, and nanotechnology.
POSITION SUMMARY: DBCMS is recruiting Staff Fellows with extensive experience in analytical chemistry techniques, such as liquid and/or gas chromatography-mass spectrometry (LC-MS, GC-MS), high-performance liquid chromatography (HPLC), and inductively coupled plasma mass spectrometry (ICP-MS) and their application to microbiological and material characterization. Additionally, you will utilize your experience in analyzing and identifying microorganisms using MALDI-TOF gained in the research and/or clinical settings. These positions involve laboratory research, policy interpretation, and consultation support for our medical device review teams throughout the Center. As integral members of the Division, you will develop new and innovative approaches to scientific testing of new and emerging medical devices and products in the areas of microbiology and/or chemical characterization.
DUTIES / RESPONSIBILITIES: As Staff Fellows, you will:
- Serve as a technical authority in the scientific analysis of the safety, effectiveness, reliability, and performance of medical devices and products regulated the FDA.
- Provide authoritative analysis of scientific and technical data submitted to the Agency for review.
- Generate written technical and scientific documents for peer-reviewed publications and consulting support activities.
- Utilize expert scientific and vast technical knowledge to serve as an advisor and consultant on regulations and policies involving complex and high priority matters affecting the regulation of new medical devices in the areas of material science and chemical characterization.
- Draft and share medical device and product review recommendations of national public health significance, which may impact the availability of certain products due to safety, efficacy, and reliability concerns, with Division and Office leadership.
PROFESSIONAL EXPERIENCE / KEY REQUIREMENTS: To qualify, you must demonstrate in your resume the necessary experience, which is equivalent to the following:
- Ph.D. from an accredited university in Analytical Chemistry, Polymer Chemistry, Materials Science, or related scientific fields.
- A minimum of three (3) years of postgraduate experience in planning and conducting research in microbiological identification and Characterization using MALDI-TOF and chemical characterization of medical device materials.
- Experience in reviewing, analyzing, and using scientific data or other information to advance and convey understanding of chemical characterization in medical device examination, including understanding ISO 10993 – part 18, as well as use and understanding all other medical device related standards.
- Excellent scientific writing and communication skills. Knowledge of the scientific principles and practices associated with designing experiments to address research topics in microbiology, chemical characterization materials, and data science.
BASIC QUALIFCATIONS: Applicants must meet the specific qualification requirements of the following applicable occupational series: Materials Engineering (0806), Bioengineering and Biomedical Engineering (0858), Chemical Engineering (0893), Chemistry (1320).
ADDITIONAL QUALIFCATIONS: To qualify as a Staff Fellow, you must: be a US Citizen, Permanent Resident, or Non-Citizen with residency status in the U.S., three (3) out of the last five (5) years; possess a doctoral-level degree from an accredited institution of higher learning, including: Ph.D., M.D., D.V.M., D.D.S., D.M.D., Sc.D., or other research doctoral-degree widely recognized in U.S. academe as equivalent to a Ph.D.. (In limited instances non-doctoral candidates, and/or candidates with less experience may be acceptable).
FOREIGN EDUCATION: Candidates who have completed part or all of their education outside the United States must, in order to meet qualification requirements, have their foreign education evaluated by an accredited organization to ensure the foreign education is comparable to education received in the United States. It is the responsibility of the candidate or employee to provide written proof of her/his foreign education accreditation prior to appointment or placement in a different occupational series from which placed. For further information, visit the U.S. Department of Education - Foreign Education Evaluation.
CONDITIONS OF EMPLOYMENT
- One-year probationary period may be required.
- This position is for a three-year appointment and will be filled through FDA’s Staff Fellowship Program
- Background and/or Security investigation required.
- Applicants who are U.S. Citizens and born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For additional information, please visit the FDA Ethics and Integrity Office: https: www.fda.gov/about-fda/office-operations/office-ethics-and-integrity All candidates must meet applicable security requirements which include a background check and a minimum of three (3) out of the past five (5) years’ residency status in the US. If not previously completed, a background security investigation will be required for all appointees. Appointment will be subject to the applicant’s successful completion of a background security investigation and favorable adjudication. Failure to successfully meet these requirements may be grounds for appropriate personnel action. In addition, if hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection, or appropriate disciplinary action. To ensure compliance with an applicable preliminary nationwide injunction, which may be supplemented, modified, or vacated, depending on the course of ongoing litigation, the Federal Government will take no action to implement or enforce the COVID-19 vaccination requirement pursuant to Executive Order 14043 on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees. Therefore, to the extent a federal job announcement includes the requirement that applicants must be fully vaccinated against COVID-19 pursuant to Executive Order 14043, that requirement does not currently apply. Federal agencies may request information regarding the
vaccination status of selected applicants for the purposes of implementing other workplace safety protocols, such as protocols related to masking, physical distancing, testing, travel, and quarantine.
LOCATIONS: FDA’s White Oak Campus in Silver Spring, Maryland
SALARY: Salary starts at $106,823.00 and is commensurate with education and post-PhD experience.
BENEFITS: A comprehensive benefits package is offered to most Federal employees. For additional benefit information, please visit: https://www.opm.gov/healthcare-insurance/Guide-Me/New-Prospective-Employees/
HOW TO APPLY: Prior to applying, please see the following instructions:
- Submit an electronic resume or curriculum vitae and a cover letter describing why you are uniquely qualified for this job.
- Include Job Reference code “2020-OSEL-DBCMS-053” in the email subject line.
- Email applicant package to CDRH-OSEL-Opportunities@fda.hhs.gov. Applications with supporting documentation will be accepted through October 19, 2022. Visit CDRH Jobs https://www.fda.gov/about-fda/jobs-and-training/jobs-center-devices-and-radiological-health-cdrh, to see additional opportunities. Contact Denise Townsend for questions: Denise.Townsend@fda.hhs.gov
The United States Government equal opportunity employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service or other non-merit factor.