This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.

Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act

Introduction

The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multi-billion-dollar industries, in addition to protecting the health and safety of American Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the United States.

The mission of the Office of Regulatory Affairs (ORA) is to protect consumers/patients and enhance public health by ensuring timely access to safe, quality FDA-regulated products. To view our ORA Vision, Mission, and Values please visit: https://www.fda.gov/about-fda/fda-organization/office-regulatory-affairs.

The Office of Regulatory Affairs (ORA) is at the forefront of building a public health safety net for today’s complex, global regulatory environment. ORA professionals work in a range of program areas and locations, with 227 offices and 12 laboratories throughout the United States. As the lead office for all FDA field activities, ORA serves as the agency’s direct connection with regulated industry through a) inspections of firms and plants producing FDA-regulated products, b) investigations of consumer complaints, emergencies and criminal activity, c) enforcement of FDA regulations, d) sample collection and analysis, and e) review of imported products.

The Office of Regulatory Science (ORS) provides strategic leadership, coordination, and expertise to the Associate Commissioner for Regulatory Affairs (ACRA), Deputy Associate Commissioner for Regulatory Affairs (DACRA) and other ORA senior leaders on scientific issues related to policy and regulations.

The Office of Human & Animal Food Laboratory Operations (OHAFLO) advises the ORS on scientific issues related to human and animal food laboratory operations and provides strategic leadership and support for high quality, collaborative, scientific activities that advance regulatory science and address important public health issues concerning the Food and Drug Administration (FDA) regulated products, including their evaluation, quality, safety, and effectiveness.

Duties/Responsibilities

The Chemist (Advanced Analyst) serves as an analytical instrumentation specialist within the Irvine Human and Animal Food Laboratory (IRVLHAF) where they are recognized as the expert, technical authority, and resource person in this specialization. Examples of highly technical chemistry instrumentation include—but are not limited to: Liquid or Gas Chromatography with Tandem Mass Spectrometry (LC-MS/MS)/ triple quadrupole mass spectrometer (QQQ), High-performance liquid chromatography (HPLC, Mass Spectrometry (MS), and Electron Microscopy (EM).

Conducts sample analysis using approved analytical procedures in various areas of agency concern to identify and quantify contaminants and adulterants in FDA-regulated products. Formulates and conducts research that evaluates new chemistry instrumentation and its applicability to the required analyses. Plans and performs the development of analytical methods in accordance with FDA needs and priorities, which requires a strong understanding of the ISO 17025 accreditation, Guidelines for the Validation of Chemical Methods in Food, Feed, Cosmetics and Veterinary Products and per local Standard Operating Procedure. Performs verifications and validations of new chemistry methods.

Serves as a technical expert and scientific advisor in the specialty area of chemistry instrumentation and analytical software applications. The incumbent is responsible for addressing methodology problems encountered by other ORA field professionals. Troubleshoots instrumentation issues and problems that arise when evaluating data such as contamination control, poor sensitively, reasons for Quality Control failures, incomplete extraction, and other method performance problems. Participates in internal planning to make recommendations to management related to the future needs of the laboratory such as new analytical instruments and methods of analysis.

May be required to organize and present seminars and training sessions on specialized chemistry instrumentation and technical areas specifically related to analytical methods and research. As needs dictate, training may be given at any FDA location. Training may be provided to visiting foreign scientists, other Federal, state, and local government agencies as well as FDA personnel. May participate in interagency programs in training and quality assurance that involves area of specialty. Writes professional reports of findings and offers them for publication in recognized scientific journals and in-house bulletins. When requested, reviews methods to be used by the agency in the United States Pharmacopoeia and other compendia, and the scientific papers offered by other scientists for publication and judges the level of their contribution to present knowledge in specialty area and their suitability for publication. Testifies in court as an expert witness in specialty field.

Supervisory Responsibilities: This is not a supervisory role.

How to Apply

Applications will be accepted by all qualified applicants. Applicants must submit a letter of interest addressing experience in the major duties and responsibilities of the position, a detailed current resume, SF-50 (redacted for SSN and birth year, for federal employees only) and college transcript(s) (with foreign credentials evaluation, if applicable) to the ORA Executive Recruitment and Scientific Staffing Committee: ORAExecutiveandScientificRecruitment@fda.hhs.gov. Applications will be accepted through March 18, 2024. Applicants must reference 4-Chemist-Irvine in the email subject line.

Announcement Contact

For questions regarding this Title 21 position, please contact: ORAExecutiveandScientificRecruitment@fda.hhs.gov

The Department of Health and Human Services is an equal opportunity employer with a smoke-free environment.

FDA is an equal opportunity employer.