Research Scientist (Telework Eligible)

This position is being filled under an excepted 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 the 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

View full vacancy announcement here: https://www.fda.gov/media/165040/download

Introduction

The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.

The Center for Drug Evaluation and Research (CDER) is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over-

the-counter drugs (OTC). CDER’s drug regulatory responsibilities include premarket review of new drugs and generic drugs; maintenance of the OTC drug monograph system; monitoring of all marketed drug safety and promotion activities; review, monitoring, and enforcement of drug quality during the entire drug life cycle; and ensuring drug products in the market comply with the law.

The Office of Pharmaceutical Quality (OPQ) oversees and coordinates the overall regulation of human pharmaceutical quality within CDER, including submission review, manufacturing facility assessment, and surveillance of the quality of marketed pharmaceutical products.

The Office of Biotechnology Products (OBP) serves as the OPQ’s centralized regulatory resource on biotechnology drug assessment and research. OBP regulates biological products and biosimilar biological products and supports OPQ in the overall regulation of human pharmaceutical quality.

Duties/Responsibilities

As a Research Scientist, the incumbent serves on multi-disciplinary scientific teams and provides technical guidance in research activities designed to resolve specific scientific issues to support regulatory assessment, policy development, and decisions.

• Reviews and evaluates a broad range of biopharmaceutical and chemical data which are received as part of clinical and analytical documents.

• Provides authoritative review or coordination of a review of important precedent setting scientific issues which establish Agency policy for subsequent reviews.

• Conducts characterization and bioequivalence assessment of complex drug substances.

• Develops advanced manufacturing approaches for drug substances and drug products including understanding of excipients effects, design of experiments, control strategies, and modeling as well as immunogenicity risk assessment and mitigation.

Supervisory Responsibilities: n/a

How to Apply

All qualified candidates should submit their resume with cover letter and unofficial transcripts (if you have foreign transcripts please submit a course-by-course foreign evaluation from an accredited company (NACES or AICE) by February 14, 2023. Candidate resumes may be shared with hiring officials within CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”.

Please reference Job Reference ID: OBP Research Scientist – Apply to HireVue – OBP: Research Scientist

How You Will Be Evaluated

Candidates may be evaluated based on an interview, review of requested work samples, writing samples, most recent performance evaluation(s), professional references, results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration.

Announcement Contact

For questions regarding this Cures position, please contact OPQOBPRecruitment@fda.hhs.gov.

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

FDA is an equal opportunity employer.