Biologist

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:

21st Century Cures Act Information

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 mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over the counter (OTC) and prescription drugs, including biological therapeutics and generic drugs.

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

The Office of Policy for Pharmaceutical Quality (OPPQ) develops, implements, and updates science and risk-based policies and standards related to human drug product quality, including application assessment and inspection.

Duties/Responsibilities

As a Biologist, the incumbent provides advice and consultation to office management on program policy matters. Provides analysis and recommendations for effective development of OPQ policy and program strategies in the assessment of quality information submitted in Investigational New Drug applications (INDs), New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs) and assessed as part of Current Good Manufacturing Practice (CGMP) inspections to ensure the quality, safety, and efficacy of CDER-regulated products.

• Conducts cross-office policy working groups to facilitate timely and efficient policy decision-making and development of policy documents regarding the most complex issues.
• Serves as the primary author of draft policy documents addressing biology-related aspects of pharmaceutical quality.
• Participates in and/or leads quantitative and qualitative assessments of FDA policies and procedures related to pharmaceutical quality.
• Participates in and/or leads special projects or activities resulting from public health emergencies, Congressional interest or need, or from the actions of various quality disciplines.

Supervisory Responsibilities: N/A

How to Apply

All qualified candidates will submit their cover letter, resume, and transcripts to OPQOPPQRecruitment@fda.hhs.gov no later than May 17, 2024. The application period will either close on May 17, 2024, or after the Agency receive 100 resumes (applications). Once that number has been reached, the vacancy announcement will close.

A resume, not a CV, must be received. You can access the USA Jobs Resume Builder to assist with building your resume.

If you have foreign transcripts, please submit the foreign transcript course-by-course evaluation from an accredited company (NACES or AICE). 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: OPPQ Biologist in the subject line.

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 OPQOPPQRecruitment@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.