Pharmaceutical Scientist (Telework eligible)
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 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/164908/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 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 Biotechnology Products (OBP) protects and advances the public health through the assessment, regulation, and research of biological products and biosimilar biological products. OBP provides risk-based product quality assessments of biological products through characterization of both product and associated manufacturing processes. OBP’s labeling team assesses biological product labeling of the quality aspects.
Duties/Responsibilities
As the Pharmaceutical Scientist, the incumbent is responsible for reviewing and evaluating comprehensive information and data on chemistry, formulation, manufacturing (including process monitoring and controls), biopharmaceutics (including drug release), as well as technical aspects of labeling and environmental impact submitted in Biologic License Agreements (BLAs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and supplemental BLAs, NDAs, as appropriate. The pharmaceutical scientist performs a full range of duties in one or more of the specialized areas described below, primarily monitoring the lifecycle of both innovator or biological products and generic or biosimilar drugs through a team-based evaluation and assessment of supplements and annual reports using risk management practices.
- Formulates recommendations and decisions in areas where precedents and guidelines are inadequate, utilizing scientific background and understanding of broad legislation, policy statements, and regulatory program definitions.
- Identifies and analyzes the role of the manufacturing process variables affecting pharmaceutical intermediates and finished products for various manufacturing processes through scientific or engineered approaches.
- Evaluates the adequacy of sponsors data and results, including drug substance and drug product manufacturing, in-process, release, and stability data, using appropriate quantitative of mathematical approaches or tools.
- Participates in facility inspections related to the evaluation of manufacturing processes and controls and in support of pre-approval and continuous good manufacturing practices (cGMP) inspections.
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 10, 2023 to: OPQOBPRecruitment@fda.hhs.gov. 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 Pharmaceutical 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.