Engineering Careers at CDER
Work for the FDA's Center for Drug Evaluation and Research (CDER)
What do Engineers do at CDER?
The Center hires Materials Engineers, Mechanical Engineers, Bioengineers/Biomedical Engineers, and Chemical Engineers. The duties of an Engineer differ by office. Opportunities may include:
- Serving on multi-disciplinary scientific teams providing technical guidance to resolve specific scientific issues to support regulatory assessment, policy development, and quality surveillance.
- Performing research to support the development of scientific standards on the composition, quality, safety, and effectiveness of drug products, including research to facilitate the assessment and adoption of emerging technologies.
- Providing advice concerning research activities that include the characterization of drug substances and drug products, their formulation and manufacturing processes as related to drug delivery, in vitro drug release, and in vivo drug performance.
- Advising on product quality research focused on industrial pharmacy, physical chemistry, medicinal chemistry, synthetic organic chemistry, and/or macromolecular chemistry that applies to pharmaceutics; excipients function and characterization; kinetics and mechanisms of the chemical instability of drugs; and kinetics and mechanism of the physical instability of dispersed and colloidal drug formulations.
- Conducting system analysis using advanced data analysis or other specialized techniques to assess and mitigate product design and manufacturing risks related to ensuring pharmaceutical product quality.
- Reviewing and evaluating a broad range of biopharmaceutical and chemical data that are related to sections of submissions pertaining to the chemistry, manufacturing processes, and controls in a variety of drug applications, including but not limited to Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs).
- Participating in the inspection of pharmaceutical manufacturing facilities applying detailed and diversified knowledge in engineering to develop standards for the analysis and evaluation of the control of production, service operations, and systems.
Related positions include:
- Consumer Safety Officer
- Pharmaceutical Scientist
- Research Scientist
How can I find an Engineer position at CDER?
Available CDER positions are listed on USAJOBS and under the FDA 21st Century Cures Act Hiring Authority.
1. Search USAJOBS by Keyword: CDER. You can filter your search by:
Agency
- Food and Drug Administration
Series
- 0801 - General Engineering
- 0806 - Materials Engineering
- 0830 - Mechanical Engineering
- 0858 - Bioengineering and Biomedical Engineering
- 0893 - Chemical Engineering
2. Visit We Are Hiring | FDA to find a current listing of opportunities utilizing the FDA 21st Century Cures Act Hiring Authority.
Where can I learn more about careers at the FDA?
For general information on working at the FDA and additional employment opportunities, visit: Jobs and Training at FDA.