What do Pharmaceutical Scientists do at CDER?
The duties of a Pharmaceutical Scientist differ by office. Opportunities may include:
- Reviewing and evaluating comprehensive quality information on chemistry, manufacturing (including process monitoring and controls), facilities, biopharmaceutics (including drug release), as well as technical aspects of labeling and environmental impact submitted in Investigational New Drug Applications (INDs), Biologic License Agreements (BLAs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), supplemental submissions to these application types, and Drug Master Files (DMFs), as appropriate.
- Performing 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:
- Utilizing scientific background and understanding of broad legislation, policy statements, and regulatory program definitions to formulate recommendations and drive risk-based decisions in precedent-setting situations.
- Identifying and analyzing the role of the manufacturing process variables affecting pharmaceutical intermediates and finished products for various manufacturing processes through scientific or engineered approaches.
- Evaluating the adequacy of sponsor data and results, including drug substance and drug product manufacturing, in-process, release, and stability data, using appropriate quantitative mathematical approaches or tools.
- Participating in facility inspections related to the evaluation of manufacturing processes and controls and in support of pre-approval, pre-license, post-approval, and current good manufacturing practices (CGMP) inspections.
Related positions include:
How can I find a Pharmaceutical Scientist 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:
- Food and Drug Administration
- 0401 - General Natural Resources Management And Biological Sciences
- 0660 - Pharmacist
- 1301 - General Physical Science
- 1320 - Chemistry
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.