What do Chemists do at CDER?
The duties of a Chemist at CDER differ by office. Opportunities may include:
- Evaluating, identifying, and characterizing drug substance physical, chemical, biological, and mechanical properties and their impact on the drug product.
- Evaluating manufacturing processes and facilities used by foreign and domestic manufacturers of drug substances and/or products. Participating in the facility inspections related to the evaluation of manufacturing processes and controls and in support of pre-approval and CGMP inspections.
- Applying mastery of chemistry or biochemistry principles, practices, and procedures to determine the adequacy of testing for raw materials and intermediates; the control of manufacturing processes which leverage process analytical technology (PAT) and/or advanced manufacturing technology; and the testing of finished dosage forms.
- Advancing drug quality surveillance oversight by applying knowledge of supply chain data, drug recalls, imports/exports, marketed unapproved drugs, and product quality defects to develop tools used to identify samples for testing.
- Designing drug quality sampling and testing assignments.
- Conducting post-market quality-based assessments of sites and products by identifying, evaluating, and trending quality intelligence, such as root cause analyses and corrective and preventive actions, to execute response actions that mitigate urgent quality issues and risks associated with pharmaceutical formulation and manufacturing processes.
- Working with contract and budget staff to develop requisitions, contracts, and purchase orders to purchase and test drug samples.
- Collaborating with laboratory colleagues in CDER and the Office of Regulatory Affairs to develop and validate test methods and to verify violative test results.
Related positions include:
How can I find a Chemist position at CDER?
Available CDER positions are listed on USAJOBS and under the FDA 21st Century Cures Act Hiring Authority.
- Search USAJOBS by Keyword: CDER. You can filter your search by Agency: Food and Drug Administration and Series: 1320 - Chemistry.
- 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.