Job Overview

Summary

Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.

As a Chemist in the Office of Pharmaceutical Science (OPS), Center for Drug Evaluation and Research (CDER), Office of Medical Products and Tobacco, Food and Drug Administration (FDA), you will evaluate drug substance synthesis, drug product formulation design, or drug product manufacturing processes and associated control strategies, including analytical procedures used to ensure the safety, efficacy and quality of drugs produced by foreign and domestic producers.

 

This announcement is open continuous for 90 days with the following cut-off dates:

  • February 23, 2014
  • March 23, 2014
  • April 23, 2014

 

This vacancy is also being announced concurrently with vacancy announcement FDA-CDER-14-DE-1032906DG under delegated examining procedures.  Please review that announcement to see if you are eligible for consideration under delegated examining procedures.  NOTE:  Applicants must apply separately for each announcement in order to be considered.

 

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement under noncompetitive merit promotion procedures. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.

 

This job opportunity announcement may be used FDA-wide to fill additional vacancies within the same geographical location.

Duties

  • Review and evaluate chemistry, formulation, manufacturing, controls, and biopharmaceutics including drug releases, technical aspects of labeling and environmental impact information submitted in various drug applications and supplements (i.e., BLAs, NDAs, ANDAs, and INDs).
  • Evaluate the adequacy of testing and control of container closure systems, starting and intermediate materials, reagents, and solvents.
  • Establish clinically relevant quality standards to ensure its clinical performance for approval to market and for the entire lifecycle of the drug product.
  • Assess the adequacy of pharmaceutical manufacturing; and, products usability and acceptability to the patient.
  • Evaluate the adequacy of analytical methods and validation reports used during synthesis, characterization, manufacture, release and stability testing of drug substances and drug products.
  • Communicate review outcomes including any identified deficiencies or issues, established policy and any further requests through oral and/or written communication. 

Travel Required

  • Not Required

Relocation Authorized

  • No