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.

This Interdisciplinary Scientist position will be filled as one of the following disciplines: 0401 Biologist, 0403 Microbiologist, or 1320 Chemist.

This position is located in the Center for Drug Evaluation and Research (CDER), Office of Compliance (OC). As an Interdisciplinary Scientist, you will be responsible for the evaluation of Current Good Manufacturing Practices (CGMPs) and/or drug applications and supplements associated with the manufacturing of human drug products.

This Job Opportunities Announcement will be open continuous for 90 days. The first cut-off date for applications received for consideration and/or referred to the hiring agency will be June 30, 2013. Subsequent referrals will be issued every 30 days until the announcement closes.

This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDER-MP-13-881057 under Merit Promotion procedures. Please review that announcement to see if you are eligible for consideration under Merit Promotion procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.

This job opportunity announcement may be used to fill additional vacancies.

Duties

  • Performs administrative and scientific regulatory review for Current Good Manufacturing Practices (CGMP) of products and facilities and/or with drug applications, supplements, and amendments.
  • Provides advice and guidance within assigned product area to manufacturers, consumers, investigators, other reviewers, and agency committees on CGMPs on process validation, environmental issues and/or facility design.
  • Evaluates facility design, operation, manufacturing and testing procedures to ensure compliance with CGMP regulations and policies. 
  • Meets with representatives of the regulated drug industry about potential product and establishment issues

    or scientific/regulatory issues involving drug products.