This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Drug Evaluation Research (CDER), Office of Compliance (OC), Office of Manufacturing Quality (OMQ) located in Silver Spring, MD.Learn more about this agency
This position is an Interdisciplinary Scientist position that may be filled as a Biologist, GS-0401, a Microbiologist, GS-0403 or Chemist, GS-1320.
NOTE: It is anticipated that there will be significant interest in this announcement. As a result, this announcement will close at 11:59 p.m. ET on the date of receipt of the 100th application or at 11:59 p.m. ET on Tuesday, January 9, 2018 (whichever comes first), as documents will not be accepted after the vacancy closes.
Who May Apply: This is open to current permanent employees of the Department of Health and Human Services (DHHS), only. Current Department of Health and Human Services (DHHS) employees under a Schedule A appointment are also eligible for consideration. Displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) eligibles within the local commuting area; eligibles within the local commuting area. PHS Commission Corps Officers may apply.
PHS Commissioned Corps Officers interested in performing duties of this position as a Commissioned Officer may apply for consideration. Candidates will be referred to the Selecting Official for consideration on a Commissioned Corps assignment but not as candidates for a career-conditional/career appointment under Title 5.
You must submit documentation to verify your eligibility to apply for this vacancy. For most applicants, an SF-50 will be required. However, if you are applying based as a Veteran, person with a disability, or a displaced former employee, you will be required to provide other supporting documents as applicable. See the Required Documents section for more details.
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.
Additional selections may be made within the same geographical area FDA-wide.
As a Interdisciplinary Scientist, you will have the following responsibilities;
- Perform administrative and scientific regulatory review for Good Manufacturing Practices (GMPs) and/or Biological License Applications (BLAs), New Drug Application (NDA), Abbreviated New Drug Applications (ANDA's) supplements and amendments.
- Within scientific area of expertise and assigned products area, provides authoritative advice and guidance to manufacturers, consumers, investigations, other reviewers, and agency committees, counterparts in other agencies and centers on GMPs including process validation, environmental issues and facility design.
- Participate as the lead inspector or GMP expert on establishment pre-approval or post-approval inspections.
- Meet with representatives of the regulatory industry and other sponsors of therapeutic products about potential product and establishment issues, or to discuss scientific or regulatory issues involved in new drug and biological applications.
- Serve as a member of committee for GMPs and/or biological license applications/supplements/amendments, and a committee member or chair for GMPs and/or BLAs supplements.
Who May Apply
This job is open to…Agency Employees Only - Appearing on USAJOBS
This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/487289100. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.