About FDA

Interdisciplinary Scientist

Description of DutiesInterdisciplinary Scientist

  • 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.

Qualifications

Applicants must demonstrate that they meet any of the basic requirements (I, II, and/or III) AND the specialized experience requirement listed below:

I. Basic Requirements for Biologist: Possess a degree in biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position; OR Possess a combination of education and experience -- Courses equivalent to a major, as shown above, plus appropriate experience or additional education (must submit transcript at time of application submittal).

II. Basic requirements for Microbiologist: Possess a degree in microbiology; or biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent; OR Possess a combination of education and experience -- courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown above, plus appropriate experience or additional education (must submit transcript showing coursework at time of application submittal).

 III. Basic Requirements for Chemist: Possess a degree in physical sciences, life sciences, or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics; OR  Possess a combination of education and experience -- course work equivalent to a major as shown in A above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education (must submit transcript showing coursework at time of application submittal).

AND

Specialized Experience Requirements: 

GS-12: Applicants must have one year of specialized experience, equivalent to the GS-11 level of responsibility in the Federal service that includes: reviewing and evaluating drug applications, amendments, and supplements to ensure compliance with Current Good Manufacturing Practices (CGMPs); providing advice and guidance on policies and regulations regarding the manufacturing and distribution of new drug  products; interpreting CGMP data of drug and/or biologic applications; and maintaining working relationships with regulated industry representatives and other sponsors.

GS-13: Applicants must have one year of specialized experience, equivalent to the GS-12 level in the Federal service that includes: leading the review and evaluation of drug applications, amendments, and supplements to ensure compliance with CGMPs; providing advice and guidance on policies and regulations regarding the manufacturing and distribution of drug products; recommending modifications, approval, or disapproval of new drug or related applications; and collaborating with regulated industry representatives and other sponsors to discuss and/or resolve manufacturing issues.

Grade (Salary) Level

Federal General Schedule (GS) grade levels at which Interdisciplinary Scientist positions are commonly filled are:

  • GS-12 through 13 at the headquarters level

Geographical Locations

Interdisciplinary Scientists are located at HQ (suburban Washington, D.C.) and in facilities throughout the U.S.

Page Last Updated: 12/01/2014
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