Biologist, GS-0401-13

Vacancy ID: 745734   Announcement Number: HHS-FDA-CVM-DE-12-745734   USAJOBS Control Number: 326972400

Occupational/Assessment Questions:

1. Please select the statement that indicates how you meet the basic requirement for a GS-0401 Biologist position. (You must submit transcripts to verify your education.)

A. I have successfully completed a four year course of study in an accredited college or university leading to a Bachelor's or higher degree in biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position.
B. I possess education, which included courses equivalent to a major, as shown in A above, plus appropriate experience or additional education. Combined education and experience must be comparable to the knowledge, skills, and abilities normally acquired through the successful completion of a full 4-year course of study with a major in the fields listed above.
C. My education and/or experience is not described in the statement above.

2. Please select the statement that describes how you meet the specialized experience for this position at the GS-13 grade level.

A. I have at least one full year of specialized experience, equivalent to the GS-12 grade level in the Federal service, reviewing and analyzing clinical and non-clinical, pharmacological and biological studies to assess the safety of animal drugs, including those used in aquaculture; coordinating with team members to manage a research/review process; implementing bio-related methods and study designs, such as protocols, scientific data development, and sampling methods to gather and analyze biological data; and providing technical guidance on scientific and regulatory standards for quality assurance and quality control of the animal food, drug, and device industry, including Good Manufacturing/Laboratory Practice requirements.
B. My experience is not described in the statement above.

For each of the items below, select the one statement that most accurately describes your experience and capability using the scale below.

A- I have no experience in performing this work behavior.
B- I have limited experience in performing this work behavior. I have had exposure to this work behavior but would require additional guidance, instruction, or experience to perform it at a proficient level.
C- I have experience performing this work behavior across routine or predictable situations with minimal supervision or guidance.
D- I have performed this work behavior independently across a wide range of situations. I have assisted others in carrying out this work behavior. I seek guidance in carrying out this work behavior only in unusually complex situations.
E- I am considered an expert in carrying out this work behavior. I advise and instruct others in carrying out this work behavior on a regular basis. I am consulted by my colleagues and/or superiors to carry out this work behavior in unusually complex situations.

3. Provide guidance to staff and other Biologist on areas related to biology, including the anatomy and physiology of a variety of companion or food animal species.

4. Evaluate common interactions between animals, chemical entities (e.g., drugs, foods, metabolites), and the environment.

5. Evaluate the metabolism, absorption, distribution and elimination of chemical entity from tissues and organs.

6. Request clinical and non-clinical data (e.g., in vitro) and histories of affected animals from scientists for review.

7. Prepare reports and/or manuscripts for publication in scientific literature and within an organization.

8. Conduct mathematical modeling and statistical methods to analyze research results of biological studies.

9. Review the accuracy and validity of the experimental design used to develop and collect data.

10. Study various factors that may lead to the development of safety and efficacy standards for drugs, foods, and devices.

11. Monitor post-marketing reports, such as drug experience, feed ingredients, and devices to request additional information, tests, and data, as appropriate.

12. Set short-term priorities scheduling the completion of research/review program work.

13. Coordinate with senior management officials in the development of research program goals.

14. Research computer-based databases and scientific literature (e.g., manuals, journal articles, other technical references) pertinent to the investigation of drug review issues.

15. Monitor the progress and compliance of research/review activities with applicable laws, regulations, and policies, including Good Manufacturing/Laboratory Practices.

16. Present decisions and technical findings to officials of pharmaceutical, food/feed, and device industry.

17. Develop descriptions of data requirements, such as study designs and guidance documents for research.

18. Facilitate discussions between scientists, academia, and industry representatives in the exchange of information and research findings.

19. Provide guidance on applicable laws (e.g., Food, Drug and Cosmetic Act; National Environmental Policy Act regulations and policies) as they pertain to the review and approval process for animal drug and feed.

20. Provide scientific advice on potential health, safety, and toxicity of various products.