Research Biologist


Vacancy ID: 809700   Announcement Number: HHS-FDA-CDER-DE-13-809700   USAJOBS Control Number: 334466800

Occupational/Assessment Questions:

1. Please select the one response that best supports how you meet the basic entry qualification requirements of education and/or experience for this position. You must provide transcripts from all educational institutions attended to verify your education. Failure to provide transcripts may cause you to lose consideration for the position.

A. I possess a four year degree in microbiology, biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology or 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. NOTE: You must submit a copy of your transcript.
B. I possess a combination of education and experience; i.e., courses equivalent to a major as shown in A above plus additional education or appropriate experience. NOTE: You must submit a copy of your transcript.
C. I do not possess the education and/or experience described above.

2. From the descriptions below, please choose the BEST answer that demonstrates your experience related to the GS-14 position.

A. I have one year of specialized experience, equivalent to the GS-13 in the Federal service, serving as a lead or principle investigator performing independent research and regulatory activities in the field of cancer biology, HER/ErbB family receptor-targeted therapies and therapeutic monoclonal antibodies primarily targeted to oncology indications; analyzing and evaluating scientific and regulatory elements of Investigational New Drug Applications (INDs), and related amendments; developing oral presentations on rapidly developing scientific areas; and performing research to address scientific issues associated with the safety, purity, and potency of monoclonal antibodies and related proteins for therapeutic and diagnostic applications.
B. My experience is not reflected in statement A 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. Analyze and evaluate scientific and regulatory elements of Investigational New Drug Applications (INDs), Biologics license applications and related amendments.

4. Interpret current scientific literature and advanced research technologies to the regulatory review of protein products.

5. Lead a research laboratory associated with scientific issues of safety, purity, and potency of monoclonal antibodies and related proteins for therapeutic and diagnostic applications.

6. Solve complex regulatory and research issues by designing creative solutions that reflect a multi-disciplinary approach to a problem.

7. Evaluate and adapt to rapid developments in the areas of novel drug design strategies such as antibody-drug conjugates and fusion proteins to address new challenges and changing priorities in protein manufacture and clinical use.

8. Conceptualize, design and supervise research projects.

9. Serve as an expert in the scientific and regulatory areas of molecular cancer biology, signal transduction, mechanisms of regulation of normal and cancer cell growth, migration, and protein trafficking for evaluation of drug activities.

10. Evaluate and interpret current scientific literature and advancing research technologies.

11. Prepare reports based on scientific findings relating to regulatory issues.

12. Develop scientific proposals for competitive intramural and external funding for research on cancer pathways, signal transduction, biomarkers and drug resistance.

13. Develop written skills sufficiently to prepare regulatory and scientific presentations.

14. Analyze data, interpret results and prepare manuscripts based on laboratory findings.

15. Oversee and train new personnel on regulatory review work as needed.

16. Organize and lead workshops or scientific meetings.

17. Present scientific information (e.g., data findings, observations, regulatory interpretations) to colleagues and management.

18. Develop oral presentations on rapidly developing scientific areas.