Enter your Social Security Number in the space indicated. Your Social Security Number is requested under the authority of Executive Order 9397 to uniquely identify your records from those of other applicants who may have the same name. As allowed by law or Presidential directive, your Social Security Number is used to seek information about you from employers, schools, banks and others who may know you. Providing your Social Security Number is voluntary, however we can not process your application without it.
Are you an ICTAP Eligible?
For information on how to apply as an ICTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ictap. To be well-qualified and exercise selection priority for this vacancy, displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position.
Are you eligible for Indian preference as defined by the Department of the Interior (DOI) and as evidenced by appropriate Bureau of Indian Affairs (BIA) authorized certification?
Are you eligible for preference based on being a Public Law 94-437 Indian Health Service Scholarship recipient? For more information, please click here.
Are you eligible for the Federal Employment Program for Persons with Disabilities? (For information on Schedule A appointments, see the OPM website.)
Are you a PHS Commissioned Officer (This includes active duty officers, inactive reserve officers, and applicants who have been approved for commissioning in the USPHS Commissioned Corps)?
Are you eligible for noncompetitive appointment?
This includes applicants who are eligible for special or noncompetitive appointment authorities such as 30% or more compensable disabled veterans, persons with disabilities and PHS Commissioned Corps Officers. This also includes applicants who meet the qualifications for this position and who have previously held, or currently hold, a Federal position at the grade of this position.
Enter the lowest grade level that you will accept for this position. The lowest grade for this position is 14.
If you are a male at least 18 years of age, born after December 31, 1959, have you registered with the Selective Service System?
Select/enter at least one occupational specialty. The specialty code for this position is:
Select/enter at least one geographic location in which you are interested and will accept employment. The location code for this position is:
1. For the GS-14 grade level, applicants must have 52 weeks in a non-temporary appointment at the GS-13 grade level. This year of experience must be equivalent to at least the next lower grade level that demonstrated the experience with the licensing process for biological products and the associated user with fee regulations in the Federal service. Specialized experience is experience that has equipped the applicant with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. Specialized experience is defined as experience such as using indepth knowledge of the licensing process for biological products and the associated user fee regulations to perform work, and leading a staff, including assigning and evaluating work.A. I have at least one year of specialized experience that has equipped me with the particular knowledge, skills, and abilities to successfully perform the duties of the position. This experience is related to the work of the position and equivalent to at least the GS-13 level in the Federal service as described in the vacancy announcement.
2. Are you a current Federal employee with career or career-conditional status in the competitive service within Food Drug Administration, Displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP), and PHS Commissioned Corps Officer interested in performing the duties of this position?A. Yes
For each task in the following group, choose the statement from the list below that best describes your experience and/or training.A- I have not had education, training or experience in performing this task.
3. Reviews work of subordinate staff on a regular and recurring basis.
4. Develops performance ratings for subordinate staff members.
5. Plans work to be performed by staff, sets and adjust short term priorities, and prepare schedules for the completion of work.
6. Responsible for the overall review and approval process for Biologics License Applications (BLA) and amendments for biological products submitted to CBER.
7. Develops policy and procedures governing the standards for the review and evaluation of establishments producing biological products.
8. Analyzes inquires and obtains salient information from technical and legal sources, consults appropriate personnel within FDA and draws conclusions based on findings and recommends a specific reply to the inquiry.
9. Serves as the principal advisor to the Division Director on biological product regulatory concerns related to manufacturing process review and compliance matters.
10. Serves as chairperson or member of licensing committees for biologics license supplements and as member of biological product applications.
11. Serves as the Center's expert providing authoritative advice and guidance to manufacturers, consumers, Agency committees, other government agencies and Center staff on current good Manufacturing Practice Regulations, process validation, environmental issues and facility design.