Summary
This Direct-Hire position is in the Department of Health and Human Services (HHS) Food and Drug Administration (FDA), Center for Biologics Evaluation and Research(CBER), Office of Vaccines Research and Review (OVRR) which protects and enhances the public health by ensuring the availability of safe and effective vaccines, allergic extracts, and related products.
Only the first 150 candidates who apply to this announcement will be considered.
Duties
- Interprets, adapts and applies numerous guidelines, precedents and scientific principles and practices to determine the most appropriate and feasible design solutions as well as possible alternatives.
- Works with senior staff in the day-to-day operation of the laboratory, including coordinating research projects and personnel, and ensuring availability of equipment and supplies.
- Responsible for utilizing biological knowledge and experience to inform scientific and regulatory decisions regarding the safety and effectiveness of biological products.
- Prepares scientific information related to immunoassays and other assays to measure potency of allergenic products.
- Practices and enforces safe laboratory practices and hazardous materials handling; follows established safety guidelines and disseminates safety standards to all staff.
- Utilizes biological knowledge and experience to recommend scientific and regulatory decisions regarding the safety and effectiveness of biological products.
Requirements
Conditions of Employment
- Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
- Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
- Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
- FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
- Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
- Selective Service Registration: All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Visit www.SSS.gov for more info.
- You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.
Qualifications
The position of Biologist falls under the 0401 occupational series. To qualify for this position at grade GS-11/12, you must meet all requirements by 11:59 pm EST on 11/25/2024.Basic Requirements
(A) Degree: biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position.
OR (B) A combination of education and experience: Courses equivalent to a major, as shown in A above, plus appropriate experience or additional education.
NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Minimum Qualifications:
Specialized experience is experience that 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. The specialized experience must demonstrate one year of full-time work experience , or the equivalent if part-time (for example, an employee working 20 hours per week for a 12-month period should be credited with 6 months of experience.) Experience may have been obtained in either the federal service or its equivalent with state or local government, the private sector, or nongovernmental organizations.
Specialized Experience for GS-11: Applicants must have at least one (1) year of specialized experience, equivalent to the GS-09 level in the Federal service to include: (1) Reviews numerous guidelines, precedents and scientific principles and practices to recommend the most appropriate and feasible design solutions; OR 2) Works with senior staff in the day-to-day operation of the laboratory, including coordinating research projects; OR 3) Keeps abreast of the pertinent literature and incorporates appropriate concepts and techniques into regulatory research activities and experiments.
Specialized Experience for GS-12: Applicants must have at least one (1) year of specialized experience, equivalent to the GS-11 level in the Federal service to include: (1) Compares and contrasts current policies with future needs in formulating appropriate strategies for addressing problems, developing timetables to ensure prompt action and institute efficient follow up procedures; OR 2) Practices and enforces safe laboratory practices and hazardous materials handling; follows established safety guidelines and disseminates safety standards to all staff; OR 3) Serves as a Biologist responsible for maintaining and replacing reference reagents, developing new assays intended to assure quality and potency of allergenic products, maintain quality standards and the laboratory's certification from the International Organization for Standardization (ISO).
All qualification requirements must be met by 11:59 pm (Eastern Time) on 11/25/2024. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities. You must continue to meet all requirements through the hiring process.
You may be asked to provide additional information at a later time. All interview requests and selection decisions are at the full discretion of the hiring office.
NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date . To verify your application is complete, log into your USAJOBS account,, select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process.
IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume.
Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.
How You Will Be Evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
This is a direct hire announcement. Traditional rating and ranking of applications, and veterans' preference does not apply to this vacancy. We will evaluate you against the basic qualifications. Qualified applicants will be referred for consideration in accordance with the Note: Volunteer experience can also be used as qualifying experience.
Once the job opportunity announcement closes (at 11:59 pm Eastern Time on 11/25/2024), a review of your résumé and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for Federal employment, and then whether you are qualified for this particular position. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible.
If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration. These assessment methods/tools may also be listed under Key Requirements.
Interagency / Career Transition Assistance Program (I/CTAP): Well-Qualified is defined as an applicant who meets the qualification standards and eligibility requirements for the position, including minimum educational and experience requirements; any medical qualifications and suitability; is able to perform the essential duties of the position, with or without reasonable accommodation; meets any applicable selective placement factors for the position (such as the ability to speak a specific language or any other factor required immediately upon hire); and is able to satisfactorily perform the duties of the position upon entry. Learn more on the .
Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Basis of Rating: Basis of Rating: Best qualified competitive merit promotion candidates and all qualified noncompetitive candidates will be referred to the hiring manager for consideration.
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of these competencies.
- Research
- Manages Resources
- Manages and Organizes Information
Required Documents
Resume: At a minimum, your resume should list the position title, employer name, start and end dates (including month and year), salary (or grade and step), hours worked per week, and a list of duties performed or accomplishments, for EACH position listed. A CV (curriculum vitae) may not contain enough information to meet these resume requirements.
Transcripts: If the position has an education requirement or you are qualifying based on education, unofficial transcripts or a list of courses and a copy of your professional license must be provided. See the Qualifications and Education Requirements section of this announcement.
I/CTAP:
If you are a current/former Federal employee who is surplus or displaced, please submit supporting documentation (e.g., a Certification of Expected Separation, separation notice, RIF separation notice, notice of proposed removal, SF-50 for RIF separation, etc.) and your most recent performance appraisal. To be selected under I/CTAP, you must be found well-qualified for this position and have a current performance appraisal rating of at least "Fully Successful". See the How You Will Be Evaluated section for the agency's definition of well-qualified. Learn more on the .
If you are relying on your education to meet qualification requirements:
Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from .
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.