Biologist

Summary

This Direct-Hire position is in the Food and Drug Administration and is located in the Center for Veterinary Medicine (CVM), Office of New Animal Product Evaluation (ONAPE) which is to protect human and animal health. CVM has regulatory authority over food, food additives, drugs, and devices for animals..

Annual leave for non-federal service incentive may be authorized.

Learn more about this agency

Duties

• Applies biological knowledge and experience to the assessment of new or marketed products reviewed by the Division of Biotechnology, including intentional genomic alterations in animals, to assure their safety and effectiveness.
• Analyzes results of experiments to determine whether data generated is accurate and valid.
• Synthesizes scientific findings across analyses to provide conclusions and recommendations.
• Determines and/or utilizes appropriate analytical methods to analyze research data, including for the characterization of intentional alterations introduced into animal genomes (e.g., via genetic engineering or genome editing).
• Serves as an expert technical consultant and advisor to CVM staff and stakeholders regarding biotechnology products (e.g., product characterization, target animal safety, user safety, comparability, durability, effectiveness).
• Collaborates with and advises others on biological issues related to animal drugs, foods, devices, laws, regulations, and policies as well as scientific research and industry developments in biology and related fields.
  
  

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.
• You may be required to serve a one (1) year probationary period.
• This is a Direct-Hire advertisement: Veterans Preference is not applicable to this advertisement. Learn more about Direct-Hire at https://www.opm.gov/policy-data-oversight/hiring-information/competitive-hiring/#url=directhire.
• If you were born male, after, December 31st 1959, you must be registered with the Selective Service System, or have an approved exemption. Learn more at www.SSS.gov.
• Selectee for this position may be required to file a Confidential Financial Disclosure Report (OGE 450) and may require the selectee to obtain clearance from the FDA Division of Ethics and Integrity before a final offer can be made.
  
  

Qualifications

The position of Biologist falls under the 0401 occupational series. To qualify for this position at grade GS-12/13, you must meet all requirements by 11:59 pm EST on 01/29/2025.

Basic Requirements

• Have successfully completed a four (4) year degree or higher in biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position.
  
  

OR

• 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.

GS-12: You must have 1 year of specialized experience equivalent to at least the GS-11, in the Federal service, which includes: reviewing and analyzing scientific data using biology related methods and study designs; and providing analytical interpretations, conclusions, or recommendations on regulatory and compliance issues in the biology field related to products of biotechnology.

GS-13: You must have 1 year of specialized experience equivalent to at least the GS-12, in the Federal service, which includes conducting, reviewing, or analyzing biological studies; participating in the development of biology-related guidance and policy documents for regulatory compliance; and advising and providing recommendations on biological issues related to products of biotechnology.

All qualification requirements must be met by 11:59 pm (Eastern Time) on 01/29/2025. 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, https://secure.login.gov/ , 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.

Education

Transcripts

Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.

Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.

Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.

See the Application Manager Documentation for tips on submitting your paper-based documents.

FOREIGN EDUCATION

Applicants using part, or all of their education completed outside of the U.S. to meet the qualification requirements, must have their foreign education evaluated by an accredited organization to ensure that the foreign education is comparable to education received in accredited educational institutions in the U.S. We will only accept the completed foreign credential evaluation.

To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery. Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.

Applicants Can Request An Evaluation From a Member Organization Of One Of The Two National Associations Of Credential Evaluation Services Listed Below

• National Association of Credential Evaluation Services (NACES)
• Association of International Credentials Evaluators (AICE)
  
  

Credential evaluations are not free, and applicants are responsible for the cost of the selected service.

For more information about this requirement, please visit the https://sites.ed.gov/international/recognition-of-foreign-qualifications/

Additional Information

For some advertisements, the Food & Drug Administration receives hundreds, even thousands, of applications from job-seekers. Because of this high level of interest in positions with the FDA, the agency reserves the option of setting an application number limit.

When an application limit is set, USAJOBS will close the vacancy at 11:59 pm Eastern Time on either:

• the day the limit is reached,
  
  

-OR-

• the pre-defined closing date of 01/29/2025, whichever comes first.
  
  

If the limit is reached before 11:59 pm ET, all applications in excess of the limit will continue to be accepted until 11:59 pm ET.

The application limit, if applicable, for this advertisement is: 200

For more information about announcement closing, see: https://www.usajobs.gov/Help/faq/job-announcement/expiration/

Additional Conditions Of Employment

• Pre-employment physical required: No
• Drug testing required: No
• License required: NO
• Mobility agreement required: No
• Immunization required: No
• Bargaining Unit: Yes, 3591
• Telework eligible position: Telework is at the discretion of the supervisor.
• Financial disclosure statement, OGE-450, required: Please be advised that this position may be subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position. For more information please visit https://www.fda.gov/about-fda/jobs-and-training-fda/ethics .
  
  

Additional Information

• Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
• If you are serving, or have served in the last 5 years (from 01/29/2025) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. See https://www.opm.gov/frequently-asked-questions/political-appointees-and-career-civil-service-positions-faq/ for more.
  
  

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A career with the U.S. government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. Opens in a new window Learn more about federal benefits .

Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent. Contact the hiring agency for more information on the specific benefits offered.

How You Will Be Evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

All requirements must be met by the closing date of this announcement (01/29/2025); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.

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 Office of Personnel Management direct hire guidelines. Note: Volunteer experience can also be used as qualifying experience.

Once the job opportunity announcement closes (at 11:59 pm Eastern Time on 01/29/2025), 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 USAJOBS Career Transition Assistance Site .

Please follow all instructions carefully. Errors or omissions may affect your eligibility.