Biologist at U.S. Department of Health and Human Services (HHS Careers) in Rockville, MD

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.

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
A. 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

B. 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,, 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.

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 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 .

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

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 and Professional Licensure: If the position has an education or licensure 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 .

Veterans' Preference: Veterans must submit a DD-214 form (Certificate of Release or Discharge) that has the dates of service and discharge status and VA disability letter (if applicable).

Active Duty Members: To claim status under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011, submit written documentation from the armed forces that certifies the service member is expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
Parents of Deceased or Disabled Veterans: To claim preference, you must submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted.
Widow or Widower: To claim preference, you must submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted.
Spouse of a Living Veteran: To claim preference, you must submit a copy of the veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference, and Documentation of Veteran's Inability to Work Because of a Service-Connected Disability. Please follow the instructions in the SF-15 on required documentation to be submitted.

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.