Biologist Job in Anywhere in the U.S. (remote job)

Vacancy No. FDA-CDRH-25-DH-12580002TB Department Food and Drug Administration
Salary $62,107.00 to $96,770.00 Grade 11 to 12
Perm/Temp Permanent FT/PT Full-time
Open Date 11/7/2024 Close Date 11/21/2024
Job Link Apply Online Who may apply Public
Locations:
Anywhere in the U.S. (remote job)


Summary

This Direct-Hire position is in Food and Drug Administration, located in the Center for Devices and Radiological Health. CDRH assures that patients and providers have access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH facilitates medical devices innovation by advancing regulatory science, providing industry with consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

This job is open to

Clarification from the agency

You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This is a direct hire authority announcement. Traditional federal rules regarding rating, ranking, and veterans' preference do not apply. This vacancy will also be used to clear CTAP/ICTAP. This announcement is also being advertised as a GS-13 under announcement number FDA-CDRH-25-DH-12580362TB.

Duties

  • This position is located in the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), in various areas/remote.
  • As a Biologist in CDRH you will:
  • Serve as a consultant and advisor to scientific and technical personnel, inside and outside the agency in a wide- ranging arena of scientific subject matters to include the field of medical devices and/or radiological product analysis and methods.
  • Determine safety and efficacy of routine and non-complex medical device products.
  • Work closely with senior level reviewers in the review and evaluation of scientific data submitted to the FDA by medical device industry to determine safety and efficacy of routine and non-complex medical device products.
  • Conduct and participate in discussions with industrial scientists and management officials regarding the development and regulation of medical devices.
  • Write and evaluate guidelines concerning the data required in submissions to the Agency for medical devices and their marketing.
  • Develop, modify, and evaluate guidelines concerning data required in device actions submitted to the Agency for medical devices.

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.

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 11/21/2024.

Basic Requirements: You must meet the basic education requirements for this position.
Degree: 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 above, plus appropriate experience or additional education.

AND

Minimum Qualifications:
Specialized Experience. 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.

For the GS-11 level, you must possess one full year (52 weeks) of specialized experience equivalent to at least the GS-09 level in the Federal service, which includes conducting studies and investigations concerning biological, chemical, and/or physical processes that affect biology resources; writing reports that provide recommendations for change or improvement; and analyze conventional issues.

OR

Have a Ph. D. or equivalent doctoral degree; or three full years of related progressively higher level graduate education leading to a Ph.D. degree.

For the GS-12 level, you must possess one full year (52 weeks) of specialized experience equivalent to at least the GS-11 level in the Federal service, which includes developing scientific experiments, conducting biological studies/investigations and following established experimental protocols or developing new experimental/ biologic protocols; interpreting scientific and regulatory directives to provide recommendations to other scientists; and preparing synopsis of data.

NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.

All qualification requirements must be met by 11:59 pm (Eastern Time) on 11/21/2024. 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,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:

  1. National Association of Credential Evaluation Services (NACES)
  2. 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:
(A) the day the limit is reached,
-OR-
(B) the pre-defined closing date of 11/21/2024, 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.
This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: 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.
  • Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS.
  • If you are serving, or have served in the last 5 years (from 11/21/2024) 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.

Benefits

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 windowLearn 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.

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 11/21/2024), 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 USAJOBS Career Transition Assistance Site.

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 USAJOBS Career Transition Assistance Site.

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 schools accredited by accrediting institutions recognized by the U.S. Department of Education.

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.

How to Apply

To apply for positions with the Food & Drug Administration, you must have a https://secure.login.gov/ account, and be signed in to that account, before you click "Apply Online". See the USAJOBS Help Site article "How does the application process work?" for more on this process. Additionally, you must provide a resume and any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement, 11/21/2024. We recommend that you start the application process early enough that you can complete and submit your application before this deadline.

Please note that you cannot submit documentation or make changes to your application after the close date.

If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: https://www.usajobs.gov/Help/how-to/. Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: https://www.usajobs.gov/Help/. FDA's Applicant Help Desk is not able to support USAJOBS-related issues.

The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or encounter any difficulty with the site, we recommend that you review the Applicant HELP Site at: https://help.usastaffing.gov/Apply/index.php?title=Applicant. This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you!

You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide reasonable accommodation to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please contact the Applicant Help Desk. Decisions on granting a reasonable accommodation will be made on a case-by-case basis.

If after reviewing the USAJOBS and Application Manager help sites, you're not able to find the answer to your question or concern, or if you wish to request a reasonable accommodation, please contact the FDA Applicant Help Desk at 866-807-3742, or e-mail QuickQuestions@fda.gov. The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays. If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 12580002 so that we may assist you faster.

Agency contact information

FDA Applicant Help Desk
Address
FDA Center for Devices and Radiological Health
10903 New Hampshire Ave
Silver Spring, MD 20993
US
Learn more about this agency

Next steps

HHS has a critical preparedness and response mission: HHS protects the American people from health threats, researches emerging diseases, and mobilizes public health programs with domestic and international partners. In support of this mission, HHS offers its employees the opportunity to volunteer to become Federal Civilian Detailees and contribute their unique skills through voluntary temporary assignments to humanitarian emergencies or Departmental priorities countering new and emerging health, safety, and security threats.

Federal agencies may request information regarding the vaccination status of selected applicants for the purposes of implementing other workplace safety protocols, such as protocols related to masking, physical distancing, testing, travel, and quarantine.
Once your application is submitted you will receive an acknowledgement email that your submission was successful. Qualified candidates will be referred to the hiring manager for further consideration and possible interview.

You will receive application status updates by email and on USAJOBS as the process unfolds.


Note: We cannot accept applications on behalf of Federal Agencies. Application instructions are listed within the Job Description.


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