This Direct-Hire position is in the Food and Drug Administration (FDA) and is located in the Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) which serves to support the agency's mission and program activities, reviewing analytical and/or nonclinical issues in the biological sciences.

Duties

Performs regulatory reviews that includes advising or leading discussions on area-specific clinical issues, good laboratory practices (GLP), current good manufacturing practices (cGMP), or other aspects of Quality Assurance/Quality Control (QA/QC). Provides formal instruction to inspectors of manufacturing and testing establishments, as provided under the Public Health Service Act and the Federal Food, Drug and Cosmetic Act, and implemented with a biologics team. Responds to inquiries from manufacturers of biologics establishments regarding the safety of biologics, through direct contact, preparing the review and evaluation of written requests. Presents Center and/or Agency concerns or positions to committees and/or other regulatory meetings, working groups, etc., concerning questions arising with regard to product safety, purity and/or potency. Assures that scientific reviews are incorporated into a final assessment, addressing all key aspects of products (including proposed clinical trials and in-process testing to assure safety, efficacy, purity and potency of products). Identify and analyze areas for which new policies must be formulated, to have a broad knowledge base, and the ability to evaluate complex regulatory issues to meet the increased volume and variety in regulated products. Require thorough knowledge of current literature, recent scientific discoveries, and novel technologies and testing platforms in the area of biologics. Serves as a leading scientist of a review team that must integrate the review analysis in order to draw valid conclusions.

Requirements

• 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 Biological Reviewer falls under the 0401 occupational series. To qualify for this position at grade GS-13, you must meet Time-in-Grade requirements by 11:59 pm EST on 03/06/2024. Basic Requirements A. Degree: 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. Specialized Experience for GS-13: You must possess one (1) year of specialized experience, equivalent to at least the GS-12 grade level in the Federal service to include: (1) Reviewing regulatory applications for manufacturing of biologics, drugs, or biological devices; OR (2) Employs knowledge of laws, regulations, policies, or guidance to evaluate nonclinical studies for investigational products; OR (3) Advising on the design of nonclinical studies for biological products. All qualification requirements must be met by 11:59 pm (Eastern Time) on 03/06/2024. 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://my.usajobs.gov/Account/Login, 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

THIS POSITION HAS A POSITIVE EDUCATION REQUIREMENT.

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 U.S. Department of Education website for Foreign Education Evaluation

Contacts

• Address FDA Center for Biologics Evaluation and Research 10903 New Hampshire Ave Silver Spring, MD 20993 US
• Name: FDA Applicant Help Desk
• Phone: 866-807-3742
• Email: [email protected]