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    Duties

    Summary

    Become a part of the Department that touches the lives of every American! At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere. It is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans.

    This position is located in the Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) in the following Offices:
    Office of Lifecycle Drug Product (OLDP); Office of New Drug Products (ONDP); Office of Process and Facilities (OPF).


    Who May Apply: This is an internal agency vacancy which is open to current FDA employees and PHS Commissioned Officers only.

    PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.

    You must verify that you are a current FDA employee or PHS Commissioned Officer, therefore, your most recent SF-50 will be required.

    Failure to submit the required documents will result in loss of consideration. Examples of required documents are: Most recent Promotion or With-in-Grade Increase SF-50 and the SF-50 that reflects the highest grade you held, transcripts and other required supporting documents.

    First time supervisors/managers are required to serve a one year supervisor/managerial probationary period.

    Additional selections may be made within the same geographical area FDA-wide.

    Learn more about this agency

    Responsibilities

    As a Supervisory Interdisciplinary Scientist, you will have the following responsibilities:

    • Plans, manages, organizes, and directs regulatory review operations, programs, functions, and activities of the Branch. Addresses and solves unusual and often precedent-setting problems associate with the Branch's regulatory reviews activities.
    • Provides authoritative advice and assessments of the impact of actual and proposed actions on the program segment, functions, and activities of the Branch.
    • Identifies new scientific initiatives and innovation opportunities in order to prevent poor quality products and/or manufacturing stoppage.
    • Prepares and delivers briefing to Center Director and other internal stakeholders. Collaborates with the stakeholders (e.g. OPQ, CDER, ORA, CDRH) on strategies pertaining to the overall assessment of submissions.
    • Obtains resource and identifies strategic objectives for the organization.
    • Directs implementation of new laws and regulations that affect the mission of the Division and have the potential to impact changes in FDA guidance, processes, and procedures.
    • Keeps staff informed of new scientific developments, laws, policies, and objectives that affect Division programs and activities.

    Travel Required

    Not required

    Supervisory status

    Yes

    Promotion Potential

    15

    Who May Apply

    This job is open to…

    Agency Employees Only - Appearing on USAJOBS

    Questions? This job is open to 1 group.

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    Requirements

    Conditions Of Employment

    • U.S. Citizenship is required for Federal employment.
    • Time-in-Grade must be met by announcement close to be considered eligible.
    • Transcripts required.
    • SF-50 required.

    Additional Conditions of Employment:

    • Security and Background Requirements: Appointment will be subject to the applicant's successful completion of a background security investigation. Failure to successfully meet these requirements may be grounds for appropriate personnel action. If hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.
    • E-Verify: If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.
    • Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
    • Pre-employment physical required: No
    • Drug testing required: No
    • License required: No
    • Mobility agreement required: No
    • Immunization required: No
    • Bargaining Unit Position: No
    Financial disclosure statement, OGE- 450, required:
    Please be advised that this position will 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.


    All qualification requirements must be met by 11:59 pm (Eastern Time) on the closing date of this announcement, 12/18/2017.

    Qualifications

    In order to qualify for Supervisory Interdisciplinary Scientist,GS- 401/403/405/1320-15, you must meet Time-in-Grade requirements by 12/18/2017.

    BASIC REQUIREMENT

    Biologist, GS- 401:

    Degree: biological science, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position; OR combination of education and experience with courses equivalent to a major as shown above, plus appropriate experience or additional education.

    Microbiologist, GS- 403:
    Degree: microbiology, biology, chemist, or basic medical science that include 20 semester hours in microbiology or other subjects related to the study of microorganisms and 20 semester hours physical and mathematical science combing course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent; OR Combination of education and experience--Courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown above, plus appropriate experience or additional education.

    Pharmacologist, GS- 405:
    Degree: biology, medical, veterinary, or physical science, or in pharmacy that included at least 30 semester hours in chemistry and physiology; and 12 semester hours in pharmacology.

    Chemist, GS- 1320:
    Degree: physical science, life science , or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics; OR Combination of education and experience--Course work equivalent to a major as shown in A above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education.

    In addition to the above, applicants must meet the below specialized experience:
    At least one year of specialized experience equivalent to the GS- 14 grade level in the Federal service, to include 1) Leading a staff that performs technical, administrative, protective, investigative, or professional work; 2) Providing technical oversight and guidance pertaining to the design, control, manufacturing processes, sterility assurance and/or microbiology controls of products to validate the overall quality; 3) Overseeing the review of Investigative New Drug Applications (IND), New Drug Applications (NOA), Biologic License Applications (BLA), Abbreviated New Drug Applications (ANDA), and/or their supplemental submissions; and 4) Developing and implementing policies to establish standards for the Office related review activities, including novel and complex product design and/ or manufacturing technologies.
    Prior supervisory training and experience is preferred.

    In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an SF-50 or SF-52 documenting an official detail or other official assignment. The documentation must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation of such experience as indicated above.

    Education

    If you are claiming education as any part of your qualifications for this position, you must submit an official transcripts, 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 to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program.

    Additional information

    • If you are serving, or have served in the last 5 years (from 12/18/2017) 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. Political Appointees FAQ - OPM
    • Selective Service Registration: Males born after December 31, 1959 must be registered or exempt from Selective Service. You can learn more by visiting the Selective Service Registration site.

    How You Will Be Evaluated

    Once the job opportunity announcement closes (at 11:59 pm ET on 12/18/2017), a review of your resume 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 or not 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 or your score may be adjusted to more accurately reflect your skills and abilities.
    Please follow all instructions carefully. Errors or omissions may affect your eligibility.

    Basis of Rating: Merit Promotion Procedures for the Food and Drug Administration (FDA) will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be ranked into one of two categories: Best Qualified or Qualified.
    Your qualification will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.

    1. Supervisory Responsibilities
    2. Strategic Planning
    3. Quality Assurance
    4. Communication

    Background checks and security clearance

    Security clearance

    Q - Nonsensitive

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    Required Documents

    The following documents are ACCEPTED for this vacancy:

    • Other
    • Resume
    • SF-50
    • Transcript

    "Accepted" means that you will have the opportunity to submit these documents if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants.

    The following documents are REQUIRED for this vacancy:
    • Resume
    SF-50

    "Required" indicates that the above documents are required to determine your qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or not qualified. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.


    Current FDA Employees and PHS Commissioned Officers: You must submit your most recent SF-50 (Standard Form 50 - Notice of Personnel Action). To properly verify status eligibility, your SF-50 must show the following. If you do not submit an appropriate SF-50, we cannot verify your status eligibility!
    1. Full position title;
    2. appointment type;
    3. occupational series;
    4. pay plan, grade, and step;
    5. tenure code; and
    6. service computation date (SCD).
    If your current position SF-50 does not indicate you have competitive service status or does not reflect the pay plan and grade of the highest position you have held in the competitive service, in addition to your current SF-50, you must provide your previous SF-50s that provide the proof of competitive status and highest grade held on a permanent basis.

    If you are relying on your education to meet qualification requirements:

    You MUST submit a copy of your transcript if you want to substitute your education for experience. If you claim qualifications based on education, and do not submit a transcript, your education will not be used in making a qualification determination and you may be found "not qualified".

    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.

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    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.

    https://www.usajobs.gov/Help/working-in-government/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.

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    How to Apply

    To apply for this position, you must complete the assessment questionnaire and submit all documentation specified in the Required Documents section below. To receive consideration for this position you must submit your complete application by 11:59 pm Eastern Time on the closing date of this announcement, which is 12/18/2017.

    Instructions for applying to this job:

    1. You must be signed in to USAJOBS. If you do not have a USAJOBS account, you must first create one before you can apply
    2. If you are signed in, you can tap/click "Apply Online" to begin the process.
    3. USAJOBS will ask you to select a resume to submit. We recommend that you submit a USAJOBS Resume Builder formatted resume so that you know you're submitting all the information we will need. You may also submit a resume in the format of your choice. For tips on what to include in your resume, see the USAJOBS Resume Help site.
    4. USAJOBS will then allow you to include documentation from your USAJOBS Saved Documents area. You may also attach additional supporting documents during this stage, or you may wait until you reach Application Manager.
    5. You will then be required to respond to certify your application materials and you'll be given the chance to elect to provide demographic information (if you have completed this part of your USAJOBS profile).
    6. Finally, you will be transferred to FDA's Application Manager (USA Staffing) system to complete the occupational questionnaire and finalize your application for submission. Follow the on-screen instructions provided and respond to ALL questions presented to you. You will be allowed to finalize and submit additional documents one last time. You will review your application and make final submission. You will then be returned back to USAJOBS.
    Instructions for reviewing or editing your application:
    1. If you need to make a change to your application, or if you just want to know your application status, you will need to be logged in to your USAJOBS account. Tap/click on your name in the top-right corner, then select "Applications".
    2. You will see a list of the most recent applications you have submitted. Tap/click on the one you wish to review or edit. The item will expand and provide your current status, along with additional information about that application. If you wish to change something then tap/click the "Update Application" button.
    3. You will be taken through the same steps you did when you initially applied. You can make changes to add or remove supporting documents before being transferred over to FDA's Application Manager system where you can continue making changes to your responses to the occupational questionnaire. Step through the process as you did the first time, taking care to make the changes you need, and submitting in the final step.
    If you would like to preview the assessment questionnaire you may do so by clicking this link: https://apply.usastaffing.gov/ViewQuestionnaire/10086251

    You are encouraged to apply online. Applying online will allow you to review and track the status of your application.
    This agency provides reasonable accommodation to applicants with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please contact the Bethesda Customer Help Desk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email quickquestions@fda.gov. (In your e-mail request, please replace the blank line with the Vacancy Identification Number, VIN, for this job, which is:
    10086251. Decisions for granting a reasonable accommodation will be made on a case-by-case basis.

    Agency contact information

    FDA Applicant Help Desk

    Address

    FDA Center for Drug Evaluation and Research
    10903 New Hampshire Ave
    Silver Spring, MD
    US
    Learn more about this agency

    Visit our careers page

    Learn more about what it's like to work at Food and Drug Administration, what the agency does, and about the types of careers this agency offers.

    https://www.fda.gov/aboutfda/workingatfda/default.htm/

    Next steps

    Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful. The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview. We expect to make a selection within 45 days of the closing date of this announcement.
    You will receive application status updates via email and via USAJOBS as the process unfolds.

Fair & Transparent

The Federal hiring process is setup to be fair and transparent. Please read the following guidance.

Equal Employment Opportunity Policy

The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy And gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.

Reasonable Accommodation Policy

Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application and hiring process should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a Case-by-Case basis.

A reasonable accommodation is any change in the workplace or the way things are customarily done that provides an equal employment opportunity to an individual with a disability. Under the Rehabilitation Act of 1973 the Equal Employment Opportunity Commission (EEOC) must provide reasonable accommodations:

  • An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.
  • An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.
  • An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events.

Legal and regulatory guidance

This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/485095400. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.