Chemist

Employer
USAJobs
Location
Rockville, Maryland
Posted
Mar 05, 2021
Closes
Mar 07, 2021
Function
Administrative
Hours
Full Time
Duties

Summary

This Direct-Hire position is in the Food and Drug Administration and is located in the Center for Veterinary Medicine, Office of New Animal Drug Evaluation/Division of Generic Animal Drugs.

Learn more about this agency

Responsibilities

  • You will conduct scientific reviews of Generic New Animal Drug Applications (ANADAs) and Generic Investigational New Animal Drug files (JINADs) for technical information supporting bioequivalence of a generic animal drug product.
  • You will use regulatory knowledge and discretion to ensure review activities are aligned with laws, regulations (e.g., Good Laboratory Practices), and policies which may require interpretation or adaptation.
  • You will collaborate and assist other scientists from industry, academia and/or government agencies in providing knowledge related to analytical medicinal/pharmaceutical chemistry, dissolution chemistry, bioequivalence, patents, and labeling.


Travel Required

Not required

Supervisory status
No

Promotion Potential
13

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.
  • 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.
  • Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities. Your application may be shown to multiple hiring offices.
  • 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.
  • Telework is at the discretion of the supervisor.
  • This position may be subject to completion of a 1-year probationary period (unless you have already satisfied this obligation).
  • This Term Appointment may be extended up to the four year limit.


Qualifications

The position of Chemist falls under the 1320 occupational series. To qualify for this position at grade GS-11/12, you must meet the following:

Basic Requirements

Possess a degree in physical sciences, life sciences, 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 possess a combination of education and experience -- Courses equivalent to a major as shown 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 (must submit transcript).

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

Minimum Qualifications Requirements for GS-11
Possess one year of specialized experience equivalent to the GS-09 level in the Federal service. Experience includes assisting in conducting scientific analysis of data regarding drug substances such as new or generic animal drugs or drug products; and assisting in preparing and presenting research findings on chemistry and/or biology in the bioequivalence of substances(e.g. new generic animal drugs). OR possess 3 years of progressively higher level graduate education leading to a Ph.D. or equivalent doctoral degree OR possess a combination of education and experience. If qualifying based on experience, this experience must be reflected in your resume. Volunteer experience can be used as qualifying experience.

Minimum Qualifications Requirements for GS-12
Possess one year of specialized experience equivalent to the GS-11 level in the Federal service. Experience includes conducting scientific analysis of data regarding drug substances such as new or generic animal drugs or drug products; evaluating the chemical/biological ingredients in substances to determine the identity, strength, quality, and/or purity; and preparing and presenting research findings on the chemistry and/or biology in the bioequivalence of substances (e.g new generic animal drugs).

All qualification requirements must be met by 11:59 pm (Eastern Time) on 03/05/2021. 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

If you are claiming education as any part of your qualifications for this position, 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 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. For further information, click on foreign education .

Submitting Your Transcripts: Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. 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 only receive consideration and credit for the information we can access.

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

Additional information

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 Position: Yes, 3591
  • Telework eligible position: Telework is at the discretion of the supervisor.
Additional Information:
  • 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 03/05/2021) 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 Political Appointee FAQ - OPM for more.


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 03/05/2021), 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.

Background checks and security clearance

Security clearance
Other

Drug test required
No

Position sensitivity and risk
Moderate Risk (MR)

Trust determination process
Suitability/Fitness

Required Documents

  • Resume
  • Transcript

A document that is required must be submitted by all applicants because the document is needed to verify your qualifications, education, or other eligibility information. Failure to provide one of the documents in the list below may result in your application being considered incomplete.

  • Cover Letter
  • DD-214/ Statement of Service
  • Disability Letter (Schedule A)
  • Disability Letter (VA)
  • License
  • Other supporting documentation not listed above
  • PCS Orders
  • Performance Appraisal
  • Professional Certification
  • Resume
  • Separation Notice (RIF)
  • SF-15
  • SF-50/ Notification of Personnel Action
  • Transcript

These documents may be required for some applicants . Applicants relying on education to qualify, those seeking consideration under a special hiring authority, or those who need to verify a license or certification, will need to submit appropriate supporting documentation from this list. RESUME REQUIREMENTS:
The federal government has very specific resume requirements. If you have not written a federal resume before, you should watch this Resume Writing Tutorial video on the USAJOBS YouTube channel , or read through a helpful Resume Writing FAQ on the USAJOBS Help Site to learn what details you should, and should not, include in your resume.
At a minimum your resume should list the position title, employer, 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.

Displaced employees:
If you are a former Federal employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under I/CTAP, you must still be found well-qualified for this position. 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 .

Learn more about supporting documents and documentation requirements on USAJOBS:
  • How to Understand the Required Documents Section
  • What Types of Documents May I Need?
  • How to Manage Your Documents on USAJOBS


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.

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