Food and Drug Administration Supervisory Interdisciplinary Scientist in Queens, New York
The Food and Drug Administration's (FDA), Office of Regulatory Affairs (ORA) is the lead office for all FDA Field activities as well as providing FDA leadership on imports, inspections and enforcement policy. ORA supports FDA Product Centers by inspecting regulated products and manufactures, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States. ORA also develops FDA-wide policy on compliance and enforcement.
This position is a first line supervisor in the Northeast Medical Products Laboratory (NMPL) an ORA Field Laboratory. The incumbent will oversee a unit of scientists who perform chemical analysis of pharmaceutical products using a variety of techniques. The NMPL unit is responsible for determining the chemistry of pharmaceuticals and covers several pharmaceutical and compliance programs as well as special assignments, which include generic drugs, compounded products, APIs (Active Pharmaceutical Ingredients) and drug survey samples. Analytical capabilities include NDAs and ANDAs validation and ascertaining whether or not a particular product is authentic or is a disguised innovator product.
This position is located in the Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Northeast Medical Products Laboratory in Queens, NY.
Additional selections may be made within the FDA in the same geographic location.
Who May Apply: 1) Federal employees with career or career-conditional appointments in the competitive service; 2) Former Federal employees with reinstatement eligibility based on previous career or career-conditional appointments; 3) Displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) or the Interagency Career Transition Assistance Program (ICTAP); 4) Veterans who are preference eligibles or who have been separated under honorable conditions after 3 years or more of continuous active service; 5) Military Spouses; 6) PHS Commissioned Corps Officers;
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 submit documentation to verify your eligibility for this vacancy. For most applicants, an SF-50 will be required.
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- Responsible for the technical and administrative supervision of all unit employees which includes planning, assigning, reviewing, and evaluating the work and performance of those employees.
- Perform the administrative and personnel management functions relative to staff supervised.
- Develop and implement team-building techniques.
- Provide input on subordinate staff to the next level management for consideration in strategic planning and budgets taking into account recommendations from team input.
- Support, maintain and improve on existing Quality Assurance and Quality Control policies and procedures.
- Provide technical evaluation of all analysis performed in the laboratory as part of quality management before results are shared outside of the laboratory.
- Assist with designing analytical and regulatory testing strategy.
25% or less - You may be expected to travel 30% of the time for this position.
- #### Job family (Series)
0401 General Natural Resources Management And Biological Sciences
Conditions of Employment
- Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.
- Certification of Accuracy: All information concerning qualification for employment is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.
- 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.
SPECIALIZED EXPERIENCE: Experience directly related to the position to be filled which has equipped the candidate with the particular knowledge, skills, and abilities needed to successfully perform the duties of the position, and that is typically in or related to the position to be filled.
GS-13: Have at least one year of specialized experience, equivalent to at least the GS-12 grade level in the Federal service comprehending knowledge of the basic legislation, laws, precedents, and regulations which govern the activities of a chemistry-based laboratory and associated organizations, skill in negotiating, and comprehending knowledge of laboratory programs. Preferred experience is hands-on knowledge of chemical/pharmaceutical analysis, directing laboratory operations; developing, implementing, and providing guidance on laboratory operational procedures; implementation of/adherence to a lab quality management system; and coordinating and monitoring a science laboratory workload. Knowledge of chemistry lab equipment and concepts such as
In order to qualify for Supervisory Interdisciplinary Scientist, 0401/0403/1320, at GS -13, you must meet Time-in-Grade requirements as well as the specialized experience.
Time in Grade: GS-13: Applicants must have 52 weeks at the GS-12 or higher.
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.
Foreign Education: 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; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit: http://www.ed.gov/.
This position has an education requirement. You must submit a copy of your transcripts (or a list of your courses including titles, credit hours completed and grades) to document that you have met the education requirement. Unofficial transcripts will be accepted in the application package; however, official transcripts will be required prior to beginning employment.
Applicants must have successfully completed one of the following:
GS-0401, Biologist: Degree in 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 in A above, plus appropriate experience or additional education.
GS-0403, Microbiologist: Degree in microbiology; or biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining 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 medical science that included courses as shown in A above, plus appropriate experience or additional education.
GS-1320, Chemist: Degree: 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. 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.
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: No
- Supervisory Probationary Period: Yes, one year.
- 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.
- If you are serving, or have served in the last 5 years (from 03/22/2018) 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
- Veteran's Preference: If you plan to apply for any kind of Veteran Preference, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. USAJOBS Veterans Site.
- Schedule A: If you plan to apply under Schedule A based on a disability, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. Disability Employment
- Inter-agency and Career Transition Assistance Programs: If you are a displaced Federal employee and plan to apply under CTAP or ICTAP, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. Workforce Restructuring
- Financial disclosure statement, OGE-450, required: This position 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. All requirements must be met by the closing date of this announcement (03/22/2018); only education and experience gained by this date will be considered.
How You Will Be Evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
Once the job opportunity announcement closes (at 11:59 pm ET on 03/22/2018), 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 qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of these Competencies.
- Knowledge of the sciences and chemistry-based principles/theories and laboratory methodology.
- Ability to lead operating staff.
- Ability to analyze organizational and operational issues and problems and develop solutions.
- Ability to communicate in writing.
- Ability to communicate orally. To review the application questionnaire, click the link below. https://apply.usastaffing.gov/ViewQuestionnaire/10157306
Background checks and security clearance
Q - Nonsensitive
- Required Documents
The following documents are ACCEPTED for this vacancy: * Cover Letter * DD-214 * 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 * Transcript "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.
STATUS CANDIDATES - REQUIRED DOCUMENT DETAILS
Current and former Federal employees: You will need to submit a copy of 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!
- Full position title;
- Appointment type;
- Occupational series;
- Pay plan, series, grade, and step;
- Tenure code; and
- 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.
Veterans: You will need to submit appropriate veteran eligibility documentation (DD-214 Member #4 Copy, VA Letter, Standard Form (SF) 15 as applicable). Please note: If you are a veteran who has not yet been discharged, you may provide a statement of intent to discharge from your agency to receive Veterans Preference under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011.
Persons with Disabilities: Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities may apply for appointment through the Schedule A hiring authority. Certified verification of a disabilityfrom a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required.
Displaced Federal employees who qualify for CTAP/ICTAP: 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. Please see the OPM Guide to Career Transition for more information.
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.
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. Learn more about federal benefits.
Review our 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 to Apply
How to Apply
To apply for positions with the Food & Drug Administration, you must have a USAJOBS account and be signed in to that account when you click "Apply Online". Additionally, you must provide a resume, 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, 03/22/2018 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 deadline, and in most cases, only experience and education obtained by this date will be considered.
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/.
The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are unfamiliar with Application Manager, and you encounter any difficulty with the site, we recommend that you first consult 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 888-478-4340, 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) 10157306 so that we may assist you faster.
Agency contact information
FDA Applicant Help Desk
FDA Office of Regulatory Affairs 10903 New Hampshire Ave Silver Spring, MD US
Learn more about this agency
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 strive to make selections within 45 days of the closing date of this announcement. You will application status updates via email and via USAJOBS as the process unfolds.
- Fair & Transparent
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.
- Equal Employment Opportunity (EEO) for federal employees & job applicants
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 to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits.
Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when:
- 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.
You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis.
Learn more about disability employment and reasonable accommodations or how to contact an agency.
Legal and regulatory guidance
- Financial suitability
- Social security number request
- Privacy Act
- Signature and false statements
- Selective Service
- New employee probationary period
This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/493719200. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.
Open & closing dates: 03/13/2018 to 03/22/2018
Salary: $99,927 to $129,906 per year Salary range listed incudes locality pay.
Pay scale & grade: GS 13
Work schedule: Full-Time
Appointment type: Permanent