This position is located in the Center for Biologics Evaluation and Research (CBER), Office of Tissue and Advanced Therapies (OTAT) located in Silver Spring, MD.Learn more about this agency
This vacancy is also being announced concurrently with vacancy announcement FDA-CBER-18-DE-10191117 under delegated examining procedures. Please review that announcement to see if you are eligible for consideration under delegated examining procedures. Applicants must apply separately for each announcement in order to be considered under both.
Additional selections may be made within the same geographical area FDA-wide.
The incumbent of this position will:
- Evaluate and interpret preclinical data, which contributes to complex, long range, and emerging issues of both a scientific and regulatory nature.
- Review and evaluate the biomedical engineering, toxicological and pharmacological data contained in Investigational New Drug (IND) submissions and Investigational Device Exemptions (IDE), as well as amendments and supplements, respectively, to support the safety of cell therapy, gene therapy, and tissue-engineered products that are regulated by CBER/OTAT.
- Exchange ideas with other peers in the scientific and regulatory communities engaged in related areas.
- Evaluate the effects of the investigational cell therapy, gene therapy, or tissue-engineered product on organ systems, tissues, cells, and animals.
25% or less - You may be expected to travel for this position.
Job family (Series)
Conditions of Employment
- Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement.
- 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.
- Selective Service Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service OR have an approved exemption.
- FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the problem.
- Security and Background Requirements: Appointment will require passing a background investigation. Not meeting this requirement may be grounds for personnel action. If hired, you may be subject to a background check at a later time.
- 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.
- Direct Deposit: You will be required to have your federal salary payments electronically deposited into an account with a financial institution of your choice.
- 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.
QualificationsIn order to qualify for Biomedical Engineer, 0858, at GS - 13, you must meet Time-in-Grade requirements by 05/25/2018.
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.
BASIC EDUCATION REQUIREMENT:
All applicants must meet the following education requirement:
0858- Degree: Engineering. To be acceptable, the program must: (1) lead to a bachelor's degree in a school of engineering with at least one program accredited by ABET; or (2) include differential and integral calculus and courses (more advanced than first-year physics and chemistry) in five of the following seven areas of engineering science or physics: (a) statics, dynamics; (b) strength of materials (stress-strain relationships); (c) fluid mechanics, hydraulics; (d) thermodynamics; (e) electrical fields and circuits; (f) nature and properties of materials (relating particle and aggregate structure to properties); and (g) any other comparable area of fundamental engineering science or physics, such as optics, heat transfer, soil mechanics, or electronics.
Combination of education and experience -- college-level education, training, and/or technical experience that furnished (1) a thorough knowledge of the physical and mathematical sciences underlying engineering, and (2) a good understanding, both theoretical and practical, of the engineering sciences and techniques and their applications to one of the branches of engineering.
SPECIALIZED EXPERIENCE REQUIREMENT:
IN ADDITION TO MEETING THE BASIC EDUCATION REQUIREMENT, ALL APPLICANTS MUST ALSO:
In order to qualify for the position of IDS, GS-0401-0405-0415-13, you must have one year of specialized experience, equivalent to the GS-12 in the Federal service which include Experience in
1) designing pre-clinical pharmacology or toxicology studies to analyze medical products related to one or more of the following: cell therapy products, gene therapy products, tissue-engineered products, plasma derivatives, and hemostatic products; 2) analyzing and reviewing data to assess the safety and activity of therapeutic products; 3) providing advice and scientific guidance on the preclinical assessment of cell therapy, gene therapy, tissue-engineered, plasma derivatives, and/or hemostasis products.
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 to apply for this vacancy. For most applicants, an SF-50 will be required. However, if you are applying based as a Veteran, person with a disability, or a displaced former employee, you will be required to provide other supporting documents as applicable. See the Required Documents section for more details.
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
- 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 05/25/2018) 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.?
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 05/25/2018), 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 pertinent laws, regulations and Federal policies as they pertain to toxicology/pharmacology issues of a scientific and regulatory nature.
- Knowledge of the principles, practices and theories in evaluating preclinical study designs and resultant data.
- Ability to communicate orally.
- Ability to communicate in writing.
Background checks and security clearance
The following documents are REQUIRED for this vacancy:
"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.
The Federal Government has very specific requirements for the information that you must include in your resume. A resume for a Federal job will be much longer and more complete than the type of resume you may be familiar with from the private sector. If you have not written a Federal resume before, you may want to watch this Resume Writing Tutorial video on the USAJOBS YouTube channel, or read through a helpful Resume Writing FAQ article on the USAJOBS Help Site.
The following documents are ACCEPTED for this vacancy:
- Other Veterans Document
"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.
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).
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 disability from 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.
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
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, 05/25/2018 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) 10191118 so that we may assist you faster.
Agency contact information
FDA Applicant Help Desk
AddressCenter for Biologics Evaluation and Research
10903 New Hampshire Ave
Silver Spring, MD 20993
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
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 process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants 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.
Legal and regulatory guidance
This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/499292400. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.