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Interdisciplinary Scientist
SILVER SPRING MD 20915
Category: Pharmacist
  • Your pay will be discussed at your interview

Job code: lhw-e0-89763525

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Food and Drug Administration

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Summary

  Job posted:   Thu May 17, 2018
  Distance to work:   ? miles
       
  1 Views, 0 Applications  
 
Interdisciplinary Scientist
* Duties
Help
## Duties
### Summary
**This position is located in the Center for Biologics Evaluation and Research (CBER), Office of Tissue and Advanced Therapies (OTAT), Division of Cellular and Gene Therapies (DCGT) located in Silver Spring, MD.**
*This vacancy is also being announced concurrently with vacancy announcement **FDA-CBER-18-MP-10208293** under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures. Applicants must apply separately for each announcement in order to be considered under both options.*
**Additional selections may be made within the same geographical area FDA-wide.**
Learn more about this agency
### Responsibilities
The incumbent of this position will:
* Review and evaluate Investigational New Drug Applications (IND), Investigational device Exemptions (IDE), Premarket applications (PMA), 510(k), Biologics License Applications (BLA), amendments and supplemental applications.
* Requests additional information from sponsors and applicants and proposes changes in chemistry, manufacturing or controls when he/she determines that they need to establish and maintain the identity, purity, potency, consistency, or safety of the products.
* Have the skill to apply this combination of knowledge to the review of INDs and BLAs and to interact with members of the regulated industry.
* Have the academic training, practical experience, continuing education, and professional development to interpret and critically evaluate the complex information and data generated by the sponsors including the pharmaceutical industry.
* Have the academic training, practical experience, continuing education, and professional development to interpret and critically evaluate the complex information and data generated by the sponsors including the pharmaceutical industry.
* Attain a mastery of the biology/microbiology and technology in specialty areas of drugs for human use. Mastery includes the principles, theories, and practices of biology, as well as microbiology, molecular biology, virology, genetic engineering, or technology associated with chemistry, manufacturing processes and controls involved in the research, development, and production of drugs and biologics for human use.
* Discuss with the multidisciplinary review team and supervisors scientific and chemistry, manufacturing and controls regulatory matters in the submission under review.
* Provide regulatory guidance on the chemistry, manufacturing and controls issues and relevant procedures regarding cellular or gene therapy products during meetings with sponsors and stakeholders.
* Write regulatory review memos evaluating the sufficiency of regulatory submissions such as IND, BLA, MF, and Pre-IND.
* Draft chemistry, manufacturing and controls comments for regulatory actions.
* Draft regulatory policy and guidance documents on cell or gene therapy manufacturing and controls and related areas.
### Travel Required
Not required
##### Supervisory status
No
##### Promotion Potential
13
* #### Job family (Series)
0401 General Natural Resources Management And Biological Sciences
0403 Microbiology
#### Similar jobs
* Biological Scientists
* Requirements
Help
## Requirements
### Conditions of Employment
* Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement.
* 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.
### Qualifications
**In order to qualify for Interdisciplinary Scientist, 0401/0403, at GS** - **13, you must meet the following:**
BASIC EDUCATION REQUIREMENT:
All applicants must meet the following education requirement:
Series 0401: Degree: 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.
Series 0403: Degree: 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 basic medical science that included courses as shown in A above, plus appropriate experience or additional education.
SPECIALIZED EXPERIENCE REQUIREMENT:
IN ADDITION TO MEETING THE BASIC EDUCATION REQUIREMENT, ALL APPLICANTS MUST ALSO:
In order to qualify for the position of Interdisciplinary Scientist, GS-0401/0403-13, you must have one year of specialized experience, equivalent to the GS-12 in the Federal service which include experience performing human cell or gene therapies research that included human cell or gene therapies publications in peer reviewed journals and presentations at national scientific conferences.
### Education
### Additional information
***ADDITIONAL CONDITIONS OF EMPLOYMENT:***
* **If you are serving, or have served in the last 5 years (from 05/29/2018) 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 Appointee FAQ - OPM
* **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.
* **Pre-Employment Physical:** NO
* **Drug Testing Requirement:** NO
* **License Requirement:** NO
* **Immunization Requirement:**NO
* **Mobility Agreement Required:** NO
* **Bargaining Unit Position:** YES 3591
* **Veteran's Preference:** If you plan to apply for any time of Veterans Preference, please pay careful attention to the "Required Documents" section for more information about what to provide in your application. USAJOBS Veterans Site.
* **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.
* **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.
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### 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 05/29/2018), 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:** Category rating procedures 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 assigned to one of the following quality categories: Best Qualified, Well Qualified, or Qualified.
The Category Rating Process does not add veteran's preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Preference eligibles who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 percent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-9 level or higher).
**Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You need not respond to the KSA's directly, but your resume should contain sufficient information to demonstrate possession of the Competencies.**
1. Scientific knowledge in human cellular or gene therapy product development and manufacturing
2. Analysis and interpretation of complex scientific data in the areas of human cellular or gene therapy products
3. Oral Communication
4. Written communication
**To preview the application assessment questions, use the link below:
**
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### Background checks and security clearance
##### Security clearance
Q - Nonsensitive
* Required Documents
Help
## Required Documents
**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.*
***RESUME REQUIREMENTS:***
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** on the USAJOBS Help Site.
**The following documents are ACCEPTED for this vacancy:**
* Cover Letter
* DD-214
* Other
* Other Veterans Document
* Resume
* SF-15
* 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.*
***ADDITIONAL DOCUMENTATION REQUIREMENTS FOR APPLICANTS WHO WISH TO APPLY FOR SPECIAL APPOINTING AUTHORITIES:***
* **Veterans:**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.
* Benefits
Help
## 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. 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
Help
## 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, **05/29/2018**. 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: -to/. Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at:
**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: 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) 10208292 so that we may assist you faster.*
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### Agency contact information
### FDA Applicant Help Desk
##### Phone
888-478-4340
##### Email
quickquestions@fda.gov
##### Address
Center for Biologics Evaluation and Research
10903 New Hampshire Ave
Silver Spring, MD
US
Learn more about this agency
### 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 strive to make selections within 45 days of the closing date of this announcement (05/29/2018).
***You will receive application status updates via email and via USAJOBS as the process unfolds.***
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* 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
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### 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.
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#### 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/499531700. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.
*Open & closing dates:* 05/15/2018 to 05/29/2018
*Salary:* $96,970 to $126,062 per year
*Pay scale & grade:* GS 13
*Work schedule:* Full-Time
*Appointment type:* Permanent

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