FDA Department of Health and Human Services Instructions
- June 12, 2024
- FDA
Table of Contents
FDA Department of Health and Human Services Instructions
Title 21 Vacancy Announcement
Department of Health and Human Services (HHS)
Food and Drug Administration (FDA)
Center for Biologics Evaluation and Research (CBER)
Office of Vaccines Research and Review (OVRR)
Division of Vaccines and Related Product Applications (DVRPA)
CMC Review Branch 3 (CMCRB3)
Application Period: August 28, 2023 – September 11, 2023
Area of Consideration: The Public United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.
Position: Biologist
Location(s): White Oak Campus, Silver Spring, Maryland
Work Schedule: Full Time
Cures Band: Band C
Travel Requirements : 25% or less
Bargaining Unit: 3591
Series: 401
Salary Range: $112,015 – $155,978
Telework Eligible: Yes
Full Performance Band Level: Band C
Note : 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.
This position is being filled under a stream-lined hiring authority, Title 21,
Section 3072 of the 21st Century Cures Act. The
candidate selected for this position will serve under a career or career-
conditional appointment and be paid under the
provisions of this authority.
Additional information on 21st Century Cures Act can be found here:
21st Century Cures Act Information
Introduction
The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.
The Center for Biologics Evaluation and Research (CBER) is a Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. CBER’s mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. CBER protects and advances the public health by ensuring that biological products are safe, effective, and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.
The Office of Vaccines Research and Review (OVRR) protects and enhances public health by assuring those available vaccines, allergenic extracts, and related product are safe and effective.
The Division of Vaccines and Related Product Applications (DVRPA) directs and performs the review process for investigational new drug applications (INDs), biological license applications (BLAs), and amendments with regard to biological drug products regulated by the Office. DVRPA coordinates the processing of INDs and BLAs through DVRPA and the other Divisions within the Office and within other Offices in the Center and coordinates licensing activities among the Divisions. DVRPA develops policies and procedures applicable to the review of preclinical information and clinical trial design and data submitted in support of BLAs and INDs.
Duties/Responsibilities
The Biologist coordinates and performs the review process of Investigational
New Drug applications (INDs) for biologics and Biologics License Applications
(BLAs), including supplements to BLAs and related regulatory submissions. The
Biologist plays a central role in assisting Agency decision-making and
recommending advice with regards to these applications. The Biologist serves
as the project manager for information requests from upper management, other
organizational divisions, and the regulated industry.
Specifically, the Biologist will:
- Serve as point of contact for OVRR in communicating the decisions and advice to the Sponsors of these Applications and manufacturers of these vaccines.
- Coordinate, attend, and manage meetings (e.g., Pre-IND, IND, pre-BLA, BLA, etc.) with representatives of pharmaceutical companies, IND Sponsors and licensed manufacturers of vaccines.
- Review data submitted by manufacturers and Sponsors of new biologics to be used for clinical investigations and compose subsequent official responses.
- Evaluate the adequacy of the IND submission to ensure compliance with the New Drug regulations prior to interstate shipment of products.
- Review sections of these submissions that pertain to their area of expertise.
- Evaluate manufacturing and animal immunogenicity data with particular emphasis on identification of hazards, including presence of potential and known harmful agents, relevance to clinical development and conformity to quality control criteria.
- Evaluate all aspects of the clinical study protocol including safety and effectiveness of a drug when used in the particular study population.
- Evaluate clinical study protocols for design elements and regulatory compliance
Conditions of Employment
- U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
- Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
- Applicants must meet all qualification requirements by the closing date of this announcement.
- 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.
- 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.
- Males born after December 31, 1959, must be registered with the Selective Service.
- Financial Disclosure may be required.
- Ethics Clearance may be required.
- Background Investigation/Security Clearance is required. 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.
Qualifications
To be placed into a Cures position, candidates must meet the following criteria:
- Scientific, Technical, and Professional Fields
- Qualified and Outstanding Candidates
a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the basic requirements defined in the OPM Qualification Standards as a baseline for comparing experience levels and other candidate attributes for relevant positions.
b. Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.
In order to qualify for this Title 21 Cures position, the candidate(s) must meet the following required qualifications. Please note: Additional education and experience listed that is not indicated as required is preferable and desired. Candidates who do not meet the “desired” criteria will not be excluded from consideration for this position.
Education Requirement:
Candidates must possess the required individual occupational requirements to
qualify for the appropriate series applicable to the position. Please use the
following link to determine the series for which you qualify:
https://www.opm.gov/policy-dataoversight/classification-qualifications
/general-schedule-qualification-standards/#url=List-by-Occupational-
Series
Education Transcripts
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 FDA employee, you are not exempt from transcript requirements.
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 more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.
Security Clearance Requirements
Background Investigation/Security Clearance Requirements: Background
Investigation/Security Clearance is required. 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.
Ethics Clearance Requirements
This position may require financial disclosure reporting and 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. For more information please visit the FDA Ethics web
page:
https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.
Equal Employment Opportunity
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
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. Learn more about
disability employment and reasonable accommodations or
how to contact an agency.
E-Verify
The Food and Drug Administration participates in the USCIS Electronic
Employment Eligibility Verification Program (E-Verify). EVerify helps
employers determine employment eligibility of new hires and the validity of
their Social Security numbers.
How to Apply
Please submit electronic resume or curriculum vitae (please be sure to clearly
define the number of years using month and year training completed, in
addition to describing duties performed during that time period), SF50 (if
applicable), latest PMAP (if applicable), copy of unofficial transcripts, and
letter of interest with “CURES CBER/OVRR/DVRPA/CMCRB3 Biologist in the
subject line to: CBERHumanCapital@fda.hhs.gov.
Applications will be accepted through September 11, 2023.
Announcement Contact
For questions regarding this Cures position, please contact:
CBERHumanCapital@fda.hhs.gov
FDA is an equal opportunity employer.
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>