These positions are being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidates selected for these positions 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 regulating and assuring that available vaccines, allergenic extracts, and related products are safe and effective.
The Division of Review Management and Regulatory Review (DRMRR) directs and performs the review process for Investigational New Drug (IND) Applications, Biologics License Applications (BLAs), and amendments regarding biological drug products regulated by the Office. DRMRR coordinates the processing of INDs and BLAs through the other Divisions within the Office and coordinates licensing activities among the Divisions. DRMRR develops policies and procedures applicable to the review of preclinical information and clinical trial design and data submitted in support of BLAs and INDs.
The Regulatory Review Branches (RRBs) are responsible for handling issues and regulatory submissions related to preventive and therapeutic bacterial, viral, and parasitic vaccines for infectious disease indications, allergenic products, live biotherapeutic products and microbiome-related products.
Duties/Responsibilities
The incumbent serves as a Biologist for one of the Regulatory Review Branches (RRBs) within the Division of Review Management and Regulatory Review (DRMRR) under the Office of Vaccines Research and Review (OVRR). This position reports to the Regulatory Review Branch Chief. 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 incumbent plays a central role in assisting Agency decision-making and recommending advice with regards to these applications. The incumbent 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.
- Perform other duties as assigned.
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), copy of unofficial transcripts, SF50 (if applicable), copy of your active medical license/s (if applicable), copy of your board certification/s (if applicable), latest signed PMAP (if applicable), and letter of interest with “Title 21 CBER/OVRR/DRMRR Biologist, Band C” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through September 16, 2024.
Announcement Contact
For questions regarding this Cures position, please contact: CBERHumanCapital@fda.hhs.gov
The Department of Health and Human Services is an equal opportunity employer with a smoke-free environment.
FDA is an equal opportunity employer.
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