Consumer Safety Officer

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.

Duties/Responsibilities

The incumbent serves as the Consumer Safety Officer in the Division of Manufacturing and Products Quality (DMPQ) under the Office of Biologics Quality (OCBQ) within CBER. DMPQ is responsible for the review of facilities, equipment, manufacturing, controls and Good Manufacturing Product (GMP) related issues in biological applications, and supplements and inspections associated with the manufacturing of biological products. These biological products include vaccines and bacterials products, allergenics, plasma fractionated products, blood donor screening tests, and cellular and gene therapy products.

Specifically, the Consumer Safety Officer will:

• Handle submissions that are distinctly more difficult because of the technology, science, and the complex regulatory issues associated with these products.
• Serve as an expert in biological product manufacturing and provide written and verbal conclusions to FDA components and industry regarding compliance with CGMP regulations and FDA establishment standards.
• Identify and assess emerging or complex issues, advises supervisors of potential problem areas, and formulates appropriate responses.
• Possess experience with manufacturing facilities, manufacturing process, technological changes, quality systems and industrial changes in association with the review of submissions, the pre-license/approval inspections for these applications/supplements, and during FDA/industry meetings regarding the manufacturing and facilities for regulated biologic products.
• Apply specialized knowledge of the manufacture of biologic products in the analysis of complex technical and scientific issues identified in critical submissions, determining the best course of action based on a specialized knowledge of manufacturing and product quality.
• Serve as a subject matter expert across multiple subject areas demonstrating mastery level scientific knowledge and provides consultation to management and staff to address technical inquiries.
• Provide verbal and written conclusions regarding these reviews and inspections to FDA components and industry in the form of review memos and inspection reports.
• Serve on working groups to develop critical guidance for industry pertaining to the manufacture of biologic products.
• Participate in educating industry and FDA on such guidance through workshops for industry or presentations at industry/FDA conferences.
• Advise the branch, division and agency staff in the review and evaluation of manufacturing processes and facilities to ensure compliance with the laws and applicable regulations and ensure consistency.
• Maintain expert knowledge of the Federal Food Drug and Cosmetic Act and noted amendments; the Public Health Service Act; and all other Acts enforced by the Agency, as well as the regulations and policies promulgated under these Acts used in the regulation of biologic products and devices.
• 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), a copy of your unofficial transcripts, SF50 (if applicable), latest PMAP (if applicable), and letter of interest with “CURES CBER/OCBQ/DMPQ/Consumer Safety Officer” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through March 15, 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.