Branch Chief

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 InformationIntroduction 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 Branch Chief for Manufacturing Review Branch 1 (MRB1) within the Division of Manufacturing and Product Quality (DMPQ) under the Office of Compliance and Biologics Quality (OCBQ) reports to the DMPQ Division Director. The MRB1 Branch Chief is responsible for the planning, organization, and supervision of the overall regulatory, administrative and control activities for the Branch. The Branch Chief is responsible for hiring decisions, work assignments, and the day-to-day operation of the Branch. The Branch Chief provides direction, clarification and interpretation of policy and technical issues for the Branch which consists of a professional staff. The Branch is responsible for the review of submissions, conducting inspections, and takes appropriate actions on investigational new drug (INDs) applications, marketing applications, supplements and amendments submitted to CBER. The review work is primarily the Chemistry, Manufacturing and Controls and facility-related sections for CBER-regulated products. Specifically, the Branch Chief will: - Provide guidance and support for all program activities, perform regulatory reviews of all submissions, coordinate the scientific reviews of the applications done by other Office divisions, conduct scientific reviews for assigned submissions, and develop policy with regard to the products under the jurisdiction of the Office, assuring consistency as appropriate with policies and actions of other Offices within the Center. - Review, evaluate, and take appropriate action on INDs, marketing applications, supplements, and amendments submitted to the CBER, as part of the managed review process; and performs CMC and CGMP reviews. - Support enforcement activities by evaluating inspection reports and corrective actions when inspections are performed by CBER or field components. - Evaluate and coordinate regulatory policy and actions proposed by the scientific division for approval/ disapproval of investigational and marketing applications. - Meet with manufacturers to review facility design/CGMP/new products and technologies. - Lead and provide oversight and direction for pre-license and preapproval inspections supporting Biologics License Application submissions and supplements and other marketing applications, as part of the CBER managed review process. - Serve as the focal point of expertise and guidance to manufacturers, consumers, academia, Agency committees, other government agencies, DMPQ and Office staff on the implementation of new laws, regulations, and policies impacting on products; evaluates proposed regulations, Agency guidelines, and Center/Office policies for consistency of interpretation and meaning, accuracy, and practical application. - Work with the Division Director and Deputy Director to develop the Agency position in response to request for advisory opinions from the regulated industry, non-government health related organizations, Department officials, etc., to cover the full range of subject matter areas within the Center. - Provide expert technical and regulatory guidance and training to CBER and other Food and Drug Administration (FDA) components, government agencies, and representatives of domestic and foreign biological establishments regarding biological product manufacturing and quality, in coordination with the Office of Communication, Outreach and Development.

Supervisory Responsibilities:Organizational Management: Manages a Branch. Program Management: Runs a program of singular discipline focus in the Center. Oversees or coordinates multiple functional activities. Resource Management: Monitors and reports on resources needed to run a Branch in the Center. Personnel Performance Management: Counsels and rates immediate subordinates. Human Capital Management: Identifies employee competency gaps. 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 your unofficial transcripts (if applicable), SF50 (if applicable), latest PMAP (if applicable), and letter of interest with “CURES CBER/OCBQ/DMPQ/MRB1 Branch Chief”__ in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through April 21, 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.