Overview:

　　The Biomedical Advanced Research and Development Authority (BARDA) within the office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) improves national preparedness for chemical, biological, radiological, and nuclear (CBRN) accidents and attacks, pandemic influenza, and emerging infectious diseases by supporting the development and acquisition of medical countermeasures (MCM) against these threats.

　　Industry Specialist

　　Required Tasks and Responsibilities:

　　Provide scientific and technical insight in at least one of the following areas within both the healthcare and pharmaceutical industries: pharmaceuticals, biotechnology, biologics, vaccines, therapeutics, diagnostics, and emerging manufacturing technologies.

　　Advise on regulatory and quality affairs pathways for successful review of planned and known ASPR procurements that require regulatory clearance through other agencies, such as the Food and Drug Administration (FDA).

　　Advise on innovative and novel approaches to support successful development, manufacturing, licensure, and distribution of MCMs and other health resources necessary to prepare for, respond to, and recover from public health threats.

　　Advise on critical programmatic and project level regulatory challenges.

　　Facilitate engagement between HHS/ASPR and national organizations focused on the manufacturing of materials and supplies necessary to produce health resources deemed essential for national defense.

　　Provide scientific and technical support on execution of industry project analyses to provide recommendations for development, optimization, and/or maintenance efforts for mission-

　　specific or mission critical challenges/issues.

　　Produce clear, concise written reports and oral briefs to effectively communicate objectives and approaches to non-technical audiences.

　　Conduct other tasks as assigned in keeping with the scope of this TO.

　　Be proficient with all MS Office products, Adobe Acrobat.

　　Experience and Qualification Requirements:

　　An advanced degree or doctoral degree in biology, biotechnology, chemistry, or pharmacy with commensurate experience.Relevant experience supporting the successful regulatory clearance of a drug, medical device and/or product, biologic, or therapeutic through the FDA is preferred. Possess extensive knowledge of FDA/ICH guidelines.About Drodex:

　　Drodex LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

　　This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.