Industry Specialist

Overview

The Administration for Strategic Preparedness and Response (ASPR) is a public health preparedness and emergency response organization in the Office of the Secretary at the United States Department of Health and Human Services. ASPR was created under the Pandemic and All-Hazards Preparedness Act in the wake of Hurricane Katrina to lead the nation in preventing, preparing for, and responding to the adverse health effects of public health emergencies and disasters.

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

Required Education:

Required Experience:

• 8+ years of relevant industry experience as mid or senior technical operations (i.e., manufacturing, quality, regulatory, etc.) positions in the pharmaceutical or healthcare industries
• Possess extensive knowledge of FDA/ICH guidelines and requirements

Desired Experience:

• Relevant experience supporting the successful regulatory clearance of a drug, medical device and/or product, biologic, or therapeutic through the FDA is preferred
• Understanding of manufacturing best practices or the pharmaceutical supply chain
• ISO 9001 certification or understanding of the process
• Experience with large-scale procurement
• Cold Chain experience

Required Clearance:

• Ability to obtain Public Trust Clearance

About Aveshka:

Aveshka is a professional services firm focused on addressing our nation's most complex threats and challenges. As a small business we're committed to supporting our clients' missions with services delivered by our diverse and experienced staff. With expertise in cybersecurity, emergency preparedness, and public health, our experience base spans federal, state, and local governments, as well as private sector entities.

Aveshka encourages collaborative communication and ongoing learning. Some of our benefits include:

• Extensive training programs
• Gym membership reimbursement
• Education reimbursement
• Technology benefits
• Commuter benefits
• Generous paid time off and much more!

Aveshka is an Equal Opportunity Employer (EOE)