Research Scientist

2 weeks ago


DC, United States Systems Planning and Analysis, Inc. Full time

Overview

Systems Planning and Analysis, Inc. (SPA) delivers high-impact, technical solutions to complex national security issues. With over 50 years of business expertise and consistent growth, we are known for continuous innovation for our government customers, in both the US and abroad. Our exceptionally talented team is highly collaborative in spirit and practice, producing Results that Matter. Come work with the best We offer opportunity, unique challenges, and clear-sighted commitment to the mission. SPA: Objective. Responsive. Trusted.

The Joint, Office of the Secretary of Defense, Interagency Division provides expert support services to a range of customers spanning across the Department of Defense, Federal Civilian, and international markets. JOID provides a diverse portfolio of analytical and programmatic capabilities to help our customers make informed decisions on their most challenging issues.

The Critical Infrastructure Group (CIG) within JOID provides technical, programmatic and analytical support to customers with missions in national security to include the Department of Homeland Security (DHS), Health and Human Services (HHS), and the Federal Aviation Administration (FAA). The Group brings technical and operational expertise in fields of countering weapons of mass destruction, critical infrastructure protection, emergency response, nuclear non-proliferation, weapons deployment programs, and transportation safety. In addition to management and advisory services, CIG staff collaborate closely with our clients to provide high-quality modeling, simulation, software, and analytical products to meet the most demanding government standards and timelines.

We have an upcoming need for a Research Scientist to assist our customers at Health and Human Services (HHS) onsite in Washington, DC.

Responsibilities

Support the ASPR Innovation efforts, including but not limited to all ASPR solicitation requirements and support the review of White Papers and Full Proposals. Provide subject matter expertise in supporting Medical Counter Measure (MCM) development pathways, the preferred areas of expertise include regulatory, engineering, facilities and infrastructure, large and small molecule CMC, or within the MCM areas of PPEs, diagnostics, or innovative manufacturing technologies. Provide support as a regulatory and quality affairs SME on pathways for the 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 regulatory and quality affairs approaches for the successful development, licensure, and manufacturing and distribution of drugs, medical devices and/or products, and therapeutics as required. Advise ASPR leadership on critical programmatic and project-level regulatory challenges. Provide training and advisement to ASPR leadership on regulations, authoring regulatory documents, and interactions with regulatory authorities. Support other Contractors supporting ASPR & IBMSC efforts as required.

Qualifications

Required Qualifications:

* PhD in pharmacology, biology, microbiology, or relevant related field
* 10+ years of experience
* Subject matter expertise in pharmaceuticals, biostatistics, epidemiology, or clinical investigation
* U.S. citizenship

Desired Qualifications:

* 10+ years industry experience in pharma/biotech/diagnostics or PPE construction, manufacturing, or product development
* Federal civilian experience with HHS or an associated agency
* Previous experience involving grants administration in a Federal civilian environment

Please note that the salary information shown below is a general guideline only. Salaries are commensurate with experience and qualifications, as well as market and business considerations. Salary transparency pay range for the Washington, DC area: $130k-160k

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