SAIC is seeking a qualified Chemical & Biological Defense Biomedical Engineer / Scientist with industry experience in research and development with an emphasis on quality assurance and FDA regulatory compliance. The candidate will support the Advisory and Analysis Services (A&AS) contract with the Defense Threat Reduction Agency (DTRA) Chemical and Biological (CB) Department.
This work is located in Lorton, VA.
The successful candidate, as a Subject Matter Expert (SME), will:
· Provide A&AS support to the Government with Medical Science, Quality Assurance and FDA Regulatory compliance;
· Possess extensive knowledge of US FDA regulations and standards, especially relating to pre-clinical and pre-IND manufacturing, cGMP processes, and/or design and execution of Phase I Clinical Trials;
· Review and provide written and verbal guidance to Science and Technology Managers (STMs) on scientific proposals’ suitability for funding;
· Produce written technical analyses of the rationale, estimates and information behind proposed costs for proposals submitted by academic, military, and industrial laboratories;
· Review and provide regulatory guidance to STMs on reports and data packages provided by contracted organizations and government laboratories on the progress of funded research (cost, schedule and performance);
· Provide advice on courses of action and assist with preparation of reports and briefings to senior government officials;
· Participate in coordinating interdepartmental activities and research efforts;
· Assist government staff with drafting critical documents and responding to taskers;
· Maintain current understanding of the rapidly evolving scientific advancements relevant to the Team's portfolio of projects and advise government staff on advancements.