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, Vaccines and Therapeutics Division (CBM).
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 and cGMP processes;
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.
Active/current Secret Clearance required.
Doctorate plus 15 years of experience or Master of Science plus 18 years of relevant experience in one of the following relevant disciplines: biomedical engineering, microbiology, immunology, toxicology, biochemistry, pharmaceutical/medicinal chemistry, molecular biology, pharmacology, genetics, virology, pathology, physiology, or similar discipline.
Experience with process development, manufacturing development and/or clinical development.
Detailed knowledge of and practical experience with FDA regulatory requirements for pre-clinical through Phase I clinical trials.
Excellent communication skills for interface with customers and with team members.
Familiarity with FDA approval/licensure requirements and processes, including the implications of the FDA’s Animal Rule guidance.
Familiarity with animal models used in drug development.
Practical experience and/or detailed understanding of the Animal Rule and associated guidance.
Experience overlapping multiple disciplines.
Familiarity with portfolio management.
Understanding of the advanced development processes (PD, CD).
Understanding of government contracting and acquisition processes.
Familiarity with scientific program development, planning, programming and reporting.
Project Management Professional certification from PMI or equivalent experience.
SAIC is a premier technology integrator, solving our nation’s most complex modernization and systems engineering challenges across the defense, space, federal civilian, and intelligence markets. Our robust portfolio of offerings includes high-end solutions in systems engineering and integration; enterprise IT, including cloud services; cyber; software; advanced analytics and simulation; and training. We are a team of 23,000 strong driven by mission, united purpose, and inspired by opportunity. Headquartered in Reston, Virginia, SAIC has annual revenues of approximately $6.5 billion. For more information, visit saic.com. For information on the benefits SAIC offers, see Working at SAIC. EOE AA M/F/Vet/Disability