SAIC Chemical & Biological Defense Therapeutic Scientist in LORTON, Virginia
SAIC is seeking a qualified Chemical & Biological Defense Therapeutic Development Scientist with industry experience in antibiotic and antiviral research and development with an emphasis on small molecule drug development for the Advisory and Analysis Services (A&AS) contract supporting the Defense Threat Reduction Agency (DTRA) Chemical and Biological (CB) Department, Vaccines and Therapeutics Division (CBM).
This work is located in Lorton, VA.
The selected candidate will join a multidisciplinary team providing scientific analysis, project oversight and budgeting/acquisition assistance on a variety of current and emergingapplications addressing concerns in the area of therapeutic countermeasure development for biological warfare defense.
The successful candidate, as a Subject Matter Expert (SME), will:
Evaluate and provide expertise on all aspects of therapeutic research and development, including project design, development, execution, and implementation;
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 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 Therapeutics Team's portfolio of projects and advise government staff on advancements
Direct experience in commercial pharmaceutical development.
Conversant and familiar with tasks and best practices as they relate to: Pharmacology, Toxicology Profiling (GLP), risk mitigation and requisites for IND submissions, Chemistry Manufacturing and Controls (CMC) (cGMP) and conduct of clinical evaluations (GCP).
Active/current Secret Clearance required.
Doctorate plus 9 years of experience or Master of Science plus 12 years of relevant experience in one of the following relevant disciplines: microbiology, immunology, toxicology, biochemistry, pharmaceutical/medicinal chemistry, molecular biology, pharmacology, genetics, virology, pathology, physiology, biostatistics, 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.
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
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