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 emerging applications 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.
* 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.
Associated topics: bioengineering, biological engineer, biology, biomaterials, bioprocessing, biosynthetic, fermentation, msat, neuro, pathogenesis