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SAIC Chemical & Biological Defense Therapeutic Scientist in LORTON, Virginia

Description

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).

Qualifications

  • 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.

#DTRA

Desired Qualifications

  • 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.

REQNUMBER: engility-190897

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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