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Chemical & Biological Defense Therapeutics Development Scientist Lorton, VA

Watermark Risk Management International has an exciting opportunity for 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 with the Defense Threat Reduction Agency (DTRA) Chemical and Biological (CB) Department, Vaccines and Therapeutics Division (CBM).

The selected candidate will join a multidisciplinary team providing scientific analysis, project oversight and budgeting and or acquisition assistance on a variety of current and emerging applications addressing concerns in the area of therapeutic countermeasure development for biological warfare defense.

Requirements:

• 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)
• Detailed knowledge of and practical experience with Food and Drug Administration (FDA) regulatory requirements for pre-clinical through Phase I Clinical trials
• Excellent communication skills for interface with customers and with team members

In this role you 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

Education:

• Bachelor of Science plus 14 years of relevant experience, Master of Science plus 12 years of relevant or Doctorate plus 9 years of experience in one of the following disciplines: microbiology, immunology, toxicology, biochemistry, pharmaceutical and or medicinal chemistry, molecular biology, pharmacology, genetics, virology, pathology, physiology, biostatistics, or similar discipline

Security Clearance:

• Active and or current Secret Clearance required

Preferred Qualifications:

• Familiarity with FDA approval and or 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

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