Biomedical Engineer / Scientist - Military veterans preferred

2019-04-12
SAIC (www.saic.com)
Other

/yr

  full-time   employee


Lorton
Virginia
22079
United States

Description

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.

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, cGMP processes, and/or design and execution of Phase I Clinical Trials;

·         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.


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: biomedical, medicinal chemistry or closely related science 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.


Desired Qualifications

 

  •     Regulatory Affairs Certification (RAC).
  •      Prior experience working with or for the FDA on drug approval.
  •      Prior experience with the development of animal models used in drug development.
  •     Familiarity with portfolio management.
  •     Understanding of the advanced development processes.
  •     Understanding of government contracting and acquisition processes.
  •     Familiarity with scientific program development, planning, programming and reporting.