Consultant, Biologics Consulting Group, Inc.
Alexandria, VA

Information Technology Specialist, FDA, Center for Biologics Evaluation and Research, Office of Information Management, Rockville, MD

• Technical lead for the CBER electronic submissions program.
  
• System administrator of the Electronic Document Room (EDR) and secure e-mail infrastructure.
  
• Involved in the joint CBER/CDER development of a processing and review system (EVS) for eCTD submissions.
  
• Quality control and loading of eIND, eBLA and eCTD submissions into the EDR and EVS.
  
• Made panel presentations regarding the CBER electronic submissions program at DIA conferences.
  
• Provided daily support and periodic training to CBER staff regarding electronic submissions review.
  
• Technical editing of electronic submissions guidance documents.
• Comprehensive review of demonstration eIND and eBLA applications submitted by industry.
  
• Assisted industry in establishing secure encrypted e-mail communications with CBER through the use of SMIME certificates or SPN connections.
  
• Provided technical solutions to CBER staff and industry regarding problems with electronic submissions.

Biologist, FDA, Center for Biologics Evaluation and Research, Division of Viral Products, Bethesda, MD

• Chaired and served on review committees for numerous PLA, ELA, BLA and IND submissions.
  
• Performed hemagglutination inhibition (HI) serological tests in support of yearly influenza vaccine strain selections.
  
• Made presentations of serology results at FDA Advisory committee meetings.
  
• Responsible for strain identity, potency (SRID) and inactivation tests of influenza vaccine.
  
• Produced high yield reassortant influenza viruses for use in vaccine manufacture.
  
• Implemented an automated data collection and calculation system for SRID testing.
  

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