Former FDA Consultant


Two years as owner, TCubed Regulatory Consulting, LLC, performing Biologics focused consulting services for pharmaceutical manufacturing/CGMP compliance.  

Previously, sixteen years FDA regulatory review, inspection, and project management experience in both the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, to include management experience in the Center for Biologics (Team Leader), Office of Compliance and Product Quality, Division of Manufacturing and Product Quality.  The latter experience covers all aspects of CGMP, facilities, equipment review, and inspections for products regulated by the Center for Biologics. Service included duties as the final secondary reviewer for all memoranda generated by Branch Review staff. Was the recognized senior subject matter expert for several functional review areas, to include container closure integrity, aseptic processing, environmental monitoring, lyophilization validation, and cleaning validation.  Participated in 20 Pre-Approval inspections, and was the lead inspector for 15 of these. The various positions included working with nearly all major pharmaceutical manufacturers, and numerous minor firms. Previous experience in vaccine/molecular biology based research at the United States Army Research Institute of Infectious Diseases.


Colorado State University, Fort Collins, CO

B.S., Biology, Minor, Human Anatomy, December 1988

Hood College, Frederick, MD

M.S., Biomedical Sciences, September 1998





March 2015 to Present


  • Review of all aspects of CGMP compliance aspects with a focus on Biologic Drug Products
  • Performance of mock prior approval CGMP inspections
  • Evaluation of compliance status, quality systems functionality, equipment validation status
  • Drafting and/or Evaluation of Regulatory Documentation, such as FDA/Industry Meeting Backgrounders, and all BLA submissions relating to facility implementation/changes
  • Acquisition due diligence activities resulting in multi-billion dollar corporate purchases
  • Twenty current active contracts with pharmaceutical manufacturing firms, to include work that spans the entire range of CGMP activities, as well as regulatory review aspects pertinent to Module 3 of the eCTD.


Team Leader, Supervisory, Manufacturing Review Branch II,

Food and Drug Administration, Center for Biologics Evaluation and Research, 

Office of Compliance and Biologics Quality,

Division of Manufacturing and Product Quality

February 2013 to March 2015


  • Senior technical advisor for the Branch for all product types regulated by CBER, with a focus on viral vaccines and blood fractionation products
  • Performs secondary management review and sign off for nearly all review memoranda generated by the Branch
  • Leads review and inspection teams for numerous BLAs and BLA supplements (> 250), regulatory meetings, and other regulatory submissions (IND, DMF, 510k, PMA, ANDA, etc.) and consistently provides technical training to staff; trains and certifies new inspectors
  • Interacts with regulated industry to identify areas of weakness and to identify best paths to solutions
  • Branch Chief in his/her absence or as delegated
  • Mentors, assists, and provides consultation to reviewers on their assignments
  • Authorship and participation in formulation of Division, Office, Center, and Agency level documents for technical accuracy and consistency with applicable guidance with respect to regulations, CBER policy, and current thinking
  • Instituted changes in the way the Division reviews applications for Container Closure Integrity, Lyophilization, and Equipment Cleaning Validation
  • Developed aspects of the Division training curriculum based on Branch training requirements; provides Division, Office and Center level training talks as necessary 
  • Is the Division subject matter expert for Lyophilization, Container Closure Integrity, and Cleaning Validation, Environmental Monitoring and Barrier Isolation, and is extremely competent in all other aspects of CGMP review
  • Provides Division, Office and Center level representation at external meetings and conferences; presents applicable talks as necessary
    • ISPE, PDA, and IBC presentations on Barrier Isolation, Container Closure Integrity, Single Use materials

Senior Reviewer, Non-Supervisory, Manufacturing Review Branch II

Food and Drug Administration, 

Center for Biologics Evaluation and Research, 

Office of Compliance and Biologics Quality,

Division of Manufacturing and Product Quality

March 2007 to February 2013


  • Serves as the Branch Chief and/or Team Leader in his/her absence or as delegated
  • Review of manufacturing information submitted in CMC section of biologic license applications and supplements (BLAs)
  • Conduct of pre-approval inspections for new biologics drug sponsors
  • Review of investigational new drug submissions, compliance actions arising from biennial post-licensure inspection of biopharmaceutical firms  
  • Assist in development and implementation of regulatory policy for all aspects of facilities and equipment review performed at DMPQ
  • Mentor junior reviewers/inspectors

Reviewer/Reviewer Trainee, Manufacturing Review Branch II

Food and Drug Administration, 

Center for Biologics Evaluation and Research, 

Office of Compliance and Biologics Quality,

Division of Manufacturing and Product Quality

July 2005 to March 2007


  • Similar to those described for the above time period when beyond trainee status

Senior Regulatory Health Project Manager,

  Food and Drug Administration, 

Center for Drug Evaluation and Research, 

Division of Antiviral Drug Products, Rockville, MD.  

March 1999 – July 2005.  


  • Managed multi-disciplinary teams to facilitate the evaluation and regulation of investigational new drug products and approved drugs
  • Completed regulatory review and analysis of Investigational New Drug Applications and New Drug Applications
  • Responsible for the planning, coordination, and orchestration of timely reviews of regulatory submissions
  • Was the regulatory expert on drug review teams, and provided regulatory guidance as the primary liaison with the pharmaceutical industry and other external constituents
  • Pursued continued learning in courses and meetings to broaden understanding of drug development and drug review processes
  • Gave input and implemented DAVDP procedures and policies as the Smallpox drug development project manager-Identification and assessment of emerging complex issues relating to smallpox drug development as well as serves as liaison to industry, the CDC, the NIH and the DoD for guidance on smallpox drug development issues
  • Pre IND counter-bioterrorism project manager
  • Divisional Office of Information Technology (OIT) liaison
  • Mentored new project managers


Non-FDA/USPHS Employment:

Senior Research Assistant, Antex Biologics, Germantown, MD

  • Bacterial Vaccine Research/Molecular Biology

November 1997 to March 1999


Non Commissioned Officer In Charge, Virology Division

USAMRIID, Ft. Detrick, MD (Army Active Duty)

January 1997 to-November 1997 


Senior Non Commissioned Officer, Molecular Virology

Section, Virology Division

USAMRIID, Ft. Detrick, MD (Army Active Duty)

May 1993-January 1997 


General duties during Army Assignment:


  • Supervised up to 17 personnel in all aspects of laboratory operations.
  • Supervised highly complex tests performed by all laboratory personnel
  • Evaluated annually the competency of the staff to perform test procedures 
  • Provided orientation and training to military, civilian, and student employees 
  • Drafted research proposals, project plans, and standard operating procedures
  • Organized and established the work site for radioactive usage and sterile conditions for tissue culture
  • Supervised and performed complex tests for microbiology and molecular biology assays

Biomedical Research:

  • Designed and carried out all manner of molecular biology and microbiological assays and research, to include but not limited to the following:
    • Growth & maintenance of aerobic & anaerobic clinical & environmental bacterial isolates
    • Aseptic technique & sterilization
    • Maintained laboratory records and laboratory Standard Operating Procedures
    • In vivo & in vitro staining/imaging of single cell organisms
    • Bacterial phenotypic, physiologic & genetic microbial characterization
    • Single cell isolation from human samples using mechanical & culturing techniques
    • Serological, EIA & Southern Blot, Western Blot assays, microbial toxin and viral detections 
    • Electron/Fluorescent microscopy (SEM/TEM) operation & sample prep/stain



  • Commendation Medal (2010)
  • Outstanding Unit Citation (2009)
  • PHS Unit Commendation, Gulf Hurricanes Response Team (2007)
  • Outstanding Unit Citation (2007)
  • Crisis Response Service Award (2006)
  • PHS Unit Commendation (2005)
  • PHS Unit Commendation (2005)
  • Outstanding Unit Citation (2004) 
  • PHS Unit Commendation (2003)
  • Commendation Medal (2002)


Other Awards (Agency and Uniformed Services Awards)

  • FDA Agency Group Recognition Award (2004)
  • Meritorious Service Medal, U.S. Army (1997)
  • Commendation Medal, U.S. Army (1997)


REFERENCES: Available upon request

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