David Bailey Email & Phone Number

Aberdeen Proving Ground, Maryland, US

Aberdeen Proving Ground, Maryland, US

Silver Spring, MD, US

Reviewer with CBER/OCBQ/DMPQ for new biologics applications and supplements focusing on CMC and facility information. Conduct pre-approval and pre-license inspections of manufacturing facilities.

Arlington, Virginia, US

Medical Device Assemblage Management Product manager for 105 U.S. Army medical assemblages. Assemblages consist of medical equipment, disposable and durable supplies.Chaired Working Group tasked with determination of Life Cycle Cost estimate for a potential new Army physical therapy initiative and development of new Army combat medic field set. Worked with.

Arlington, Virginia, US

Alexandria, Virginia, US

• Acting Associate Program Manager for Ricin Vaccine Program and new start vaccine programs.
• Developing Transitional Teaming working groups between DTRA-JSTO and MCS-JVAP
• Assists in daily program management of advanced development vaccine acquisition program, tracking cost, schedule and performance
• Utilizes Microsoft Project Gantt charts to track multiple ongoing studies across multiple sites and performers
• Assists in financial planning for Program Objective Memorandum (POM)
• Develops work plans and Statements of Work (SOW)/Statements of Objective (SOO) for non-clinical studies at several high level containment laboratories

• Carry out regulated GLP studies. Support a variety of laboratory-based activities associated with FDA regulatory compliance, analytical method optimization & validation.
• BSL-3 laboratory manager
• GLP Non-Clinical Regulated Study Director
• Develops standard operating procedures (SOPs) study-specific procedures (SSP), etc. to ensure compliance with Good Laboratory Practices (GLP) regulation.
• Review protocols, study plans, and associated documentation to support research and development projects under GLP for products regulated by the Food and Drug Administration (FDA). Organizes and tabulates laboratory.
• Perform laboratory quality management activities for supported customers to the required quality standard. Supports analytical method validation studies to support use in FDA-regulated studies.

• Received training in Aerobiology Department. Work included Class III BSC, setting up aerosol samplers (AGI, SKC, ect.),utilizing airlock for transfer of samples into and out of the aerosol chamber and optimizing.
• Conducted microbiology assays on Select Agents at BSL-4 level containment. Served as BSL-4 bacteriology mentor and assisted in training of additional staff members.
• Served as BSL-3 bacteriology mentor and the Laboratory Space Manager. Included managing equipment maintenance and calibrations, training staff, ensuring the laboratory meets all biosurety and biosafety standards.
• Assist in project planning for studies conducted at NBACC.
• Successfully developed a pharmaceutical milling project, including developing SOPs, performing biosafety assessments and training other staff.
• Acquired DoJ select agent clearance, DoD Top Secret clearance, Department of Homeland Security Suitability, currently enrolled in the Personal Reliability Program and serve as a Select Agent Custodian.

Columbus, Ohio, US

• Conducted microbiological assays in a BSL-3 level laboratory with various bacterial and viral Select Agents. Assays included: bacterial growth, animal studies, ELISA, viral propagation and harvest.
• Performed pre and post quantification of bacterial agents used in Aerosol studies. Some work in Class III BSC assisting Aerosol technicians.
• Developed SOPs for an in-house pipette calibration system.
• Conducted all laboratory experiments according to GLP regulations and ISO 9001 standards.
• Performed Quality Assurance checks of other technicians’ work to ensure compliance.
• Acquired DoJ select agent clearance and DoD Secret clearance. Underwent Single Scope Background Investigation for entry to Biological Personnel Reliability Program.

• Conducted PCR assays and DNA sequencing analysis of clinical samples. Other duties include cell culture and DNA extraction.
• Maintained patient data database. Prepared analysis reports for presentation to the medical director. QA/QC of reports written by other technicians.

• Conducted CDC Laboratory Response Network protocols for real-time PCR, real-time RT-PCR, and culture based methods for detection of bioterrorism agents. Maintained the containment laboratory at 24/7 readiness.
• Developed real-time RT-PCR assays for Influenza A and B, Norovirus and real-time PCR for B. pertussis. Trained on Nuclisense automated DNA/RNA extractor, NASBA detection system, and ELISA for arbovirus.
• Developed and implemented protocols for new laboratory procedures. Revised safety manual.
• Managed laboratory finances and purchasing.
• Supervised and trained other staff members.
• Other duties involved developing an interagency workgroup dealing with CBRNE, natural disaster and disease events. Active participant in state pandemic influenza planning committee.

• Conducted Pulsed-Field Gel Electrophoresis, PCR, real-time PCR and Pyrosequencing for use in a bacterial source tracking project.
• Managed lab supplies, media and reagent preparations, assisted in data analysis and interpretation.
• Developed and maintained an Excel database of all environmental samples received.
• Participated in a USGS study of bacterial contamination of watersheds as related to waste treatment plants’ TMDLs.
• Management of research grants finances and purchasing.
• Supervised other technicians and graduate assistants.

Masters Of Professional Studies, Homeland Security Public Health Preparedness

Bachelors Of Science, Microbiology