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.

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 end-user, requirements community and industry to ensure equipment and supplies within assemblages are still available for procurement and capable of meeting user needs.Collaborated with advanced developer to transition new products into sustainment phase of acquisition lifecycle.Coordinated fielding and disposition of medical assemblages with Army depots and fielding units.Provided weekly updates to leadership on status of managed assemblages through written or verbal means.

•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•Facilitates review of documents intended for Food and Drug Administration (FDA) Investigational New Drug (IND) submission•Provides technical support as required•Co-lead of multi-agency working group and Integrated Product Team (IPT) •Acted as Assistant Vaccine Manager (AVM) for Filovirus Vaccine Program•Served as acting Associate Program Manager for Filovirus Vaccine Program for 3 month period•Assisted in the planning and coordination of a government, industry and academic multiday Filovirus workshop•Has completed DAU courses for Program Management Level 1 Certifiable, currently pursuing Level 2 Certifiable.

• 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 records and resulting data to ensure complete study files. Analyzes data and prepares reports for submission to FDA. • 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. • Supports medical or advanced animal research, including Animal Rule Studies, by assisting GLP compliant studies of investigational specimens from these studies, as an optional requirement. • Supports Special Immunizations Program by assisting GLP compliant studies for potency testing of clinical research materials. • Ensures that integrity of the data and the quality of all studies meets acceptable quality levels, to include tracking and storage of investigational materials.

•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 aerosol conditions for agent being tested. •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. •Received training on ISO 17025 regulations and auditing.

•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. •Received DoJ clearance for working with select agents. •Attended training at CDC for LRN molecular testing.

•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.