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Click here or scroll down to respond to this candidate Candidate's Name
4 Sheppard Lane Sykesville, MD Street Address
EMAIL AVAILABLEPHONE NUMBER AVAILABLEWorking experiences and knowledge summary: Public health policies against biological and chemical weapons of mass destruction,infectious diseases and One Health threats. DHS and DOJ programmatic and acquisition management of domestic and global security technology and biodetection research programs against WMD threats. FDA oncology research and partnership strategies; CDC and USDA regulations, safety guidelines, antibiotic resistance studies from human, food, water and environmental samples. DOD and private pharmaceutical companies execution of clinical trials for investigational vaccines, drugs and devices. Communications, project management, coordination, planning, logistical analysis.2022 to present Brillient Corporation (Remote)Research Project Manager
Proposed and got management approval for the creation and implementation of an internal Research Sharepoint Repository system and additional public accessible Plain Language Summaries website to help improve research and strategic process communications.
Drafted, sent solicitation letters to both Directors/ Supervisors for their initial approval and subsequently recommended Subject Matter Experts to review Oncology projects, contracts and grants proposals.
Drafted and log in project (s) specific information in the human subject protection portal for review and approval.
Drafted short protocols detailing OCE Research and Strategies Partnership policies and procedures.
Set up meeting calls and request agenda items.2021 to 2022 LMI (Remote)Sr.Consultant Drafted revisions to clinical documents incorporating updates on COVID-19 therapeutic products and guidance set by the FDA, NIH and pharmaceutical companies. Contributed to the team s briefing and slide presentations. Wrote standard operating procedures and developed a CMS reimbursement coding table.
Developed the team s implementation sharepoint document storage portal.
Provided support to team members on specific taskers.2018 to 2021 ANSER (Pentagon/ Falls Church, VA)
Sr. Technical Analyst
Drafted report from Joint Forces documents and Congressional briefs for DoD Joint Intermediate Force Capability Office non-lethal weapons investment program. Organized and analyzed local and international vendor responses surveys for the State Department s Cooperative Threat Reduction programs. Participated in the PHEMCE and Executive Order s strategic planning, capability-based assessments and policy development for medical countermeasures
Responsible for the drafting and submission of CBDP Leadership approved briefs to the Global Health Enterprise Council for the Ebola Virus Disease Technical Working Group. Increased information awareness through identification of research opportunities in the ChemBioRadNuc space with emphasis on national security and public health activities.2016 to 2018 Noblis (Washington, DC)Consultant
Managed the budgetary, financial trackers, project reports for Department of Homeland Security/Federal Bureau of Investigation Bio and Chem Forensics and BioSurveillance technology programs.
Identified numerous reporting and submission problems. Resolved over 90% of payment/reimbursement issues.
Performed comprehensive review and submitted procurement requisition packages for contracting.
Drafted briefing slides, responses to delegated DHS HSARPA taskers, distributed meeting minutes, monitored manuscripts and copyright application for DHS approval.
Functioned as the program communicator between the government sponsors, national security collaborators and performer(s) on project-related issues.2014 to 2016 PWPRICE Consulting (Pikesville, MD)Consultant
Provided technical expertise on specific laboratory diagnostic assays. Assisted in the technical review of microbiological, serological, and molecular diagnostic assays as supporting documentation for grant proposals. Provided regulatory guidance on the manufacturing of investigational vaccines and therapeutics.2013 to 2014 Food and Drug Administration (Silver Spring, MD)Consumer Safety Officer
Performed inspection on domestic and foreign manufacturing facilities for drugs, medical and food products to ensure conformance to safe and quality production practices. Reviewed manufacturing documents, product labeling, inspection/audit reports, recalls, premarket and post-market practices to determine compliance to FDA regulations. Investigated manufactured product deviations, out-of-specification results, market recalls,
complaints and other adverse health reports. Monitored corrective actions implementation.2012 to 2013 Goldbelt Raven (Frederick, MD)Science Manager
Functioned as Knowledge Manager for the Chemical Biological Medical Systems-Medical Identification Treatment Systems Medical Radiation Countermeasures program. Populated documents in relevant Sharepoint folders.
Participated as Project Coordination Team member in the CBMS-Biomedical Advanced Research and Development (BARDA) Interagency Agreement (IAA) scientific studies to develop project plans. Developed briefs, memos and other deliverables required by the CBMS Front Office and Joint Program Executive Office headquarters.2010 to 2012 ClinicalRM (Frederick, MD)Product Compliance Specialist
Provided technical support to US Army Medical Materiel Development Activity Clinical Support Division in the oversight of investigational vaccines, antibiotics and supplements. Conducted site visits, implemented standards into pre-clinical/ clinical data, CMC and relevant trial site qualifications needed for FDA Investigational New Drug application. Developed and maintained the database containing vaccine manufacturing information, pre-clinical, clinical and stability testing results, storage and product inventory. Provided regulatory assistance to local distributor and storage facilities to ensure that product labeling translation from Japanese to English language conformed to federal requirements.2008 to 2010 SRA International (Atlanta, GA)Technical Reviewer/Laboratory Inspector
Functioned as the Technical Reviewer of the HHS Centers for Disease Control s Select Agent Program for the importation and transfer of etiologic agents and other biological materials. Identified over 85% of common unreported transfer issues.
Consulted with senior management, legal counsel, IT, etc. in the development of policies and guidelines needed in the regulatory oversight and information dissemination. Audited and inspected laboratories to ensure the efficiency of the facility's biosafety and security plans, personnel training, and emergency procedures. Monitored implemented corrective mechanisms to mitigate non- compliance.2003 to 2008 US Department of Agriculture (Athens, GA)Biological Science Technician
Performed detection techniques for the identification of bacterial strains, antibiotic resistance genes and plasmids from chicken rinsates and environmental isolates. Conducted special projects to ensure delivery of verifiable and sound technical data in support of the department s quality requirements. Presented results in meetings, assisted in the publications on the epidemiological collaborative studies with the CDC PULSENET surveillance group.
2000 to 2003 Atlantic Scientific Development (Plantation, FL)Biotechnology Research Technologist
Developed the methodology for the field collection and processing of biological threat agents using different filtration, bacteriological and serological procedures. Manufactured optimized collection/ detection kits and shipped to collaborating federal agencies. Functioned as the Laboratory Manager in the evaluation and purchasing of laboratory materials and equipment.
Wrote standard operating procedures and related protocols according to GLP and GMP standardsEducation:Fairleigh Dickinson University
Masters, Biology
Training & Certifications:Medical Technologist (ASCP), DAU Acquisition courses, CDC Biosafety LevelClearance:TS/SCI |
