Debra L. Bratt (Debbie)

Woodsboro, Maryland (**798) /ad18kf@r.postjobfree.com / US. Citizen / Security Clearance: Public Trust / Schedule A Disability / Hours Per Week: 40 /www.linkedin.com/in/debbie-bratt

EDUCATION

BACHELOR’S DEGREE: BIOLOGICAL ANTHROPOLOGY PRIMATES PRE-MEDICINE UNIVERSITY OF WASHINGTON

POST BACCALAUREATE CLASSES IN EPIDEMIOLOGY, MICROBIOLOGY, PUBLIC HEALTH, GENETICS AND LAW UNIVERSITY OF WASHINGTON

OBJECTIVE

Methodical and adaptable Sr. Scientific Research Program Manager with 20+ years of experience in planning, developing, evaluating, and managing biomedical and public health programs, employee and team management, the life cycle of research and funding, policies, and procedures. A collaborative, initiative-taking, and dependable leader skilled in providing leadership and direction for high-profile projects and programs. Expert in evaluating, assessing, and formulating overall procedures and policies for program management, serving as a liaison among various stakeholders, including national and international public health, research, clinical, medical, regulatory, and environmental health organizations, government agencies, academic institutions, and health departments, and implementing management for improvement and appropriate controls. Possesses extensive knowledge of agency mission, policies, objectives, and management principles and processes, enabling effective communication and influence over program sponsors, customers, employees and other stakeholders. Thirsty to continue serving as a senior public health advisor/manager who coordinates programs by providing leadership in planning, policy, budgeting, and regulatory frameworks and seeking to leverage my expertise in scientific research program management, the federal government know-how, portfolio management, policy analysis, data compilation, employee management, technical work requirements, milestones, remarkable interpersonal skills, and strategic planning to support the federal government amelioration of public health diseases and facilitating the research of the future.

PROFESSIONAL EXPERIENCE

PROGRAM MANAGER II 01/2023 - 09/2023

ATCC-Federal Solutions / Gaithersburg, MD /

Hours per week: 40

MISSION STATEMENT: ATCC is the premier global biological materials resource and standards organization whose mission focuses on the acquisition, authentication, production, preservation, development, and distribution of standard reference microorganisms, cell lines, and other materials.

PROGRAM MANAGEMENT: Conducted qualitative and quantitative assessments to recommend program growth and improve critical program effectiveness. Managed complex technical/scientific programs, ensuring productivity and efficiency through planning and scheduling. Developed presentations and reports for program evaluations, risk management, and budgetary oversight. Being part of senior management, effectively provided comprehensive project papers, briefings, and staff reporting for senior leadership. Utilized fact-finding, research and investigative techniques to review new policies and their impact on program processes and organizational efficiency.

BUSINESS DEVELOPMENT: Identify and recommend opportunities for program growth by curating new business development pipelines, capture management, acquisition, and proposal writing for the National Institute of Health (NIH) and associated government entities to acquire governmental contracts for ATCC’s Federal Services (AFS) while reviewing current practices and recommending improvements.

FINANCIAL MANAGEMENT: Solely responsible for planning, forecasting and budgeting, resource allocation, operations and monitoring, and evaluating and reporting multi-million-dollar contracts and grants, ensuring they align with their financial status contracted, deliverables by maintaining fiscal accountability and ensuring compliance with regulations and actively instituting internal control standards, procurement standards, audit standards, reporting requirements, cost share reporting, subawards, allowable costs.

EMPLOYEE TRAINING PROGRAM: Being tasked with starting the training for all ATCC’s program managers, I assessed the organization and research capacity by providing leadership and guidance while creating and leading the Federal Contract Program Manager Training Program for all Federal Contract Program Managers employees at ATCC. The program consisted of internal and external trainers, and I aligned the training to the Program Manager’s daily duties. Always Motivating, leading, and coaching staff to ensure effective management of Federal Programs.

KEY ACHIEVEMENTS:

I managed the High Containment Facility (HCF) Renovation grant, which is biosafety level (2+, 3), meeting all milestones and keeping the construction on track. Proposal design, technical writing, and submission of two funded contracts:

1.Awarded NIH funding for constructing a large-scale biomedical suite within ATCC’s new HCF, for a large-scale production suite to produce countermeasures against infectious diseases of pandemic potential. ($8 million)

2.NIH’s Vaccine Research Center (VRC) central repository for NIH’s precious biomaterials (IDIQ- Base + 7 option years) ($5 million).

PROFESSIONAL EXPERIENCE

SCIENTIFIC PROGRAM MANAGER 05/2021 – 01/2023

NIAID / Department of Microbiology & Infectious Diseases / Respiratory Branch Division / Viral Section via CAMRIS/ Hybrid Rockville, MD /

Hours per week: 40

MISSION STATEMENT: NIAID’s Vision for The Division of Microbiology and Infectious Diseases (DMID) is to support extramural research to control and prevent diseases by virtually all human infectious agents except HIV. DMID provides funding opportunities and a comprehensive set of resources for researchers that support basic research, preclinical development, and clinical evaluation.

PROGRAM MANAGEMENT: Tailored program management strategies for government-funded infectious disease initiatives aligned with agency policies and objectives. Directed research, funding, facilitating operations, understanding long-term goals, adapting to emergent/evolving data, science, and innovative new processes with excellent communication, and producing timely sound science for the US Government to determine what is needed for the public health during the ongoing COVID-19 pandemic.

PROJECT MANAGEMENT: Inspire dynamic, collaborative, and cross-functional relationships with a culture of inclusion and collaboration. Provided comprehensive scientific, research, and administrative project management support for a variety of research for public health-related programs. Served as Subject Matter Expert (SME) and an advisor on infectious disease respiratory program development, execution, and evaluation, aligning with agency mission and objectives and recruited on a high priority basis by NIAID during SARS-CoV-2 Assessment of Viral Evolution (SAVE) and the established Centers of Excellence for Influenza Research and Response (CEIRR) programs, and their subsequent subcontracts.

DATA MANAGEMENT: Led cross-functional teams in the collection, analysis, and synthesis of complex scientific data. In a demanding, rapid response environment, these data streams provide vital information for USG to make recommendations on current and future influenza and COVID-19 vaccines. Provided expert-quality formal and informal data, studies, reports, briefings, analyses, and prepared project papers, responses, and staff reports for senior management and White House reports.

Facilitated, maintained, analyzed, synthesized, evaluated, tracked, and developed data (Twitter), data management processes, and databases for internal and external researchers where we could disseminate information (funding opportunities, program announcements, SOPs, forms, templates, surveys, documents, reagent management literature reviews, publications, log variants, antibodies and proteins, etc.) and receive information (Reports, Deliverables, proposals, data, and other required information).

ORGANIZATIONAL MANAGEMENT: Meet organizational deadlines in a rapid response environment for scheduled updates, publications, risk factors, and finances. Organized and conducted workshops, conferences, symposia, or similar activities to foster the program's aims in a pandemic with finite rules. My ability to establish, maintain and repair effective work relationships with individuals at every level has set me apart from almost every program manager.

COMMUNICATION AND INTRAPERSONAL RELATIONSHIPS: Coordinated with stakeholders to ensure compliance with management principles and fostered efficient program operations. Served as a liaison, coordinating research efforts and applying fact-finding techniques to support program development and execution. Coordination of internal and external federal agencies and academia laboratories, corporations, international teams of scientists, officials, and advisors. Ensuring compliance with federal, state, and local safety regulations. Delicately working with investigators to tackle highly volatile policy issues like gain of function and dual-use research of concern. Skilled in oral, written, and graphic communications (PPT and web design) by actively gathering and disseminating information to appropriate parties.

KEY ACHIEVEMENTS: Being a part of SAVE management is the highlight of my career. Collaborating in an open sharing environment in real-time amongst the field's very best scientists is a true dream come true. The impact of open sharing and collaboration is something I have always hoped for as a scientist, and we did it. I bring this to every new challenge, program, and project.

1.SAVE-NIAID's 'Avenger-Like' Research Program for Evolving Pathogens

2.Defining the risk of SARS-CoV-2 variants on immune protection

PROFESSIONAL EXPERIENCE

SCIENTIFIC & RESEARCH PROGRAM MANAGER 07/2020 – 05/2021

Center for Vaccine and Immunology (CVI) / College of Veterinary Medicine (CVM) / University of Georgia (UGA) / Athens, GA /

Hours per week: 40

MISSION STATEMENT for the Center for Vaccines and Immunology (CVI) is to improve human and animal health by bringing together vaccine researchers at the University of Georgia and helping them identify opportunities for collaboration, providing an intellectual environment for discovery, and producing novel vaccine technology.

PROGRAM MANAGEMENT: Proven expertise in applying analytical and evaluative methods and techniques to assess program development and improve organizational effectiveness and efficiency. Familiar with budgetary and financial management principles and techniques essential for long-range planning of programs and objectives. Skilled in fact-finding, investigative techniques, and developing comprehensive presentations and reports.

PROJECT MANAGEMENT: Managed the inception and execution of high-risk population clinical research programs, applying evaluative techniques to measure success. Coordinated with stakeholders to ensure compliance with management principles and fostered efficient program operations. Projects included the rapid creation of the government-mandated pandemic pre-clinical study:

1.The SARS SeroPrevelance and Respiratory Tract Assessment (SPARTA) study

Management of the following studies:

2.Animal Health Research Center (ARCH) (BSL4) cynomolgus vaccine project.

3.Collaborative Influenza Vaccine Innovation Centers (CIVIC)

4.Indo-European Consortium for Next Generation Influenza Vaccine Innovation (INCENTIVE)

CLINICAL DATA MANAGEMENT: Analyzed and evaluated quantitative and qualitative data to provide real-time qualitative and quantitative data to NIAID of serology of the surrounding population to understand the prevalence of the COVID-19 virus. Instated the management of the CVI's NHP Census and developed a database for project tracking, NHP tracking, Data Tracking, Regulatory Tracking, and financial tracking. Set up the management of the pre-clinical and clinical sampling.

EMPLOYEE MANAGEMENT: Managed the SPARTA studies, clinical staff, research employees, and participants. Implementing modernization and integration processes for hiring and onboarding personnel. Applying knowledge of management tools and procedures to increase technical and organizational goals, skillsets and capacities. Retaining employees, ensuring employee and patient safety during the height of the pandemic.

SUBJECT MATTER EXPERT: In intra-personal coordination of programs, projects, and operational processes for infectious disease research, both clinical and basic, with NHPs and the federal programs listed above for the CVI. I leaned heavily on my regulatory background to ensure all staff, researchers and patients are operating in biosafe environment.

KEY ACHIEVEMENTS:

1.Vaccine Research for High-Risk Populations (CIVR-HRP) SPARTA & INCENTIVE from inception. Established the first petty cash system for study participants at UGA using the new automated system.

2.Procured NHPs for CIVIC studies by sourcing many vendors, negotiating prices, and making relations, which allowed me to implement the NHP CIVIC research design and data. Collaborated with the Leaders in NHP and infectious Disease Principal Investigators to write an NHP_Field_Guide, which provides considerations for using primate models for SARS-CoV-2 Treatments and Vaccines. *(Written during and for the COVID-19 Pandemic)

PROFESSIONAL EXPERIENCE

ASSOCIATE DIRECTOR OF RESEARCH & OPERATIONS 09/2018 – 07/2020

Non-Human Primate (NHP) Core / CVI / CVM / UGA / Athens, GA /

Hours per week: 40

MISSION STATEMENT Improve animal and human health through excellence in veterinary and biomedical education, research, and clinical service

OPERATIONS MANAGEMENT: Working closely with Senior Management, we shaped, formulated policies and standard operating procedures for the program. Offered expert managerial and technical advice on administrative/ business-related project management, developing effective procedures for departmental operations. Directed research operations, ensuring adherence to regulatory guidelines and applying investigative techniques for program advancement. In a matrixed environment, refined and developed priorities for research, laboratories, animals, medical equipment and property, biosafety, occupation health, employees, and business operations. Leading the program by organizing studies to improve the efficiency and effectiveness of all operational research. Planned, executed, and evaluated operations research daily by communicating work assignments, deadlines, and project milestones.

EMPLOYEE MANAGEMENT: Implemented and supervised the recruitment process hired, trained, and retained employees during a pandemic by refining pay, job duties, and operations. Providing leadership, team building, and guidance in managing NHPCore staff and personnel resources, ensuring alignment with employees' goals and operational and fiscal activities, timekeeping to accomplish the organization's mission, milestones both short and long-range plans. Executed executive leadership responsibilities, overseeing office staff, students, employees, and veterinarians to establish and promote diversity and engagement of all employees by facilitating financial planning and problem-solving to deliver measurable outcomes.

SCIENTIFIC MANAGEMENT: Directed the administrative, research, operations, regulatory, and staff of the newly minted UGA NHPCore by providing scientific and administrative (research, clinical, and animal) and implemented study design in NHP models for Infectious Disease Research and actively managed the scheduling of experiments, procedures, equipment, and employees by prioritizing animal needs, study projects, and procedures and providing regular oral and written instructions, reports, SOPS, and coordination with the University Administration.

BIOSAFETY MANAGEMENT: Excellent Biosafety Management, proper scientific compliance, detailed in-vivo and in-vitro research, animal welfare, Personal Protective Equipment (PPE), and Occupational Health, etc. are vital to daily operations and scientific rigor. Understanding this allowed me to push for UGA's Occupational Health policy to be updated for the NHPCore to reflect current regulations and practices for MMR screening.

FINANCIAL MANAGEMENT: Managing the NHPCore Financial management by self-auditing and frequently reviewing customer billing, pricing, and Operation Ordering allowed me to identify peak and slack periods, prompting me to pursue new scientists/projects and procure NHPs by sourcing alternate vendors, negotiating prices, and making relations, which allowed me to expand the NHPCore Species, Research, Services, and Operations. Under pandemic settings, provided alternative species to investigators by collaborating with the National Primate Research Center(s). This ultimately set UGA to explore bringing new species of monkeys to UGA. We acquired Japanese Macaques, and researchers could continue researching when NHP inventory was meager during the pandemic. Self-auditing continually and annual review of customer billing and pricing for investigators.

KEY ACHIEVEMENTS:

1.Created the Operations Manual for UGA's new NHPCore Facility and Research.

2.Updated the testing and criteria of Measles Mumps and Rubella (MMR) for Occupational Health, making UGA NHPCore and UGA Vet school up to date for MMR testing/screening, ultimately changing policy for onboarding staff.

PROFESSIONAL EXPERIENCE

CLINICAL AND BASIC SCIENCE RESEARCH MANAGER 11/2017- 09/2018

Department of Orthopaedics & Sports Medicine / Harborview / University of Washington (UW) / Seattle, WA

Hours per week: 40

MISSION STATEMENT of the University of Washington Department of Orthopaedics and Sports Medicine is committed to a culture of openness, civility, and respect, employing and training a diverse workforce (staff, residents, and faculty), and providing quality and equitable healthcare to all persons in need of our expertise. Diversity and inclusion are essential moral values. Encoding these principles in our "departmental DNA" will result in a more collegial, productive, and creative work environment, which leads to more effective teaching, research, and innovative care; within our department, all persons will find compassionate and high-quality care for any Orthopaedics condition.

CLINICAL& RESEARCH MANAGEMENT: Provided analytical support for clinical research programs, contributing to the department's strategic planning and long-range objectives. The focal point for Department management of ongoing research in the Department of Orthopaedics, both primary and clinical research. Providing basic Scientific and Administrative project management support, clinical trial management (Sports Medicine: Cartiheal Agili-C, NeoCart Phase 2 Clinical Trial, STaR Trial: Multiple Ligament Knee Injuries), oversite, site visits, and development of research plans. Regularly review the program(s) by providing evaluation and reporting to leadership about processes that need improvements. Approve/review clinical data management plans or develop essential study document templates (e.g., Data Management Handbook, Data Management Plan, Data Validation Plan, EDC System User's Guide, EDC Training and Certification Documents).

DATA MANAGEMENT: Provides oversight for determining data collection requirements at a project or therapeutic area level, utilizing experience to drive development for the management and reconciliation processes of the data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sources. Responsible for analyzing potential complex data management issues/risks and recommending and implementing solutions.

Approve/review clinical data management plans or develop essential study document templates (e.g., Data Management Handbook, Data Management Plan, Data Validation Plan, EDC System User's Guide, EDC Training and Certification Documents).

FINANCIAL MANAGEMENT: Expertise in the development and management of grants/contracts, including evaluation and refinement of statements of work, project budgets, milestones, and deliverables.

KEY ACHIEVEMENTS:

1.Successfully managed the Department of Orthopaedics Seed Grant Funding and Research Fund Allocation, Study Budget, Petty Cash, and Departmental research budget.

2.Reviewed all research programs and made recommendations on each department evaluating the risks and accomplishments of each program and project.

PROFESSIONAL EXPERIENCE

WaNPRC RESEARCH COORDINATOR & PROGRAM MANAGER / MUCOSAL IMMUNOLOGY CORE (MIC) MANAGER 01/ 2016- 11/ 2017

Washington National Primate Research Center (WaNPRC) / University of Washington (UW) / Seattle, WA

Hours per week: 40

FLOW CYTOMETRY CORE MANAGER 01/ 2014- 11/2017

SENIOR LAB MANAGER / RESEARCH SCIENTIST IV / PROJECT MANAGER 01/ 2011- 11/2017

Deb Fuller Laboratory / Washington National Primate Research Center (WaNPRC) / University of Washington (UW) / Seattle, WA Hours per week: 40

MISSION STATEMENT of the University of Washington National Primate Research Center is to empower the delivery of leading-edge scientific discoveries to improve human health while promotion the highest standards of care, health, well-being, and conservation for Primates around the world. To meet this mission, the WaNPRC strives to create a research environment that promotes diversity and inclusion within an innovative, yet well-established program for advancement of scientific discoveries and their application for improving the quality of life.

ATTENTION TO DETAIL: Leading and managing complex organizational plans allowed me to coordinate with strategic and operational plans, the project teams and business stakeholders to define the approach, activities, and timelines for project execution, leveraging project management. Focused tailoring of standard project methodologies to define pragmatic approaches for specific initiatives in a thorough and concise manner. Applies modern project management techniques, achieving scope, quality, time, and cost objectives.

PROGRAM MANAGEMENT: Served as a liaison, coordinating infectious disease research efforts and applying fact-finding techniques to support program development and execution. Served the laboratories of Dr. Deb Fuller, Dr. Nikki Klatt, Dr. Michael Gale, and Shiu-Lok Hu by managing their research projects. Cross-divisional Research Liaison between Core Scientists/external PIs and DPR/veterinary staff. This also includes collaborations with research teams or divisions from other primate centers (i.e., WNPRC, TNPRC), development of experimental plans, facilitating communications and specimen collection coordination between DPR and research staff across multiple divisions and other institutes, coordinating schedules with RSG and external researchers and coordinating the transfer of specimens to internal and external labs.

NON-HUMAN PRIMATE RESEARCH COORDINATOR: Communication and coordination of non-human primate studies between the labs, external collaborators, and the Department of Primate Resources. Provided grant support by developing animal study deliverables and timelines. Maintain Regulatory management, site visits (IACUC, BUA, EH&S, MyCHEM, Animal Research Management System (ARMS), site visits, Host Site Reviews, etc.

LABORATORY MANAGEMENT: Coordinate use of shared equipment, facilities, employees, projects of the retroviral lab, mucosal immunology core, flow-cytometry core (LSRII, FACs Aria (cell sorter, Biosafety Laboratories 2+, 3), Animal and sample management

FINANCIAL MANAGEMENT: Core and Program Income (Equipment maintenance, training, user logs, personnel effort, budget, and billing). Budget, Billing, and Services management of NHP Core services for investigators. Development of price lists, database, and repository requests for specimens and invoicing

RESEARCH SCIENTIST IV: Coordinate non-human primate studies (AIDS/(s)HIV/Influenza/etc.) across research centers and multi-departments. Collaborate with P.II's lab managers and key personnel. Develop, manage, and update schedules of studies and research. Coordinate samples across studies and multiple facilities. Research, analyze, and collect data (Bioinformatics, In-vitro, in-vivo, clinical and pre-clinical research)

KEY ACHIEVEMENTS:

1.Invited by Leadership to participate in the creation of UW's Certificate in Research Administration at the University of Washington. This allows research professionals to understand research administration practices, policies, and resources at the UW. This certificate program will support campus departments as a central unit to align practices, share expertise across units, and support UW learners in forging career pathways for themselves.

2.Lab start-up for Deb Fuller's Laboratory, the Mucosal immunology Core and Flow-Cytometry Core

OTHER QUALIFICATIONS

COMPUTER & EQUIPMENT SKILLS: Software and Servers like SharePoint, Dropbox, Smartsheet.gov, Microsoft Project, MS Project, MS Office, Office 365, PowerPoint, Acrobat, NIAID internal systems, eRA, USA.gov, deltek search engines, PubMed, GenBank, EPIC, Smartsheet, RedCap, Qualtrics, ABI 377, 3100, 3700, MAS 5.0, Sequencher Software, Automated DNA sequencers, Automated Pipetting Systems, LIMS, PCR, and Affymetrix fluidics and scanner machines, Image J, Imaris Bitplane, LSR2 Flowcytometry (18 color), FACs Aria, clinical diagnostics (Yerkes, VRL, Marshfield, IDEXX, UGA Lab), electronic medical records (EMR), Confocal, Zeiss, Marianas, Widefield imaging, Live cell Imaging, GFP tracking, fluorescence, photoactivation, Imaris Bitplane, Image J, EProcrument (UW Purchasing System), purchase path (WaNPRC ordering system), myfinancial desktop (UW budgeting system), MyChem, ARMS (WaNPRC animal records database), FACS DIVA, (LSR2 software), FlowJo & prism. Website design input. Databasing samples, reagents and storage logs.

JOB-RELATED TRAINING: Research Administration, RedCap, EPIC comprehensive training, Professional Billing for EPIC, Creating and Submitting Contracts and Grants, Direct billing of F&A type costs, NIH Implicit Bias, NIH information Management, NIH Security of Management, NIH Office of Extramural Research: Protecting Human Research Participants. Collaborative for Research Education training (CORE), Controlled Substance / Select Agent

LICENSES & CERTIFICATIONS: State of Washington: Patient Care Technician, Certified Nursing Assistant, Chemical Safety Officer / Physis Global Academy: Clinical Research Coordinator (CRC), Clinical trial project management (CTPM) / CITI Certificates: Clinical Research Coordinator, Clinical trial project manager, biomedical responsible conduct of research course, conflict of interest, export compliance, GCP for clinical trials with investigational drugs and medical devices (US FDA Focus), Humanities responsible conduct of research course, Understanding consent requirements and key information under the revised rule, Biomedical research, Social and Behavioral Research Best Practices for Clinical Research, GCP social and behavioral research best practices for clinical research, Good clinical practice and ICH (GCP), Citi health information privacy and security (HIPS) for clinical investigators, Human Subjects Learners / Project Management Institute: Project Management Professional, Project Management Foundations: Schedules, Project Management Foundations: Budget, Project Management Foundations: Communication, Financial Conflict of Interest, Project Management Foundations: Government Contract and Finance, Project Management: International Projects, Project Management: Tips, Leadership Foundations / Public Contracting Institute: Introduction to Government Contracting Fundamentals, Government Financial Contract Training, Financial Conflict of Interest / BD Training: BD LSRII Operator course, BD FACS Aria II Operator Course

AWARDS & RECOGNITION

My most outstanding achievement is the personal letter I received from Dr. Anthony Fauci during the pandemic, appreciating my dogged determination and tireless contribution to NIAID and the SAVE Program’s critical role in vaccine formulation during the COVID-19 pandemic.

Organizing a large meeting for the CEIRR Annual Network Meeting 2022, in a pandemic, in another state, was recognized as a feat: CEIRR Annual Network Meeting 2022 (ceirr-network.org).

DEBBIE BRATT’S BIBLIOGRAPHY

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