USG lead for scientists in CMC, Non-clinical, Clinical, and Assays-In vitro diagnostics for the development of medical countermeasures for chemical, biological, radiological and nuclear defense

-Co-developed the 3PI program at MCS-JVAP (Proven, Platform, Performer)-Develops and manage substantial and ongoing biological research programs in the development and testing of vaccines. Work with client organizations to design highly complex research programs and studies and develops solutions to complex problems-Plan and lead highly complex and advanced technical projects where technical staff compile and evaluate design and test data, prepare technical specifications, analyze technical data to determine appropriate limits and variables for product, process or materials specifications-Prepare, review and/or approve highly complex reports and presentations. Provide innovative solutions and recommendations.-Review projects progress and evaluate results. Recommend modifications and corrections in technical applications and analysis. -Develop project and overhead budgets with clients and management. Develop innovative testing and/or analysis methods to solve highly complex problems-Build relationships with internal and external clients. Consult with senior managers in client organizations on long-term research agendas and definition ofresearch programs. Manage client meetings. Present results to clients, regulators, stakeholders, and in public forums as necessary.

• Vaccine development, production, and stockpile to protect the warfighter against biological agents• Recombinant and viral antigen expression and recovery process development and manufacturing • Manufacturing Lead for integrated project teams (Filo, Bot, Plague, Small Pox, Anthrax, Ricin)• CMC review for FDA submissions, white papers, RFI, RFP, and contracts/awards• CMO process development, technology transfer, scale-up/down and manufacturing oversight• Coordinate manufacturing activities with integrated product teams • Facility audits for technical execution, cGMP, and DoD requirements for Phase I through Commercial• Review and approve CMO QbD approach to product development • Process validation oversight (definition, validation, and monitoring)• Advise and review investigations related to manufacturing and quality investigations• Review development and manufacturing data to ensure processes are operating in a state of control

• Scale-up and Technology Transfer - BioThrax®, Anthrax Vaccine Adsorbed, 100L to 1320L• Commercial Product Experience - BioThrax®, Anthrax Vaccine Adsorbed• CMC Leader Process Validation Life Cycle Development – BioThrax Process Improvement Plan • Product Development – 2nd and 3rd Generation Anthrax Vaccines and Anthrax Therapeutic Antibodies • Oversight 65 individuals with 1-3 directors and 4-6 managers, annual operations budget of $7-8 MM• Multiple upstream, downstream process and analytical development laboratories• Manufacturing sciences and technology and support for commercial manufacturing• QbD program development and champion for the site, Thomas Little and Associates• Upstream production support, process development, cell banking, media formulation, and fermentation• Downstream production support, process development, centrifugation, UF/DF, TFF and chromatography• Initiated BioThrax Improvement Plans and gained FDA buy-in for post marketing development • Technology transfer, rPA, rLF, BioThrax, NuThrax and vaccine filling (Upstream and Downstream)• Problem solving for manufacturing and quality investigations• Development and manufacturing representative for FDA and EU site inspections• USG Grant writing, CMC development/manufacturing sections for multiple development proposals, procurement proposals and white papers• Manufacturing Lead for 3rd Generation Anthrax Vaccine, AV7909• Key person for Process and Analytical Development on BARDA grant to develop a Large-Scale Manufacturing Process for BioThrax®, Anthrax Vaccine Adsorbed ($107 MM)• Leadership development of management team, interdepartmental team building (KTS, Strengthfinders 2.0,Thomas Killman)• Co-chair for the local governance committee, oversight of $15-22 MM annual capital budget • Support mergers and acquisitions; manufacturing and development due diligence

• Process Development Group: Leading Lansing site technology transfer, process development, scale-up, process characterization, and process qualification. • Managed team of scientists and engineers (6 staff). • Communicating vision and objectives to department heads and works closely with Lansing Governance and Steering Committees.• Managed Clinical Manufacturing Group (9 staff): 2,500 sqft pilot plant facility. Coordinate 2-3 development projects per year in support of the Emergent product portfolio. Projects involved in to date include AVA scale-up, anthrax toxin expression and purification, botulinum vaccine manufacturing assessment, and several Next Generation Anthrax Vaccines. • Established internal work group to develop methods for supporting process development work. Technology transfer of methods to and from outside development groups and quality control for validation. • Expanded group to include analytical development (8 staff), technology transfer of assays from development groups into our labs for validation. • Secured funding for laboratory renovation, including equipment and stability storage space

Role of fibulin proteins in Bruch's membrane and implication for Age-related macular degeneration.