VIROMED미국 현지 법인 COO : Keith Hall
대학교에서 MICROBIOLOGY 전공 MBA 전공...
VICAL에서 15년 이상 근무...
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Executive with over 25 years of biopharmaceutical experience in Manufacturing, Quality, Process and Assay Development. Manage multi-departmental budgets and resources with a proven record of meeting project milestones, achieving corporate objectives, and managing costs within budget. Direct and manage operational activities related to drug substance and drug product production, in addition to CMC support for development and regulatory activities required for licensure of vaccine for the prevention of CMV reactivation in hematopoietic cell transplantation and solid organ transplants, and HSV-2 vaccine program.
경력 사항
Provide strategic leadership and operational oversight to the Manufacturing, Engineering, Validation, Quality Control and Assay Development groups.
Executive Team member responsible for corporate leadership, direction and strategic planning.• Responsible for leadership and oversight of Quality Control and Assay Development activities and budgets. Establish departmental goals, objectives, and operational metrics. Align objectives and functional area deliverables with corporate goals.
• Sr. Mgmt. representative on business development/partnership team. Provided Manufacturing and Quality leadership during partnership due diligence meetings. Provided technical overviews, address questions, and provided project related cost forecasts.
• Participate on cross-functional teams responsible for planning and process improvement activities (i.e., change control, quality, and manufacturing review boards).
• Design and implement quality systems, policies and practices compliant with all applicable laws and regulatory requirements (US, EU, Japan & ROW)
• Mentor and develop staff by providing and maintaining a collaborative work environment that is open and inclusive. Manage resources in accordance with company policies and procedures.
• Provide analytical and CMC regulatory support for client specific drug substance and drug product manufacturing projects.• Developed budget, project timelines and managed construction and start-up of Agennix’s recombinant human lactoferrin phase III/commercial manufacturing facility located in Capua Italy. Project completed on-time and $1 million under budget.
• Managed international project team responsible for process development, technology transfer to Capua facility, and manufacture of Recombinant Human Lactoferrin (rhLF) drug substance (DS).
• Evaluated, selected, and negotiated Fill/Finish CMO (Baxter, Patheon, Formatech), CTO (e.g., Lancaster, Nelson) and Materials Management (McKesson, Almac) contracts; managed contract activities
• Responsible for the CMC section of Agennix’s regulatory filings (e.g., FDA, EU/EMA, PMDA)
• Negotiated rhLF DS supply contracts and managed international corporate partnerships (Santen Pharmaceuticals, Meiji Pharma)
