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Case Studies

Project Team: Manufacturing Strategy and Management Process Improvement

Project Challenge

Advisors Profile

Biomanufacturing and biologics process developmentFormerly with Immunex and Coulter Pharmaceuticals, led the Process Development and Materials Management departments of all products from pre-clinical development through commercialization.
CMC/Drug SubstanceFormer Senior Director of Process Chemistry. Designed processes for supply chain management and sourcing/vendor management.
Drug ProductFormer Director of Pharmaceutics R&D with over 20 years experience in preformulation studies and drug product development.
Manufacturing StrategyFormer head of Manufacturing Strategy, with expertise in multi-site manufacturing operations, quality systems, and scale-up issues.
Operational ManagementEngineer with over 20 years experience in planning, design and operation of both organic chemistry and biologics facilities from laboratory- to full manufacturing scale.
Regulatory Perspective on Contracts and OperationsFormer Director of International Quality Assurance with world-wide internal auditing responsibility for bio-manufacturing facilities for a major European pharmaceutical company