Principal Consultant and Vice President of Biologics CMC
Spectrum Pharmaceuticals, Inc. An International Commercial-Stage Biotechnology Company
Biologics operations professional with demonstrated track record of excellence in strategy and execution in biologics manufacturing and quality assurance; proven in improving safety and quality, optimizing production, and reducing cost. High-energy, collaborative leadership style that inspires results. Skills and experience: • profit-and-loss • biologics manufacturing and quality control/testing - clinical through commercial • operational excellence, including business process improvement • operations - supply chain, risk management • quality assurance (CGMP) and regulatory submissions • regulatory compliance, remediation, consent decrees, regulatory inspections • financial analysis and controllership • sales and marketing • leadership, staff development, team-building • strategy development and execution Prior work experience at: • Amgen (14 years) • Genzyme • Charles River Laboratories • UMass Medical Center Alumna of: • Stanford University (MBA) • Brown University (BA)
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