A highly experienced Executive who has demonstrated the ability to lead diverse technical teams in fast-paced environment to achieve new levels of success. Strong technical and business qualifications with an impressive track record of more than 27 years of hands-on experience in the areas of: • Small Molecule, Large Molecule, Cell Therapy, mAB, Fill Finish experience • Strategy Development & Implementation • Multi-Site Operations Commercial and Clinical • Quality Systems Development & Management • Talent Review and management • FDA, Audit Remediation & Turnaround • Program / Project Development & Implementation • Managing Change Imperatives • Business and Customer Supports • Risk Based Validation • Technical Transfer and Scale-up • Facility Capital Project • Master’s In Mfg Engineering, Northwestern University
Example Accomplishments: * Leadership Focus is on Strategy, Processes, Development, Improvement, and Budgets. * Prioritized staff development resulting in enhancing 85% of staff’s skill enabling an Staff Engagement score Improvements of >20% in 2 years along with supporting a 40% increase in production without adding headcount. (Genentech) * Championed improvements for Multiple Quality System (QS) to meet FDA cGMP requirement resolving over 10 FDA 483 citation in less than 10 months. No repeat QS Citation on subsequent inspection. (Avrio Biopharma/ currently Nitto) * Implemented a Phase appropriate GMP approach to ensure compliance and meet business goals. (Avrio / Sorrento) * Supported multiple commercialization of biological and small molecule drugs at various organization (Medimmune, Genentech, Amylin, Others)
Specialties: Quality | Operation | Program Mgmt | Project Mgmt | Validation | Facility | Risk Mgmt | Cont. Improvement | Strategic | Leadership| Small Molecule, Large Molecule, Cell Therapy, mAB, Fill Finish experience
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