Summary:Experience in the Biotech industry for over 20 years, proficiencies include both mammalian and microbial technologies. Coordinated commercial and clinical operations at both internal and external manufacturing facilities. Leader in site start up including technology transfer, validation and regulatory submissions. Oversight of both Drug Substance and Drug Product operations. Manage a multi-discipline organization including technology, operations and supply chain. Commercial production revenues exceeding $2.5B.Specialties: • Planning and Scheduling• Budget Coordination• Disposable Technologies• cGMP• Bacterial Fermentation• PAI Preparation & Remediation Planning• Mammalian Cell Culture• Project Management• Cell Separation and Purification• Multi-Product Facilities• Lyophilization• Technology Transfer and Process Validation Coordination and Oversight• Pre-Filled Syringe Technology• Contractor Selection• Evaluation and Qualification• Media hold studies• Contract Negotiations• Operational Excellence