Support existing manufacturing processes and technology transfer to new US based manufacturing site. Position will focus on supporting purification operations in the production of the flu cell culture vaccine.
• Manufacturing support activities including process mapping, process troubleshooting, process improvement, process management and supporting DOE experiments based on Six-Sigma methodologies
• Person-in-plant during start-up full-scale development, validation runs, and ongoing commercial manufacturing runs
• Support preparation of for process scale-up, process transfer and process validation
• Participate in technical risk assessment for process issues and changes
• Assist in technical studies for at-scale and scale-down studies to support new strain introduction and process improvements
• Bachelor's Degree in Engineering, Biological Sciences or related field. Advanced degree such as M.S. or specialization/training in biotechnology preferred.
• 6+ years of successful experience in process development or manufacturing support of biotechnology derived vaccines or biopharmaceuticals is required
• In-depth knowledge and work experience in purification is required
• Experience in technology transfer, scale-up, and new GMP facility design project support is required
• Demonstrated laboratory skills including associated analytical methods is desirable
• Must be able to effectively partner with diverse team members from various functions and at various levels in organization.
Novartis - 20 months ago
Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...