The Product Development, Science and Technology (PDS&T), Toxins group supports manufacturing, process characterization, process validation, regulatory submission, and continuous improvement for late-stage and commercial manufacturing of biological toxin products in AbbVie. We have an exciting opportunity for a Senior Scientist I, Upstream Toxin Process position based in Irvine, CA. The scientist will apply scientific, engineering principles, modeling and statistical process design/analysis to develop robust toxin manufacturing process hands-on. The candidate must have in-depth knowledge and hands-on experience including but not limited to bioprocess development, scale down model qualification, protein characterization, etc. Excellent communication skills and the ability to work within a multi-disciplinary and cross-functional teamwork environment are essential. 

Responsibilities

• Support late stage and commercial biologics manufacturing, technology transfer, process validation, investigations, troubleshooting, scale-up, and continuous improvement.
• Develop and optimize upstream process conditions, including cell bank generation, fermentation culture and harvest strategies, to improve productivity, product quality, and process robustness.
• Design, execute and analyze experiments using a robust scale-down model for upstream process characterization and continuous improvement of commercial biologics products.
• Provide microbiology support for new product introduction, including contamination risk assessment, environmental monitoring strategy support, and coordination of microbiological activities as needed for manufacturing readiness.
• Evaluate system biology tool to enhance understanding on cellular metabolism.
• Leverage data science and advanced modeling to build digital platforms for data visualization and analysis.
• Author and review relevant CMC sections of submissions and support agency inspections, inquiries and audits.
• Represent the PDS&T Toxins group in CMC program teams. Interact effectively with diverse groups within function and maintain strong working relationships with internal, global, and external collaborators.