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 II, Downstream Purification 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 protein recovery and purification process that utilizes clarification, chromatography, and membrane filtration technologies. Provide deeper understanding of process performance using appropriate experimental and modeling tools.
• Design, execute and analyze experiments using a robust scale-down model for process characterization and continued process improvement of commercial biologics products.
• Leverage data science and advanced mechanistic modeling to build digital platforms for data visualization, analysis and prediction.
• Support/ lead new product introduction into the manufacturing area, ensuring successful tech transfer, scale up and validation for the product.
• Support product investigations and non-conformances. Identify root causes and make scientific recommendations as to the acceptability and quality of affected product lots.
• 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.