Purpose:

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 toxins products in AbbVie. We have an exciting opportunity for a Senior Scientist position based in Irvine, CA. The scientist will apply scientific, engineering principles and statistical process design/analysis to develop robust toxin manufacturing process hands-on. The candidate must have in-depth knowledge and 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.
• Design, execute and analyze experiments using a robust scale-down model for process characterization and continued process improvement of commercial biologics products.
• Identify and implement technical innovations to improve product quality, improve yield, qualify new material suppliers, reduce cost and/or enhance the intellectual property landscape.
• Support CMC life cycle management and post-approval continued process validation for commercial DS.
• 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. Interacts effectively with diverse groups within function and maintains strong working relationships with internal, global, and external collaborators.
• Responsible for compliance with applicable Corporate and Divisional policies and procedures