Senior Scientist, I - Msat

Job Description
The S&
T Toxins group within Operations Science &
Technology - Biologics organization supports manufacturing, 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 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 S&
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.