Senior Scientist, I - S&T - Downstream

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The 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 characterization, 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 products.
• 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 recommendat