Pharma Principal Scientist

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

Purpose:

The Product Development Science & Technology (PDS&T) Toxins group within AbbVie Operations - 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 Principal Research Scientist I position based in Irvine, CA.

The Pharma Principal Scientist will support extended physicochemical characterization of late-stage and commercial neurotoxin programs for regulatory filings including new BLA submissions and life-cycle management of approved products. The candidate must have demonstrated in-depth knowledge and experience in structural characterization including but not limited to physicochemical, separation, and mass-spectrometry techniques to support late-stage and commercial pipeline assets.

Responsibilities:

• Manage the efficient and comprehensive transfer of prior knowledge from senior members of the team, various AbbVie sites, and contract development and manufacturing organizations. Centralize the knowledge within a digital system to ensure it is accessible, well-organized, and ready for effective future use.
• Design and execute extended physicochemical characterization, forced degradation, critical quality attributes (CQA) determination, structure-function relationships, elucidation of structure (EOS), reference standard qualification, and comparability of drug substance for late-stage biologics and neurotoxin pipeline programs. Interpret data from different characterization experiments to identify key structural attributes.
• Provide analytical support for proces