Principal Research Scientist II

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 PDS&T group within Product Development, Science & Technology - Biologics organization supports manufacturing, process transfer/optimization/characterization/validation, analytical method transfer/optimization/validation, product characterization, regulatory submission, and continuous improvement for late-stage and commercial biological toxin products at AbbVie. We have an exciting opportunity for an innovative and motivated individual to join us as a Group Leader based in Irvine, CA reporting to the Director, PDS&T.     

Responsibilities

• Manage the protein characterization group by working with a group of senior and principal scientists to ensure efficient day-to-day group operation; high-quality data generation and interpretation to drive the growing product and process understanding required as part of neurotoxin development.
• Drive group performance by setting clear objectives, monitoring progress, and ensuring the consistent achievement of team goals, while actively creating development opportunities to motivate and support a high-performing team.
• Lead CQA assessment and relevant characterization studies (e.g., forced degradation study, and protein structure elucidation) for a comprehensive understanding of the product structure-function relationship.
• Lead CMC analytical development with in-depth knowledge of a broad range of analytical techniques for biologic products.
• Author and review CMC analytical sections of BLA and other CMC regulatory packages. Develop strategies for addressing health authority inquiries.
• Provide technical leadership for agency inspections, inquiries, and audits.
• Contribute to the operation strategy development