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

• Lead and mentor a team of 10-12 scientists specializing in establishing separation-based assays including HPLC (e.g. SEC, IEX, RPLC), capillary electrophoresis (CE, icIEF), etc. for QC lab implementation to support GMP release and stability testing and for sample testing in PDS&T - Analytical Development to support biologics DS process development, characterization, validation as well as GMP manufacturing investigation activities.  Develop high-throughput analytical methods and drive timely delivery of high-quality testing results.
• Serve as a primary contact for Analytical Development in AbbVie's CMC teams, supporting both early and late-stage biologics pipeline assets.  Balance stakeholder expectations between PDST and other AbbVie analytical functions to ensure effective collaboration.
• Develop, communicate, and implement analytical strategies with broader PDS&T analytical functions and CMC business partners.  Oversee experimental execution, development, qualification, validation, and transfer of robust analytical methods for QC lab as well as analytical control strategy development.
• Guide team to evaluate and select effective analytical technologies and methods for meeting program needs.  Evaluate and interpret data trends in release and stability assays.  Demonstrate scientific excellence in the analytical characterization of biologics and ensure robust documentation of study findings.
• Author and review analytical sections of IND/BLA filings for early and late-stage programs, provide response support to agency information request.  Ensure all submissions comply with regulatory requirements and industry standard.
• Collaborate with other analytical teams in R&D and PDS&T