Senior Scientist, I

Job Description
The PDS&
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 toxin products at AbbVie. We have an exciting opportunity for a Senior Separations Scientist position based in Irvine, CA.
Lead the development, qualification, validation and troubleshooting of separation methods for biologics including HPLC, capillary electrophoresis and SDS-PAGE.
Provide analytical support for process characterization and manufacturing of late-stage and commercial biological programs.
Identify and drive continuous improvement initiatives and implement new technologies to contribute to future business developments and improvements.
Author CMC analytical sections of BLA and other CMC regulatory packages, including analytical methods, specifications, analytical comparability, and stability assessment. Support agency inspections and inquiries.
Present analytical development topics in cross-functional CMC meetings.
Partner with diverse groups within the function and maintain strong working relationships with internal, global, and external collaborators.
Perform routine testing of in-process samples using various separation techniques.
Troubleshoot any issues that arise during routine testing and provide solutions to ensure accurate and reliable results.
Perform method validations in a GMP laboratory setting to ensure compliance with regulatory requirements. Author protocols, reports, and SOPs for development and GMP laboratories.