Senior Scientist, Ii - Analytical Method Development

Job Description
The Toxins Analytical group within AbbVie Operations Product Development Science &
Technology - 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 Senior Scientist II position based in Irvine, CA. The scientist will apply molecular biology principles, particularly, construction of plasmid- and virus-derived vectors to deliver and stably express reporter genes in mammalian cells and clonal screening to develop, validate and implement robust toxin potency testing methods. The candidate must have demonstrated in-depth knowledge and experience including but not limited to reporter gene-based cell-based assays, e.G., mechanisms of how transgene products work, cellular cloning, method development, qualification, validation and cross-validation with orthogonal version of methods where it applies. Excellent verbal/written 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 validation, investigations, troubleshooting, scale-up, and continuous improvement.
Design and evaluate feasibility of utilizing diverse vector systems to deliver reporter genes into clinically relevant cell lines for stable expression.
Cellular cloning of transgene expressing cells based on desired stability and sensitivity to drug candidates through cell-based assays.
Identify and implement technical innovations to improve analytical testing for better product quality, qualify and manage new external CROs, and enhance the intellectual property landscape.
Support CMC life cycle management and post-approval continued process validation for commercial DS.
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 recommendations as to the acceptability and quality of affected product lots.
Author and review relevant CMC sections of submissions and support agency inspections, inquiries and audits.
Represent the S&
T Toxins group in CMC program teams. Interacts effectively with diverse groups within function and maintains strong working relationships with internal, global, and external collaborators.
Responsible for compliance with applicable Corporate and Divisional policies and procedures.