Principal Research Scientist II

About the role

The Cell Culture Development organization within Operations leads process development and tech transfer for cell culture processes supporting clinical manufacturing and commercialization of therapeutic proteins across AbbVie’s pipeline. The role is responsible for managing a team of scientists and engineers to solve complex challenges across AbbVie’s diverse biologics pipeline.

Responsibilities

• Manage a group of 2+ scientists and engineers (BS/MS and PhDs) focused on systems biology applied to bioprocess improvement, including cell culture media development and process optimization.
• Lead cell culture process development for monoclonal antibodies, bi-specifics, ADCs, fusion proteins and other molecular formats for early- and late-stage clinical assets.
• Lead PPQ enabling cell culture process characterization activities.
• Participate in cross-functional CMC teams and review relevant sections of regulatory submissions (e.g. IND, BLA, MAA, etc…).
• Mentor and develop staff to foster a high-performance culture that achieves business and scientific objectives.
• Build strong relationships with other process and analytical development, Manufacturing Sciences and Technology, R&D, Manufacturing, Quality and Regulatory teams to improve efficiency, productivity, robustness and product quality.
• Advance technical expertise within the cell culture development field by tracking emerging trends and technologies within the field through internal and external sources, and proactively sharing knowledge with the team, peers and management.
• Represent the organization as a scientific thought leader through conference presentations, publications, and broader engagement in the external and internal scientific community.

Qualifications

• Advanced degree in Biology, Biochemistry, Chemical Engineering, Data Science, or a related discipline, with 16+ years of experience for BS holders, 14+ years for MS holders, or 8+ years for PhD holders; highly qualified candidates with fewer years of experience may also be considered.
• Demonstrated executive presence with exceptional interpersonal and communication skills, strong scientific curiosity, and a proven ability to solve complex problems and drive optimization.
• Self-directed and highly organized, with strong attention to detail, outstanding planning and troubleshooting capabilities, and the ability to manage multiple priorities effectively.
• Deep understanding of cell culture processes, including cell and molecular biology, process development, scale-up and scale-down, recombinant protein production, and protein characterization.

Preferred Qualifications

• Demonstrated proficiency in bench scale bioreactor and other high-throughput cell culture systems for the optimization of cell culture processes.
• Experience with or ability to lead a team with focus on cell culture media development, including the application of complex statistics and systems biology.