Senior Scientist II - Biologics Drug Product Development

Role Summary

Senior Scientist II - Biologics Drug Product Development at AbbVie. Responsible for lead developability assessment activities, leveraging mass spectrometry and advanced characterization to influence design and development of stable drug product formulations and manufacturing processes for biologics in clinical trials. Collaborates with global teams across Discovery, Analytical, Process R&D, and Product Development Science & Technology to drive innovative approaches and improve workflows.

Responsibilities

• Lead developability assessment activities, including candidate screening and selection for clinical studies of monoclonal antibodies, antibody drug conjugates, bispecifics, and fusion proteins.
• Utilize analytical instruments to understand structural stability of biotherapeutic entities to influence candidate protein sequence design and selection.
• Develop independent research ideas and pursue scientific questions to continually improve developability approaches. Present data at internal and external professional conferences and prepare manuscripts for publication in peer reviewed journals or patent applications.
• Build and manage strategic alignments with key stakeholders, revise and improve business workflows, manage project timelines and resources. Develops the optimal CMC development path for assigned discovery projects together with clients from various R&D functions with an emphasis on collaboration, quality and with a sense of urgency.

Qualifications

• Bachelor‚Äôs Degree or equivalent education and typically 12 years of experience OR Master‚Äôs Degree or equivalent education and typically 10 years of experience OR PhD and typically 4 years of experience.
• At least 2 years of industry experience in CMC Development of biotherapeutics are preferred
• Deep understanding of protein stability characterization (e.g., SEC, IEX, HIC, CE)
• Additional robotics expertise and digital data capture experience is beneficial
• Knowledge of functional excipient degradation pathways is a plus
• Solid understanding of the scientific approaches to develop commercially viable protein drug products

Key Competencies

• Builds strong relationships with peers and cross functionally with partners outside of the team to enable higher performance.
• Excellent oral communication skills in a scientific setting as well as sound technical writing and documentation competencies are required.
• The candidate must be able to work independently, respond to changing priorities and short lead times for multiple tasks; able to identify problems and work toward solutions.
• Raises the bar and is never satisfied with the status quo.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.