Principal Research Scientist II

AbbVie • North Chicago, IL

8h

About The Position

AbbVie Operations Parenteral Product Development Science & Technology (PDS&T) is a global organization responsible for CMC activities related to developing and commercializing AbbVie's parenteral products. Its work spans a diverse pipeline of therapeutic biologics, including monoclonal antibodies, antibody drug conjugates, and other novel modalities, from clinical proof of concept through commercial product launch.

The Biologics Analytical group supports programs transitioning from development to optimization and commercialization. The group leads final method development, optimization, and validation to ensure analytical methods are suitable for commercial QC laboratories. Key deliverables include analytical-data-informed product control strategies, robust methods for commercial QC, data packages that support product and process understanding, stability studies to establish commercial product dating, and content for marketing application submissions.

The Principal Research Scientist II will oversee laboratory activities in the Biologics Analytical group and provide leadership and talent development for scientists working on late-stage biologics products. The role leads analytical characterization activities, guides scientists through study execution and troubleshooting, manages laboratory practices and documentation, contributes to project progress, and authors technical and regulatory materials.

Requirements

• PhD with 8 or more years of experience, master's degree with 14 or more years of experience, or bachelor's degree with 16 or more years of experience in a scientific discipline such as Analytical Chemistry, Biochemistry, or Biology.
• Previous laboratory experience.
• Previous supervisory experience managing teams.
• Practical experience with method validation and working in a GMP environment, including designing studies, authoring protocols and reports, and maintaining laboratory notebook documentation.
• Ability to multitask and work within timelines.
• Demonstrated scientific writing skills and strong verbal communication skills.

Nice To Haves

• Experience with investigations, validation events, out-of-specification, or out-of-trend evaluations.
• Familiarity with analytical Quality by Design (AQbD).
• Practical experience and strong knowledge of protein HPLC, such as SEC, IEX, and HIC; capillary electrophoresis; and other separation techniques applied to protein analysis.
• Solid understanding of protein chemistry and biochemistry, particularly in biologics drug development.

Responsibilities

• Provide leadership and talent development for a team of scientists responsible for late-stage biologics products, including monoclonal antibodies, antibody drug conjugates, and bispecific antibodies.
• Lead analytical characterization of late-stage biologics compounds, including assessment of process and formulation development samples, feasibility studies, and clinical and commercial in-use studies.
• Troubleshoot analytical methods, examine data holistically, and guide and advise scientists through study execution.
• Manage laboratory activities, including established laboratory standards and best practices, documentation, and verification.
• Independently manage project activities within the area of expertise and contribute to overall project progress as part of the project team.
• Work across scientific disciplines in a team-oriented setting to advance programs through critical milestones.
• Organize and present scientific plans and data effectively.
• Author technical documents such as methods, protocols, and reports, as well as scientific publications, presentations, and regulatory documents.

Benefits

• Paid time off, including vacation, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) for eligible employees.
• Eligibility to participate in long-term incentive programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal