Principal Research Scientist II

AbbVie Operations Parenteral Product Development Science & Technology (PDS&T) Department is a global organization responsible for all CMC activities related to the development and commercialization of AbbVie's parenteral products.  Our scope includes AbbVie's diverse pipeline of innovative therapeutic biologics medicines, including monoclonal antibodies, antibody drug conjugates (ADC), and other novel modalities, and spans from clinical proof of concept through commercial product launch.  We are a world-class team of scientists and leaders driving the advancement of industry-leading analytical capabilities and AbbVie's pipeline of innovative medicines.  Careers in AbbVie Parenteral PDS&T provide opportunities to work with global and cross-functional teams to develop innovative products and drive exceptional science. The Biologics Analytical group in Parenteral PDS&T is responsible for programs that are transitioning from development stage to optimization and commercialization.  We lead final method development, optimization, and validation, ensuring all analytical methods are fit for use in commercial QC laboratories.  Key deliverables include product control strategies informed by analytical data and method understanding; robust analytical methods suitable for commercial QC labs; comprehensive data packages that drive product and process understanding; stability studies to establish commercial product dating; and approvable marketing application submission content.  We are looking for a highly motivated person who can oversee laboratory activities within the Biologics Analytical group in Parenteral PDS&T. Key Responsibilities • Provide leadership and talent development for a team of scientists responsible for a suite of late-stage biologics products including monoclonal antibodies, antibody drug conjugates, bispecific antibodies, etc. • Lead activities associated with analytical characterization of late-stage biologics compounds including assessment of process/formulation development samples, feasibility studies, clinical and commercial in-use, etc. • Demonstrate a critical mindset for method troubleshooting, examining data wholistically, and guiding and advising scientists through study execution. • Responsible for management of lab activities including established lab standards and best practices, documentation and verification. • Independently responsible for project activities within area of expertise while also contributing within the project team to the overall progress of the program. • Deliver results in a team-oriented setting and willing to work across scientific disciplines to drive programs through critical milestones. • Effectively organize and present scientific plans and data. • Author technical documents (e.g., methods, protocols, reports, etc.), scientific publications, presentations, and regulatory documents. • PhD (8+ years), Master’s Degree (14+ years), or Bachelor’s Degree (16+ years) in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) with previous laboratory experience.  Previous supervisory experience managing teams required. • Practical experience with method validation and working in a GMP environment is required including designing studies, authoring protocols and reports, laboratory notebook documentation, etc. • Experience with investigations, validation events, out of specification, or out of trend evaluations preferred. • Familiarity with analytical Quality by Design (AQbD) preferred. • Practical experience and strong knowledge of protein HPLC (e.g., SEC, IEX, HIC), capillary electrophoresis, and other separation techniques as applied to protein analysis is preferred. • Solid understanding of protein chemistry and biochemistry, particularly as related to bio