Principal Research Scientist Ii, Biologics Ard

Job Description
AbbVie Biologics Analytical Research &
Development (Biologics ARD) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's therapeutic biologic 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 the selection of Discovery candidate molecules through the transition of analytical methods and testing to commercial labs to support product launch. We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines. Careers in AbbVie Biologics ARD provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies.
We are looking for a highly motivated person who can drive the early phase analytical development and oversee laboratory activities of new biologics transitioning from Discovery through clinical proof of concept. The candidate will lead a group of motivated scientists in method development, method validation, release and stability testing of new biologic development compounds and provide key data for regulatory submissions. The candidate will serve as the analytical representative on the CMC team for early development programs and as such would be responsible for developing timelines and executing analytical activities required for drug substance and drug product development. The candidate must be able to mentor and develop staff with novel experimental approaches to answer difficult scientific questions. Working closely with formulation and process development scientists, the candidate will develop productive collaborations and communications with scientific teams.
Responsibilities:

Lead activities associated with analytical characterization for new biologic compounds, including assessment of process/formulation development samples and clinical trial supplies, (e.G. GMP compliant release and stability testing).
Lead the design and execution of experiments for method validation studies.
Lead analytical strategy development for FIH programs.
Proactively advise and share knowledge and expert opinions with subordinates, peers, and senior management. Mentor staff in troubleshooting equipment and experimental problems.
Author and review key regulatory documents, laboratory data, technical memos and reports.
Encourage ideas for continuous improvement activities and initiatives within work group.
Understand and adhere to corporate standards regarding code of conduct, safety and GXP compliance.