Principal Research Scientist or Senior Scientist II, Biologics Analytical Research and Develo

Overview

Abb Vie Biologics Analytical Research & Development (Biologics Analytical R&D) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of Abb Vie s pharmaceutical products. Our scope includes Abb Vie s diverse pipeline of innovative therapeutic biologic medicines 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 Abb Vie s pipeline of innovative medicines. Careers in Abb Vie Biologics Analytical R&D provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies.

The biologics characterization group develops state-of-the-art analytical techniques for in-depth characterization of therapeutic proteins and other novel biologic molecules using advanced, combined analytical techniques. We are looking for diverse candidates with strong scientific and leadership experience to join the Abb Vie Analytical R&D team and can offer exciting and rewarding career opportunities for these candidates.

• Serve as a subject matter expert in BioARD, lead phase-appropriate analytical development strategies for biologics characterization including ADC, multi-specific antibodies, and other novel modalities.
• Design and execute the buildout of chromatography and/or mass spectrometry methods for extended characterization, product release, stability, comparability, and in-process analytics.
• Make lab-based, data-driven contributions to project team and deliver results in a team-oriented setting and will work across scientific disciplines to drive programs through critical milestones.
• Represent key area function in cross-functional project teams, provide hands-on analytical support, technical oversight to portfolios.
• Collaborate and integrate scientific objectives associated with development of new/improved products or technology; contribute to internal scientific exchange and publications.
• Author, review lab notebook, analytical report, and analytical sections of regulatory filings. Primary author of external publications, presentations, regulatory documents and/or primary inventor of patents. Present at leading scientific conferences.
• May mentor/supervise a team of one or more, guide and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.

• Principal Research Scientist I — PhD in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) with 6+ years of industry experience
• Proficiency and direct experience in large biologics characterization and separation techniques, including various chromatography analytical methods (SEC/HIC/RPLC/IEC), intact or subunit mass analysis, peptide mapping.
• Knowledge in key analytical CMC areas, such as risk-based analytical development and method validation, CQAs, reference standard qualification, specifications, comparability.
• Familiarity with biologics CE, icIEF, biophysical assays, or binding and functional assays are plus.
• Working knowledge of lab automation, good written and oral communication skills, time management skills.
• Ability to work independently and collaboratively across functions.

• Senior Scientist II — PhD in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) with 4+ years of industry experience OR Master s degree in related fields with 8-10+ years of industry experience
• Proficiency and direct experience in large biologics characterization and separation techniques, including various chromatography analytical methods (SEC/HIC/RPLC/IEC), intact or subunit mass analysis, peptide mapping.
• Knowledge in key analytical CMC areas, such as risk-based analytical development and method validation, CQAs, reference standard qualification, specifications, comparability.
• Familiarity with biologics CE, icIEF, biophysical…