Principal Research Scientist I, Biologics Analytical Research and Development, CMC Biologics Development Full-time

AbbVie Biologics Analytical Research & Development

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience – and products and services in our Allergan Aesthetics portfolio.

AbbVie 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 AbbVie's pharmaceutical products. Our scope includes AbbVie'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 AbbVie's pipeline of innovative medicines. Careers in AbbVie 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 AbbVie Analytical R&D team and can offer exciting and rewarding career opportunities for these candidates.

Responsibilities:

• Act as a subject matter expert in BioARD, lead phase-appropriate analytical development strategies for biologics characterization including ADC, PDC, AOC, fusion proteins, multi-specific antibodies, and other novel modalities.
• Design and execute the buildout of biotherapeutics extended characterization methods, to facilitate in-process analytics, batch release/stability, RS qualification, and comparability study.
• Make lab-based, data-driven, and phase-appropriate 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 scientific exchange and publications.
• Author, review lab notebook, analytical report, and analytical sections of regulatory filings. Primary author of external publications, presentations, and 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.

Qualifications

• BS or equivalent education with 14+ years of experience; MS or equivalent education with 12+ years of experience; PhD in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) with typically 6+ years of industry experience, is required.
• Demonstrated proficiency and substantial hands-on experience in mass spectrometry-based characterization of biologics, including intact/subunit analysis, peptide mapping, disulfide bond mapping, etc., as well as hands-on experience in mass spec data processing and interpretation using various MS software platforms.
• Strong working knowledge and familiarity with separation-based analytical techniques, including SEC, HIC, HILIC, RPLC, IEX, CE, icIEF, etc.
• Knowledge in key analytical CMC areas, such as risk-based analytical development and method validation, CQAs assessment, reference standard qualification, comparability study.
• Familiarity with 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.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.