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

AbbVie•North Chicago, IL

About The Position

AbbVie Biologics Analytical Research & Development (Biologics Analytical R&D) is a global analytical sciences organization responsible for CMC analytical activities related to development of AbbVie's pharmaceutical products, from discovery candidate selection through analytical method and testing transitions to commercial labs. The Biologics Characterization group develops advanced analytical techniques for in-depth characterization of therapeutic proteins and other novel biologic molecules. The Principal Research Scientist I will serve as a subject matter expert in BioARD and lead phase-appropriate analytical development strategies for biologics characterization, including novel modalities. The role designs and executes extended characterization methods, provides hands-on analytical support and technical oversight, and contributes to cross-functional development programs and scientific objectives. It may include mentoring or supervising one or more team members and accountability for their effective performance.

Requirements

Bachelor's degree or equivalent education with 14 or more years of experience; master's degree or equivalent education with 12 or more years of experience; or Ph.D. in a scientific discipline such as Analytical Chemistry, Biochemistry, or Biology, typically with 6 or more years of industry experience.
Demonstrated proficiency and substantial hands-on experience in mass spectrometry-based characterization of biologics, including intact/subunit analysis, peptide mapping, and disulfide bond mapping.
Hands-on experience with mass spectrometry 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, and icIEF.
Knowledge of key analytical CMC areas, such as risk-based analytical development and method validation, CQA assessment, reference standard qualification, and comparability studies.
Working knowledge of laboratory automation.
Good written and oral communication skills and time-management skills.
Ability to work independently and collaboratively across functions.

Nice To Haves

Familiarity with biophysical assays or binding and functional assays.

Responsibilities

Act as a BioARD subject matter expert and lead phase-appropriate analytical development strategies for biologics characterization, including ADC, PDC, AOC, fusion proteins, multispecific antibodies, and other novel modalities.
Design and execute buildout of biotherapeutics extended characterization methods to facilitate in-process analytics, batch release and stability, reference standard qualification, and comparability studies.
Make lab-based, data-driven, phase-appropriate contributions to project teams and deliver results in a team-oriented setting.
Work across scientific disciplines to drive programs through critical milestones.
Represent the functional area on cross-functional project teams and provide hands-on analytical support and technical oversight to portfolios.
Collaborate on scientific objectives associated with development of new or improved products and technology, and contribute to scientific exchange and publications.
Author and review laboratory notebooks, analytical reports, and analytical sections of regulatory filings.
Serve as primary author of external publications, presentations, and patents, and present at leading scientific conferences.
May mentor or supervise one or more team members, guide and evaluate their performance, and be accountable for effective team or individual performance.