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

AbbVie•North Chicago, IL

4h•$124,500 - $236,500

About The Position

AbbVie Biologics Analytical Research & Development (Biologics Analytical R&D) is a global analytical sciences organization responsible for CMC analytical activities supporting development of AbbVie pharmaceutical products. Its work spans a diverse pipeline of therapeutic biologics, from discovery candidate selection through analytical method transfer and testing in commercial laboratories. 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 serves as a subject matter expert in biologics characterization and leads phase-appropriate analytical development strategies for biologics, including novel modalities. The role designs and executes extended characterization methods, contributes to cross-functional development programs, and provides hands-on analytical support and technical oversight. It also contributes to scientific exchange, regulatory documentation, external publications, presentations, and patents. The position may mentor or supervise one or more team members and be accountable for their 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 PhD 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 of separation-based analytical techniques, including SEC, HIC, HILIC, RPLC, IEX, CE, and icIEF.
Knowledge of analytical CMC areas, including 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, binding assays, or functional assays.

Responsibilities

Act as a subject matter expert in BioARD and lead phase-appropriate analytical development strategies for characterization of biologics, 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 and stability, reference standard qualification, and comparability studies.
Make lab-based, data-driven, and phase-appropriate contributions to project teams, deliver results in a team-oriented setting, and work across scientific disciplines to advance programs through critical milestones.
Represent the function in cross-functional project teams and provide hands-on analytical support and technical oversight to portfolios.
Collaborate on scientific objectives related to developing new or improved products or 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 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.