Principal Research Scientist I, Biologics Analytical Research and Development, CMC Biologics Development at AbbVie · LumiJobs

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.
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.

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

Responsibilities

Benefits

Company

AbbVie

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