Principal Research Scientist I - Biologics Analytical Research and Development, CMC Biologics Development
About The Position
AbbVie Biologics Analytical Research & Development is a global analytical sciences organization responsible for CMC analytical activities across the development of AbbVie pharmaceutical products, from discovery candidate selection through method and testing transfer to commercial laboratories. The biologics characterization group develops advanced analytical techniques for in-depth characterization of therapeutic proteins and other novel biologic molecules. This role provides scientific and technical leadership in phase-appropriate analytical development for biologics characterization, supporting product development and critical program milestones. The position also contributes to cross-functional scientific work, regulatory documentation, publications, presentations, and patents, and may mentor or supervise one or more team members.
Requirements
- BS or equivalent education with 14 or more years of experience; MS or equivalent education with 12 or more years of experience; or a PhD in a scientific discipline such as Analytical Chemistry, Biochemistry, or Biology with typically 6 or more years of industry experience.
- Demonstrated proficiency and substantial hands-on experience in mass spectrometry-based characterization of biologics, including intact and subunit analysis, peptide mapping, and disulfide bond mapping.
- Hands-on experience processing and interpreting mass spectrometry data using various MS software platforms.
- Strong working knowledge of separation-based analytical techniques, including SEC, HIC, HILIC, RPLC, IEX, CE, and icIEF.
- Knowledge of key 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, time management, and ability to work independently and collaboratively across functions.
Nice To Haves
- Familiarity with biophysical assays or binding and functional assays.
Responsibilities
- Serve as a subject matter expert in BioARD and lead phase-appropriate analytical development strategies for characterization of biologics, including ADCs, PDCs, AOCs, fusion proteins, multispecific antibodies, and other novel modalities.
- Design and execute development of extended characterization methods for biotherapeutics to support 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 and deliver results in a team-oriented setting, working across scientific disciplines to advance 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 related to developing new or improved products or technologies, and contribute to scientific exchange and publications.
- Author and review laboratory notebooks, analytical reports, and analytical sections of regulatory filings.
- Serve as a 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.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
Education Level
Ph.D. or professional degree
