Senior Scientist I, Biologics Analytical R&D, CMC Biologics Development
About The Position
AbbVie Biologics Analytical Research & Development is a global analytical sciences organization responsible for CMC analytical activities supporting the development of AbbVie pharmaceutical products, from discovery candidate selection through analytical method transition 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 Senior Scientist I serves as a subject matter expert in biologics analytical research and development and leads phase-appropriate analytical development strategies for biologics characterization. The role builds extended characterization methods and contributes hands-on scientific and technical support to cross-functional programs, with responsibilities spanning analytical investigations, scientific collaboration, documentation, regulatory filings, and external scientific communications.
Requirements
- PhD in a scientific discipline such as Analytical Chemistry, Biochemistry, or Biology; alternatively, a BS or equivalent education with 10+ years of experience, or an MS or equivalent education with 8+ years of experience.
- Direct, hands-on experience in mass spectrometry-based characterization of biologics, including intact or subunit analysis, peptide mapping, and disulfide bond mapping.
- Working knowledge of mass spectrometry coupled with chromatographic separation techniques and complementary separation-based analytical methods, including SEC, HIC, HILIC, and RPLC.
- Good written and oral communication skills.
- Good time management skills.
- Ability to work independently and collaboratively across functions.
Nice To Haves
- Familiarity with biologics CE, icIEF, biophysical assays, or binding and functional assays.
Responsibilities
- Act as a subject matter expert in BioARD and lead phase-appropriate analytical development strategies for characterizing biologics, including ADC, PDC, AOC, fusion proteins, multispecific antibodies, and other novel modalities.
- Build out biotherapeutics extended characterization methods to support 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 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.
- Independently drive scientific investigations.
- Collaborate on scientific objectives related to developing new or improved products and technologies, 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.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
