Senior Scientist I, Biologics Analytical R&D, CMC Biologics Development
AbbVie
Summary
AbbVie Biologics Analytical Research & Development (Biologics Analytical R&D) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of AbbVie's pharmaceutical products. Our scope includes AbbVie's diverse pipeline of innovative therapeutic biologic medicines and spans from the selection of Discovery candidate molecules through the transition of analytical methods and testing to commercial labs to support product launch.
Job description
The biologics characterization group develops state-of-the-art analytical techniques for in-depth characterization of therapeutic proteins and other novel biologic molecules using advanced, combined analytical techniques.
Key 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.
- 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.
- The ability to independently drive scientific investigations.
- 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.
Qualifications
- PhD in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology); BS or equivalent education and extensive 10+ years of experience; MS or equivalent education with 8+ years of experience.
- Direct and hands-on experience in mass spectrometry-based characterization of biologics, including intact/subunit analysis, peptide mapping, disulfide bond mapping, etc.
- Working knowledge of mass spectrometry coupled chromatographic separation techniques and complementary separation-based analytical methods, including SEC, HIC, HILIC, RPLC, etc.
- Familiarity with biologics CE, icIEF, biophysical assays, or binding and functional assays are plus.
- Good written and oral communication skills, and time management skills.
- Ability to work independently and collaboratively across functions.
Requirements
- PhD in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology); BS or equivalent education and extensive 10+ years of experience; MS or equivalent education with 8+ years of experience
- Direct and hands-on experience in mass spectrometry-based characterization of biologics, including intact/subunit analysis, peptide mapping, disulfide bond mapping
- Working knowledge of mass spectrometry coupled chromatographic separation techniques and complementary separation-based analytical methods, including SEC, HIC, HILIC, RPLC
- Good written and oral communication skills
- Time management skills
- Ability to work independently and collaboratively across functions
Benefits
- Paid time off
- Holidays
- Sick leave
- Medical, Dental & Vision
- 401(k)
- Short-term incentive programs
Company overview
AbbVie is a global biopharmaceutical company that discovers, develops, and markets advanced therapies for some of the world's most complex and serious diseases. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie has established itself as a leader in immunology, oncology, neuroscience, eye care, and virology. The company's flagship product, Humira (adalimumab), was one of the world's top-selling drugs for treating autoimmune conditions like rheumatoid arthritis and Crohn's disease. AbbVie maintains a robust pipeline of innovative medicines and has expanded its portfolio through strategic acquisitions, including Allergan in 2020. With research facilities across the United States and globally, AbbVie focuses on advancing science to improve patient outcomes while maintaining strong commercial operations worldwide. The company operates with a patient-centric approach and invests significantly in research and development to address unmet medical needs across multiple therapeutic areas.