Senior Research Scientist II / Principal Research Scientist I, Biologics Analytical R&D

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Group:

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. We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines. Careers in AbbVie Biologics Analytical R&D provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies.

The biologics characterization group develops state-of-the-art analytical techniques for in-depth characterization of therapeutic proteins and other novel biologic molecules using mass spectrometry and other advanced analytical techniques. We are looking for diverse candidates with strong scientific and leadership experience to join the AbbVie Analytical R&D team and can offer exciting and rewarding career opportunities for these candidates.

Key Responsibilities

• Subject matter expert in establishing development of novel analytical methods to characterize peptides, oligonucleotides, ADCs, and novel antibody therapeutics, including HPLC, LC-MS, CD, DLS, SEC-MALS, ELISA/SPR.
• Contribute to phase-appropriate buildout of analytical methods for extended characterization, product release, stability, comparability, and in-process analytics.
• Guide and support assay development from development, optimization through validation.
• Serve as a key scientific and technical representative on cross-functional teams; collaborates and integrates scientific objectives associated with development of new/improved products or technology.
• Effectively function as an analytical scientist, generating original technical ideas and research or development strategies.
• Make significant contributions to project team and deliver results in a team-oriented setting and will work across scientific disciplines to drive programs through critical milestones.
• Generate new scientific proposals and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.
• Author, review lab notebook, analytical report, and analytical sections of regulatory filings. Primary author of publications, presentations, regulatory documents and/or primary inventor of patents. Present at leading scientific conferences.
• May mentor/supervise a team of one or more and guide and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.

Qualifications

• PhD (with 4+ years' experience, Sr Research Scientist II; with 6+ years' experience, Principal Research Scientist I) in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) with previous laboratory experience.
• Well versed in analytical techniques including but not limited to HPLC, LC-MS, CD, DLS, SEC-MALS, ELISA/SPR.
• Demonstrated experience with peptides and/or oligonucleotides method developments and optimization is strongly preferred
• Deep understanding and hands-on experience with biophysical-based and/or mass spectrometry-based higher order structures (HOS) characterizations strongly preferred
• Demonstrated experience of lab automation (Lynx, Hamilton, Tecan, etc.) is a strong plus
• Practical understanding of fit-for-purpose and stage-appropriate method development, risk assessment and control strategy in Analytical Development setup
• Demonstrate independent problem-solving ability in science and technical proficiency.
• Strong data and time organization/management skills coupled with strong interpersonal and effective communication skills for facilitating collaborations with a demonstrated ability to lead cross functional process development teams.

Additional Information

Applicable only to applicants