About the job
Join Our Team:
The Analytical Development team within the Targeted LNP (tLNP) CMC Team at AbbVie is committed to pioneering cutting-edge analytical methodologies for mRNA-lipid nanoparticle therapeutics. Our group plays a vital role in supporting both drug substance (DS) and drug product (DP) manufacturing, drug product formulation, and the creation of robust analytical techniques to guarantee the quality, safety, and integrity of tLNP genetic medicines. Utilizing advanced biophysical, separation, and mass spectrometry methods, we meticulously characterize intact LNP particles. We emphasize collaboration across CMC, drug product formulation, and external partners, and are in the process of expanding a world-class team of scientists essential for developing the analytical tools needed to deliver high-quality, innovative tLNP therapies to patients.
Position Overview:
AbbVie’s Targeted LNP (tLNP) CMC Analytical Development group is on the lookout for a Stability Coordinator to manage the release and stability programs that support the clinical development of mRNA-LNP medicines. In this position, you will coordinate all aspects of stability testing with external CDMOs and internal teams, ensuring the integrity of routine product release and stability data, leading investigations, and coordinating technical troubleshooting when analytical issues occur. You should also foster productive collaborations with the global Analytical CMC organization and cross-functional R&D partners such as Discovery, Pre-Clinical Safety, Process Chemistry, Process Engineering, Drug Product Development, and Quality Assurance and CMC-Regulatory.
Key Responsibilities:
- Act as the primary liaison for stability and release testing of tLNP drug substance and drug product at external CDMO partners.
- Oversee and monitor routine release and stability studies for DS and DP, including the assessment of assay performance.
- Lead investigations into out-of-specification or atypical stability or release results; provide analytical troubleshooting, coordinate confirmatory testing, and facilitate root cause analysis.
- Compile and trend stability data, aiding in shelf-life assignments, comparability studies, and regulatory submissions.
- Work collaboratively with analytical method owners, QA, Regulatory, and external partners to identify, communicate, and resolve analytical method and data challenges.
- Possess a history of driving continuous improvement in analytical or stability programs, such as assay harmonization, implementing innovative technologies, or enhancing efficiency and compliance.
- Exhibit strong project management skills, including timeline planning, risk mitigation, and proactive engagement with internal and external stakeholders.

