The Analytical Development group within the Targeted LNP (tLNP) CMC Team at AbbVie is dedicated to advancing state-of-the-art analytical capabilities for mRNA-lipid nanoparticle therapeutics. Our team provides critical support across drug substance (DS) and drug product (DP) manufacturing, drug product formulation, and the development and implementation of robust analytical methodologies to ensure the quality, safety and integrity of tLNP genetic medicines. We leverage advanced biophysical, separations, and mass spectrometry techniques to deeply characterize intact LNP particles. We foster close collaborations with cross-functional colleagues in CMC, drug product formulation, and external partners, and are currently growing a world-class team of scientists who will be instrumental in building and deploying the analytical toolbox necessary to deliver high-quality, innovative tLNP medicines to patients.

Position Description: 

As a Liquid Chromatography (LC) Scientist within the Analytical Development team of AbbVie’s Targeted LNP (tLNP) CMC organization, you will support the development, optimization, qualification, transfer, and lifecycle management of LC-based analytical methods supporting tLNP programs.

The role will focus on LC methods used to evaluate the different modalities and components that comprise tLNP products, including monoclonal antibodies (mAbs), lipids, Linearized DNA (LDNA), mRNA, and LNP/tLNP. The successful candidate will have strong hands-on experience developing and troubleshooting chromatographic methods, such as ion-pair reversed-phase (IPRP), reversed-phase LC (RPLC), ion-exchange chromatography (IEX), size-exclusion chromatography (SEC), and other relevant LC techniques. The primary mission of this role is to independently develop and troubleshoot robust LC methods supporting analytical characterization, release, stability, and comparability assessment of tLNP components and products.

This individual is expected to maintain a strong laboratory presence while providing technical leadership in chromatographic method development and problem solving. The candidate will also collaborate across the global Analytical CMC organization and with R&D and CMC partners, including Discovery, Preclinical Safety, Process Chemistry, Process Engineering, Drug Product Development, Quality Assurance, and CMC Regulatory Affairs.

Responsibilities

• Serve as an LC focused Scientist, design, develop, optimize, and execute LC-based methods supporting release, stability, characterization, comparability, and in-process testing.
• Develop and optimize chromatographic methods for multiple tLNP-related modalities, including lipids, mAbs, LDNA, mRNA, and LNP/tLNP. Experience in one or more relevant modalities is expected; the successful candidate will expand their expertise in these related modalities through collaboration and training.
• Apply a strong understanding of chromatographic separation principles to method development, including investigation of critical method parameters, selectivity, resolution, peak shape, recovery, and overall method performance.
• Lead root-cause investigations into chromatographic performance, sample preparation, instrumentation, column chemistry and method robustness.
• Maintain a strong laboratory presence and demonstrate a high level of scientific initiative, creativity, independence, and productivity.
• Develop robust analytical methods by systematically evaluating key method variables and applying Design of Experiments (DOE) approaches when appropriate.
• Lead or support method qualification, transfer, implementation, and lifecycle management of LC-based analytical methods.
• Provide technical guidance and troubleshooting support for LC testing performed internally and at external CDMOs and contract testing laboratories.
• Analyze and interpret experimental data, identify trends, draw scientifically sound conclusions, and clearly communicate findings and recommendations.
• Collaborate effectively with analytical, process development, formulation, quality, regulatory, and other cross-functional partners.
• Contribute to continuous improvement of analytical capabilities by evaluating and implementing new chromatographic technologies and approaches.
• Prepare and review technical reports, methods, protocols, presentations, and other analytical documentation.
• Ensure laboratory activities comply with applicable AbbVie safety, quality, data integrity, and regulatory requirements.