Senior Scientist II – Principal Scientist I, Analytical R&D (Particle Characterization) Full-time

Particle Characterization Expert

The Analytical Development group within AbbVie's Targeted LNP (tLNP) CMC Team advances best-in-class analytical capabilities to deeply characterize mRNA-lipid nanoparticle therapeutics. We play an instrumental role in ensuring the quality, safety, and efficacy of tLNP genetic medicines by leveraging advanced biophysical, separation, and mass spectrometry techniques. As a Particle Characterization Expert, you will drive the development and implementation of robust characterization strategies for the intact drug product using a comprehensive suite of biophysical and analytical tools including DLS, NTA, AF4/MALS, TEM/CryoEM, DSF/DSC and other relevant technologies. We are looking for diverse candidates with strong scientific experience to join the Analytical R&D team and can offer exciting and rewarding career opportunities for these candidates. Additionally, the candidate must be able to foster productive collaborations within the global Analytical CMC organization and with R&D cross-functional partners such as Discovery, Pre-Clinical Safety, Process Chemistry, Process Engineering, Drug Product Development, and Quality Assurance and CMC-Regulatory Affairs.

Responsibilities:

• Effectively function as a principal research scientist, generating original technical ideas and research or development strategies.
• Develop, optimize, and execute characterization assays for the drug product (intact LNPs), including, but not limited to particle size, morphology, aggregation, and surface properties using platforms such as DLS, NTA, MALS, TEM/cryoEM, and CD.
• 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.
• Demonstrate scientific initiative and creativity in research or development activities and maintain a high level of productivity in the lab.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.
• Raises the bar and is never satisfied with the status quo.
• Understand and comply with AbbVie safety, quality and regulatory policies and government regulations.

Qualifications:

• Senior Scientist II: Analytical Chemistry degree (or related field). BS with 12+ years', MS with 10+ years', and PhD with 4+ years' industry experience.
• Principal Scientist I: Analytical Chemistry degree (or related field). BS with 14+ years', MS with 12+ years', and PhD with 6+ years' industry experience.
• Strong technical background in analytical chemistry, excellent analytical problem-solving skills. Capable of independently developing and troubleshooting analytical methods.
• Demonstrated expertise in troubleshooting, optimizing, and validating particle sizing and morphology methods (DLS, NTA, MALS, CryoEM, CD, DSC) for complex nanoparticle or biologic products.
• Prior responsibility for designing and leading DOE or comparability studies assessing the impact of process and formulation variables on LNP particle attributes.
• Familiarity with critical quality attribute (CQA) setting and the regulatory expectations for LNPs and nanoparticle-based drug products preferred.
• Experience with method qualification and transfer to external CDMOs; ability to troubleshoot analytical issues remotely and coordinate investigations.
• Working knowledge of forced degradation studies and the ability to analyze stability-related changes in LNP size, morphology, aggregation, or targeting moiety integrity.
• Strong data management and analysis skills, including proficiency with relevant software for particle analysis (e.g., Malvern Zetasizer, NanoSight NTA, Astra, cryoEM image processing, related software).
• Knowledge of preclinical and clinical formulation development principles relevant to lipid nanoparticle (LNP) formulations – demonstrated industry experience strongly preferred.
• Familiarity with the role that physicochemical properties play in drug delivery and formulation design.
• Demonstrate creative 'out of the box' thinking to solve difficult problems
• High-quality written and oral communication skills and ability to interact effectively with interdisciplinary scientists and engineers.