About the Group : The Analytical Development group within the newly formed Targeted LNP (tLNP) CMC Team at AbbVie that 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 Overview: As a Lipids SME within the Analytical Development team of AbbVie’s Targeted LNP (tLNP) CMC organization, you will be responsible for leading the analytical activities relevant to lipids components. Develops, establishes and validates testing methods used to control individual lipid starting material and final assembled lipids component in the DP. Responsible for development and implementation of control strategies for individual lipid starting material and final assembled lipids component in the DP. Responsible for keeping work in compliance with cGMP, safety and regulatory requirements. Additionally, the candidate must 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: Act as an analytical lead for lipids component for tLNP projects Develop analytical control strategies for individual lipid component as well as for the assembled lipid components in the final tLNP drug product Effectively function as the lead subject matter expert for analytical methods related to lipid quantitation, purity assessment, and identification of impurities or degradation products. Develop, optimize, validate, and implement analytical methods for lipids quality control Oversee contract testing labs analytical testing of clinical supplies Facilitates and leads investigation for out of specification (OOS) and out of trend (OOT) results Prepares analytical sections of regulatory documents, protocols and reports Supporting formulation and manufacturing by ensuring consistent lipids quality Design experiments to understand and characterize lipids degradation pathways in the final tLNP drug product Train and mentor junior scientists in lipids related analytical methodologies Stay current on innovations, regulatory requirements, and industry best practices for tLNP lipid components quality control Generate new scientific proposals and lead those efforts Demonstrated ability to collaborate effectively with team members and a willingness to continuously learn new techniques to enhance and advance the analytical capabilities of the program 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 Understand and comply with AbbVie safety, quality and regulatory policies and government regulations
Leveling will be commensurate to experience: 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. Demonstrated CMC experience for small molecules / lipids from an analytical perspective Demonstrated understanding of synthetic chemistry process for the synthesis of small molecules or lipids Demonstrated understanding of the analytical strategy for critical quality attributes monitoring Demonstrated capability to design experiments to understand lipids degradation pathways and establish analytical methods to monitor degradants Extensive hands-on experience in analytical techniques for small molecules/lipids/ LNPs (e.g., LC-CAD, LC-MS, spectroscopy) Direct experience developing, qualifying, and transferring analytical methods Ability to coordinate and help trouble shoot analytical methods at external CDMOs or contract testing labs Hands-on experience with additional analytical techniques relevant to mRNA or LNP analysis is considered a plus Working knowledge of biosafety, data integrity, and compliance requirements for GxP-regulated testing and ICH guidelines Strong presentation and communication skills with the ability to explain data to technical