Scientist II – Senior Scientist I, Analytical R&D (Electrophoresis SME) Full-time

Electrophoresis Sme

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.

As an Electrophoresis SME within the Analytical Development team of AbbVie's Targeted LNP (tLNP) CMC organization, you will be a technical leader for the development, optimization, and qualification of Electrophoresis related methods that measure the mRNA and tLNP. The successful candidate will have hands-on analytical method development experience for Electrophoresis related methods (e.g.,CE, cIEF,CZE). 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:

• Effectively function as a SME for Electrophoresis methods, generating original technical ideas and research or development strategies.
• Develop and optimize CE-LIF for assessing mRNA purity, qualify the methods for phase appropriate use
• Explore the potential of different electrophoresis methods to analyze mRNA-LNP size, degradation, purity and encapsulation efficiency
• Lead tech transfer, implementation and lifecycle management of Electrophoresis related methods (e.g., CE, icIEF,CZE)
• 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

Qualifications:

• Scientist II: Analytical Chemistry degree (or related field). BS with 7+ years', MS with 5+ years' industry experience.
• Senior Scientist I: Analytical Chemistry degree (or related field). BS with 10+ years', MS with 8+ years', and PhD with 0+ years' industry experience.
• Deep understanding of the Electrophoresis principle, familiar with PA800+ / BioPhase 8800 / Maurice instruments and have hands on experience on at least one of these three instruments
• Understand the effects of key variables on method performance and utilize DOE approaches to achieve robust method development
• Direct experience developing, qualifying, and transferring Electrophoresis related methods for at least one of the following modalities: mRNA, antibody, LNP
• Ability to coordinate and help trouble shoot Electrophoresis analysis work 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.
• Strong presentation and communication skills with the ability to explain data to technical and non-technical audiences.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.