Senior Scientist - II, Analytical R&D; Lipids SME

Company Description

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

The Analytical Development group within the Targeted LNP (tLNP) CMC Team at Abb Vie 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 a Lipids SME within the Analytical Development team of Abb Vie’s Targeted LNP (tLNP) CMC organization, you will be a technical leader for the development, optimization, and qualification of the analytical methods to characterize and control lipid components used in tLNP. The successful candidate will ideally possess experience in lipids control strategies and have practical expertise in developing analytical methods for lipid quantitation, purity evaluation, and identification of impurities or degradation products.

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.

• 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 lipid characterization and quality control.
• Develop analytical control strategies for individual lipid components as well as for the lipid components in the final tLNP drug product.
• Support 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.
• Demonstrate 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.
• Embrace the ideas of others, nurture innovation and manage innovation to reality.
• Understand and comply with Abb Vie safety, quality and regulatory policies and government regulations.

• Senior Scientist I:
  Analytical Chemistry degree (or related field). BS with 10+ years, MS with 8+ years, and PhD with 0+ years industry 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.
• Demonstrated understanding of the lipids structure and possible degradation pathways.
• Demonstrated understanding of the lipids manufacturing process…