The Analytical Development group within the Targeted LNP (tLNP) CMC Development Team at AbbVie is dedicated to advancing state-of-the-art analytical capabilities for tLNP therapeutics development. Our team provides critical support to tLNP drug substance, drug product, and formulation development. We leverage advanced biophysical, separation, and mass spectrometry techniques to deeply characterize antibodies, mRNA, lipids, and intact LNP particles. We are building a strong team of scientists who will be instrumental in developing and deploying the analytical toolbox needed to deliver high-quality, innovative tLNP medicines to patients.

Position Description: 

As the mass spectrometry SME within the Analytical Development group of tLNP CMC Development team, you will work in an innovative analytical research and development lab and develop LC-MS method for characterizing biotherapeutic products to support tLNP development, with an emphasis on mRNA and oligonucleotide analysis. The successful candidate will have hands-on analytical method development experience of LC-MS analysis. Additionally, the candidate must foster productive collaborations within the global Analytical CMC organization and with R&D cross-functional partners such as Discovery, Process Chemistry, Process Engineering, Drug Product Development, and Quality Assurance and CMC-Regulatory Affairs. 

Responsibilities

• Operate, maintain, and troubleshoot mass spectrometry (Orbitrap, TOF) and liquid chromatography platforms, along with general laboratory equipment.
• Document instrument performance, organize regular maintenance, and coordinate with service engineers during maintenance and troubleshooting activities.
• Lead and execute characterization activities to evaluate and elucidate critical quality attributes of mRNA, such as 5’ capping efficiency, 3’ polyA tail distribution, and oligonucleotide sequence mapping.
• Provide analytical support for cross-functional teams, including formulation development, upstream/downstream process development, and manufacturing to solve drug development challenges.
• Proactively advance LC-MS characterization of biotherapeutics by developing innovative techniques that address evolving developmental needs and improve operational efficiency.
• Independently conduct sample preparation and LC-MS analyses in compliance with SOPs, and document experimental procedures and results in electronic laboratory notebook (ELN).
• Author and review regulatory submission documents, such as IND and comparability study.