Senior Scientist I, Analytical Development - Mass Spectrometry tLNP CMC

Company Description

About AbbVie

AbbVie'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 AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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 Overview: 

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.

Qualifications

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a closely related field with 0-3 years of industry experience.
• Previous experience with mRNA, oligonucleotide, antibody, and LNP analysis by LC-MS is a strong plus.
• Experience in mRNA 5’ capping and 3’ polyA tail LC-MS analysis is preferred.
• Proficient in operating and maintaining mass spectrometry equipment, particularly LC-MS systems, and have experience in troubleshooting and maintaining LC-MS instruments, including tasks like changing and cleaning interfaces.
• Experience with LCMS data acquisition and analysis software, such as XCalibur, Protein Metrics, FreeStyle, Skyline, BioPharma Finder, and MassLynx.
• Organized, detail-oriented, and committed to maintaining proper documentation.
• Work independently while also collaborating effectively with a team of experts.
• Hands-on experience with additional analytical techniques relevant to mRNA or LNP analysis is a plus.
• Strong presentation and communication skills with the ability to explain data to technical and non-technical audiences.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requireme