Senior Scientist I, Analytical Development - Mass Spectrometry tLNP CMC

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.
• 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.