Senior Scientist , Analytical Development - Mass Spectrometry tLNP CMC

Job Description

The Analytical Development group within the Targeted LNP (tLNP) CMC Development Team at Abb Vie is dedicated to advancing state‑of‑the‑art analytical capabilities for tLNP therapeutics development. The team provides critical support to tLNP drug substance, drug product, and formulation development, leveraging advanced biophysical, separation, and mass spectrometry techniques to deeply characterize antibodies, mRNA, lipids, and intact LNP particles.

As the mass spectrometry SME within the Analytical Development group, you will work in an innovative analytical research and development lab and develop LC‑MS methods 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 and will 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.

• 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’ poly
  
  A 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, documenting experimental procedures and results in an electronic laboratory notebook (ELN).
• Author and review regulatory submission documents, such as IND and comparability studies.

• 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’ poly
  
  A tail LC‑MS analysis is preferred.
• Proficient in operating and maintaining mass spectrometry equipment, particularly LC‑MS systems, with experience in troubleshooting and maintaining LC‑MS instruments, including tasks like changing and cleaning interfaces.
• Experience with LC‑MS data acquisition and analysis software such as XCalibur, Protein Metrics, Free Style, Skyline, Bio Pharma Finder, and Mass Lynx.
• 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.

• Compensation range:
  The stated range is the possible base pay that Abb Vie believes in good faith it will pay for this role. Individual compensation within this range will depend on factors such as geographic location and may be higher or lower than the posted range and may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and a 401(k) to eligible employees.
• Eligibility to participate in short‑term incentive programs.
• Notes:
  No amount of pay is considered wages or compensation until such amount is earned, vested, and determinable. The bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remain at Abb Vie’s sole and absolute discretion until paid.

Abb Vie 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.