The Senior Scientist I will be an integral part of the Analytical Development team in the Operations – Product Development Science and Technology – Biologics division. The role involves managing all analytical aspects of biologics products at different stages of their drug development lifecycle with a focus on advancing AbbVie’s pre-clinical and early clinical programs. The individual will play a key role in analytical method development, method transfer, troubleshooting, specification setting and justification, stability studies, and regulatory filings. Collaboration with other analytical teams, quality control, bioprocess development, and R&D groups is a crucial part of this role to meet business objectives and program milestones.

Responsibilities:

• Execute and/or lead method development and analytical testing to support pipeline programs using analytical separation techniques including HPLC/UPLC, electrophoresis, etc.
• May initiate new areas of investigation that are scientifically meaningful, reliable, and can be incorporated directly into a research or development program. Demonstrates high proficiency across a wide range of relevant technologies.
• Partner with other groups in the Analytical Development team to provide analytical support for pipeline programs using traditional and advanced analytical techniques, including but not limited to ELISA, bioassays, mass spectrometry, biophysical, spectrophotometric and compendial methods.
• Participate in cross-functional, multi-site meetings / projects and coordinate analytical activities that need to be supported in the Analytical Development team for pipeline programs.
• Participate in the preparation and review of internal technical documents to ensure compliance.
• Author regulatory submissions and provide scientifically sound responses to agency deficiency letters.
• Evaluate and implement novel analytical techniques to expand analytical capabilities in the Analytical Development team
• Mentor or supervise junior members in the same team.