The Principal Scientist II will be an integral part of the Analytical Development team in the Operations – Product Development Science and Technology – Biologics division. The role involves supporting analytical aspects of biologics products with a focus on advancing AbbVie’s late-stage clinical programs. This position calls for an individual with a strong technical analytical background, demonstrated leadership skills and the ability to effectively communicate and work cross-functionally.
Responsibilities:
- Lead and mentor scientists specializing in separation-based assays including HPLC and capillary electrophoresis for sample testing to support biologics mab and DS process development, characterization, validation as well as GMP manufacturing investigation activities.
- Serve as the process analytics lead for mab and DS in AbbVie's CMC teams, supporting late-stage biologics pipeline assets. Act as a partner to the process development groups. Balance stakeholder expectations to ensure effective collaboration.
- Serve as the subject matter expert for separation-based methods, providing expertise and support for method development, execution, and troubleshooting.
- Evaluate and select effective analytical technologies and methods to meet program needs. Support automation and development of high-throughput analytical methods and drive timely delivery of high-quality testing results.
- Participate in the preparation and review of technical documents for late-stage programs. Author and review analytical sections of IND/BLA filings, provide response support to agency information requests. Ensure all submissions comply with regulatory requirements and industry standard.
- Collaborate with other analytical teams in R&D and PDS&T on program transition, workflow and program strategic alignment. Provide guidance to peers on project management, analytical strategy development, and technical skills related to separation techniques.
- Communicate project strategies, issues, and risks to relevant teams. Promote proactive risk resolution within and across functional areas to advance project objectives.
- Demonstrate scientific excellence, advance science and innovation. Implement novel analytical techniques to enhance method robustness and expand analytical capabilities.