Principal Research Scientist II - Analytical Development

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.

• PhD in chemistry, biology, biochemistry, chemical engineering, or related technical discipline.  Minimum of 8+ years (PhD) of professional experience working in biotech/pharmaceutical setting.
• Proven experience managing and leading analytical development activities for late-stage biologic development, including mAbs, multi-specifics, antibody-drug conjugates, and fusion proteins.
• Expertise in protein and impurity analysis techniques such as HPLC, capillary electrophoresis, and other relevant methods. Experience with mass spectrometry and ELISA is a plus.
• Skilled in technical writing including experience in authoring, reviewing regulatory submissions and responding to agency information requests.
• Strong people leadership skills and demonstrated ability to foster an engaging, inclusive and collaborative team environment.
• Excellent communication and interpersonal skills, effectively managing relationships to enhance team decision-making.
• Ability to work effectively across functions, anticipating and addressing overall program development needs.
• Ability to quickly comprehend and adapt to new situations, with an open mindset and can-do attitude, demonstrating agility where necessary to address evolving project needs.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills. High attention to detail.
• Ability to lead and manage multiple projects of significant scope and complexity, while meeting all deliverables and timelines.
• An independent, self-motivated, proactive individual who thrives in a fast-paced team environment.