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 Abb Vie’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.

• 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 Abb Vie's CMC teams, supporting late-stage biologics pipeline assets and acting as a partner to the process development groups.
• 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 and provide response support to agency information requests, ensuring all submissions comply with regulatory requirements and industry standards.
• Collaborate with other analytical teams in R&D and PDS&T on program transition, workflow, and program strategic alignment, providing 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 and promote proactive risk resolution within and across functional areas to advance project objectives.
• Demonstrate scientific excellence, advance science and innovation, and implement novel analytical techniques to enhance method robustness and expand analytical capabilities.

• PhD in chemistry, biology, biochemistry, chemical engineering, or related technical discipline with a minimum of 8+ years (PhD) of professional experience in a 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 authoring and reviewing regulatory submissions and responding to agency information requests.
• Strong people leadership skills with a 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.
• Agility to quickly comprehend and adapt to new situations with an open mindset and can‑do attitude, demonstrating flexibility for evolving project needs.
• Critical thinking and strong troubleshooting/problem‑solving skills with high attention to detail.
• Ability to lead and manage multiple projects of significant scope and complexity while meeting all deliverables and timelines.
• Independence, self‑motivation, and proactive nature thriving in a fast‑paced team environment.

• The compensation range described below is the range of possible base pay compensation that the Company believes, in good faith, it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and may ultimately be more or less than the…