Principal Research Scientist I, Biologics Analytical R&D (External Programs)

Role Summary

Principal Research Scientist I, Biologics Analytical R&D (External Programs) leads analytical development for externally sponsored programs within AbbVie Biologics ARD. The role serves as the analytical lead on internal CMC teams and coordinates with external partners on method development, validation/transfer, and testing of clinical supplies to meet program deliverables. In collaboration with cross-functional partners, the role defines analytical strategies for formulation and process development and delivers robust analytical methods, release and stability data, product control strategies, and regulatory submission content.

Responsibilities

• As analytical lead, develop analytical strategies and communicate to Analytical R&D functions and CMC business partners for experimental execution in support of stability studies, product analytical control strategies, comparability studies and extended characterization of biologics.
• Collaborate with third party laboratories to ensure CMC timelines are met.
• Interpret and identify data trends in key analytical release and stability assays.
• Author and/or review key regulatory documents, laboratory data, technical memos and reports.
• Proactively advise and share knowledge/expert opinions with peers and senior management. Mentor peers in project management and development of analytical strategies.
• Demonstrate scientific excellence in analytical characterization of biologics internally and externally and build and foster an active network of consortia collaborations.
• Brainstorm ideas for continuous improvement activities and lead/participate in initiatives.
• Understand and adhere to corporate standards regarding code of conduct, safety, and GXP compliance.

Qualifications

• Required: BS (14+ years); MS (12+ years), or PhD (6+ years) in Chemistry, Biochemistry, or Biology with previous industry experience (6+ years) in a pharmaceutical laboratory setting.
• Preferred: Experience in project management/leadership of analytical development activities for biologic compounds (mAbs, antibody drug conjugates and/or fusion proteins).
• Preferred: Experience and strong knowledge of protein HPLC (e.g., SEC, IEX, HIC), capillary electrophoresis, and other separation techniques as applied to protein analysis.
• Preferred: Demonstrated scientific writing skills and excellent verbal communication skills.
• Preferred: Experience in laboratory systems (LIMS, CDS, ELN).
• Preferred: Statistical knowledge and experience are preferred, e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies.

Skills

• Interact well with diverse groups within function and maintain strong working relationships with internal and external collaborators to enable higher performance.
• Learns fast, grasps the essence and can change course quickly where indicated.
• Raises the bar and is never satisfied with the status quo.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.