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

Overview: 

AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for CMC analytical activities related to the development of AbbVie's therapeutic biologic products.  Our scope includes AbbVie's diverse pipeline of innovative therapeutic biologics medicines, including monoclonal antibodies, antibody drug conjugates (ADC), and other novel modalities, and spans from the selection of Discovery candidate molecules through the transition of analytical methods and testing to operations partners for late stage development.  We are building a world-class team of scientists and leaders who will drive the advancement of industry-leading analytical capabilities and make meaningful contributions to advance AbbVie's pipeline of innovative medicines.  Careers in AbbVie Biologics ARD provide unique opportunities to work with global and cross-functional teams to drive exceptional science and innovative product development strategies.

The Analytical Development – External Programs group within Biologics ARD is responsible for early development (through clinical proof of concept) of programs with outsourced analytical activities.  The candidate will serve as analytical lead on internal CMC teams and will work with external parties on method development, optimization, validation/transfer, and testing of clinical supplies to meet analytical deliverables for their given development programs.  In collaboration with cross-functional partners, the lead will define analytical strategies for formulation and process development studies.  Key deliverables include robust analytical methods, clinical supplies release testing and stability studies to establish clinical product dating, product control strategies informed by analytical data and method understanding, comprehensive data packages that drive product and process understanding, and regulatory submission content. 

Major 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:

• MS (12+ years), or PhD (6+ years) in Chemistry, Biochemistry, or Biology with previous work experience (6+ years) in a pharmaceutical laboratory setting.
• Preferred candidate should have experience in project management/leadership of analytical development activities for biologic compounds (mAbs, antibody drug conjugates and/or fusion proteins).
• Experience and strong knowledge of protein HPLC (e.g., SEC, IEX, HIC), capillary electrophoresis, and other separation techniques as applied to protein analysis.  
• Demonstrated scientific writing skills and excellent verbal communication skills. 
• 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.

Key AbbVie Competencies:

• 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.

Level and compensation will be commensurate with experience.