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

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

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

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.
• Statistic