Senior Scientist , Biologics Analytical R&D, Analytical Development-Early Stage

Company Description

Abb Vie'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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Abb Vie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of Abb Vie s therapeutic biologic products. Our scope includes Abb Vie 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 commercial labs to support product launch.

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 Abb Vie s pipeline of innovative medicines. Careers in Abb Vie 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-Early Stage group within Biologics ARD is responsible for support of programs that are preparing for FIH clinical studies. The team leads Stage 1 method development, optimization, and validation. In collaboration with cross-functional partners, the team supports early phase formulation and process development studies. Key deliverables include product control strategies informed by analytical data and method understanding; robust analytical methods suitable for commercial QC labs;

comprehensive data packages that drive product and process understanding; clinical supplies release testing and stability studies to establish clinical product dating; substantial clinical trial application submission content.

• Effectively function as a senior research scientist, generating original technical ideas and research or development strategies.
• Demonstrate creative “out of the box” thinking to solve difficult problems and champion new analytical technologies to achieve project goals.
• Independently responsible for project activities within area of expertise while also contributing within the project team to the overall progress of the program.
• Deliver results in a team-oriented setting and willing to work across scientific disciplines to drive programs through critical milestones.
• Generate new scientific proposals and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.
• Effectively organize and present scientific plans and data.
• Author technical documents (e.g., methods, protocols, reports, etc.), scientific publications, presentations, and regulatory documents.
• Lead scientific experiments designed to screen platform analytical methods for incoming programs to the Biologics-ARD Early Stage group.

Senior Scientist I

• PhD (0+ years), Master’s Degree (8+ years), or Bachelor’s Degree (10+ years) in scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) with previous laboratory experience.
• Practical experience and strong knowledge of protein HPLC (e.g., SEC, IEX, HIC), capillary electrophoresis, and other separation techniques as applied to protein analysis.
• Experience developing and transferring bioassays and ELISAs to QC setting in support of early phase release and stability testing
• Must possess a solid understanding of protein chemistry and biochemistry, particularly as related to biologics drug development.
• Maintain a laboratory notebook in compliance with Good Laboratory/Manufacturing Practices.
• Demonstrated independent problem-solving…