Senior Scientist I, Biologics Drug Product Development

Role Summary

Senior Scientist I, Biologics Drug Product Development, located in North Chicago, IL. We are seeking an accomplished scientist with a proven track record in biologics formulation and process development, and characterization to join the Bio DPD team and collaborate with discovery research, analytical R&D, bioprocess development, and other stakeholders.

Responsibilities

• Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
• Support scale-up and technology transfer activities to internal and external manufacturing sites.
• Drive the implementation of automation and high throughput screening technologies to accelerate biologics formulation development and enable efficient evaluation of multiple formulation variables.
• Keep abreast of the latest advances in biologics formulation and process technologies.
• Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and improve business processes.
• May represent the Bio DPD function in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC team.
• Effectively and timely communicates study plans, risks and mitigation plans to stakeholder and line management.

Qualifications

• Bachelors, Masters, or PhD in pharmaceutics, pharmaceutical sciences, chemistry, chemical engineering, or related disciplines with 8+ (Bachelors), 6+ (Masters), or 0+ (PhD) years of relevant industry experience.
• Proven ability to solve critical scientific problems.
• Hands-on experience with biologics formulation development and lyophilization.
• Hands-on experience with analytical and biophysical characterization of proteins and solid-state characterization methods.
• Experience with automation technologies and/or high-throughput screening methods for formulation development.
• Solid understanding of biologics degradation mechanisms and stabilization strategies.
• Hands-on experience with Design of Experiments (DoE), multivariate statistical analyses and data visualization tools.