Senior Scientist I, Biologics Drug Product Development

Role Summary

Senior Scientist I, Biologics Drug Product Development, located in North Chicago, IL. The role focuses on biologics formulation and process development, and characterization, contributing to product development and CMC teams with cross-functional collaboration.

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.
• 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.
• Solid understanding of biologics degradation mechanisms and stabilization strategies.
• Hands-on experience with Design of Experiments (DoE), multivariate statistical analyses and data visualization tools.

Preferred Qualifications

• Understanding of relevant cGMP and regulatory guidance.
• Experience with sterile manufacturing unit operations (freeze-thaw, mixing, filtration, filling, and freeze-drying) development, characterization, scale-up and technology transfer.
• Experience in managing third party manufacturers.
• Experience with quality risk management and drug product control strategies.