Cell Therapy CMC Lead

Job Summary

Leading the CMC activities for strategic assets, the full-time salaried Cell Therapy CMC Lead will define and implement integrated CMC asset strategies, manage cross-functional teams, and ensure alignment with regulatory and quality standards while working onsite in Northbrook, IL, with the option for remote work from anywhere in the US.

Key responsibilities

• Define and implement integrated CMC asset strategies aligned with product profiles and lifecycle objectives
• Lead cross-functional teams to convert CMC strategies into actionable plans with clear milestones and resource requirements
• Serve as the primary CMC interface for governance bodies, ensuring alignment across functions and effective risk management

Required qualifications

• Advanced degree in sciences, engineering, pharmaceutical sciences, or a related discipline; doctoral-level training preferred
• Minimum of 8 years of relevant experience with a PhD, 12 years with an MS, or 15 years with a BS in drug development programs
• Demonstrated success in product development and CMC leadership with accountability for strategy and execution
• Broad understanding of the end-to-end development continuum, including CMC, regulatory strategy, and commercialization
• Strong financial acumen with experience in budget stewardship and resource prioritization