Senior Principal Scientist

Job Summary

Serving as a senior scientific subject matter expert, the full-time Senior Principal Scientist will provide expert technical assessment and guidance on Chemistry, Manufacturing, and Controls (CMC) activities for innovative biologics, focusing on cell and gene therapy, while working remotely.

Key responsibilities

• Applies deep scientific expertise to CMC strategy discussions, including process and analytical development, manufacturing, and lifecycle management
• Develops data-driven technical recommendations balancing scientific rationale, regulatory expectations, and business priorities
• Provides oversight for external development and manufacturing partners, ensuring effective technical scope definition and risk mitigation

Required qualifications

• Advanced degree in a relevant scientific or engineering discipline preferred; Bachelor's degree with significant relevant industry experience will be considered
• 8+ years of relevant industry experience in CMC, process engineering, or pharmaceutical development
• 5+ years of experience in the cell and gene therapy field, serving as a senior scientific or technical expert
• Demonstrated experience with external development and manufacturing organizations, including technical due diligence and technology transfer
• Strong understanding of CMC principles across product and process development, regulatory requirements, and lifecycle management