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CMC Quality Leadership:
- Provide strategic quality leadership as Quality representative on cross-functional teams.
- Review and approve CMC regulatory submissions and support health authority inspections.
Product Quality Strategy:
- Lead development of product quality and risk-based control strategies aligned with QbD and ICH.
- Oversee lifecycle management of specifications and analytical acceptance criteria.
QC Operations Oversight:
- Provide strategic oversight for QC support activities and outsourced operations.
- Oversee GMP sample lifecycle and sterility assurance programs.
BrainChild Bio
BrainChild Bio is a clinical-stage biotechnology company developing CAR T cell therapies for central nervous system tumors. The company prioritizes pediatric brain tumors with a pipeline extending to adult indications, and every team member directly impacts bringing therapies to patients.