Senior Manager – Quality Operations

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🔥 14 minutes ago

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BrainChild Bio

11 - 50 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $300k Grant - BrainChild Bio on 2025-01

Biotechnology • Pharmaceuticals

<BrainChild Bio> is a clinical-stage biotechnology company developing CAR T-cell therapies targeting tumors in the central nervous system (CNS). The company prioritizes pediatric brain tumors while extending its platform to adult indications such as glioblastoma and brain metastases, aiming to advance novel cell therapies through the clinic and translate its science broadly to improve outcomes for children and adults with CNS cancers.

📋 Description

• Lead quality oversight of outsourced clinical and manufacturing operations supporting cell therapy programs from patient collection through product administration • Establish and maintain a robust supplier quality management program • Oversee GxP compliance across external partners • Drive quality risk management and inspection readiness • Partner cross-functionally to ensure reliable and safe product supply across various programs

🎯 Requirements

• Quality oversight for GxP Partners, Suppliers & service providers (CDMOs, CROs, central laboratories, apheresis centers, logistics providers, and clinical sites)

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