💼 About This Role

You'll lead process validation and risk management strategies for commercial manufacturing at a clinical-stage vaccine company. You'll ensure regulatory compliance and lifecycle management across end-to-end processes. This role offers the chance to build frameworks from the ground up in a mission-driven organization.

🎯 What You'll Do

• Lead process validation (PPQ, CPV, lifecycle) for commercial programs
• Develop and implement risk management frameworks with Quality
• Support commercialization lifecycle and continued process verification
• Collaborate with cross-functional teams and external CMOs

📋 Requirements

• PhD with 9+ years, MS with 11+, or BS with 14+ in relevant field
• Experience in biologics/vaccine manufacturing and process validation
• Knowledge of quality risk management (ICH Q9) and regulatory expectations
• Leadership in matrixed or cross-functional team environments

🎁 Benefits & Perks

• 🏥 Comprehensive benefits package
• 💰 Equity component
• ✈️ Travel 10-30% domestic and international