Associate Director, Biopharmaceutical Process Technology

CSL seeks an Associate Director, Process Technology to lead late-stage development and commercialization of biopharmaceutical manufacturing processes. You will oversee technology transfer, scale-up, and process validation for biologics, partnering with R&D, manufacturing, and quality to ensure robust, compliant processes. Responsibilities include driving process optimization and continuous improvement, evaluating new technologies, managing a technical team, and troubleshooting complex manufacturing issues. You will ensure cGMP and regulatory expectations are met while mentoring talent and supporting global sites to reliably deliver high-quality therapies to patients worldwide.

Responsibilities

• Lead design, scale-up, and optimization of biologics manufacturing processes
• Oversee technology transfer and process validation to global manufacturing sites
• Drive continuous improvement and implementation of new process technologies
• Ensure compliance with c
• GMP, regulatory, and quality standards
• Troubleshoot complex technical and manufacturing issues
• Manage, coach, and develop a high-performing technical team
• Collaborate with R&D, quality, and operations on late-stage development
• Support regulatory filings and responses with robust technical documentation
• Monitor process performance and implement control strategies
• Contribute to network strategy for capacity, robustness, and tech innovation

Required Skills

• Biologics process development
• Tech transfer and scale-up
• Process validationc
• GMP compliance
• Bioreactor and downstream operations
• Process characterization
• Statistical analysis/DOERegulatory documentation (CMC)
• Technical leadership
• Continuous improvement/lean principles