Avenzo Therapeutics

Director

• Provide strategic and technical leadership for outsourced biologics drug substance development and manufacturing across clinical and commercial stages
• Lead upstream and downstream process development activities from early development through commercialization
• Serve as technical lead and subject matter expert for external CDMO/CMO partnerships, including selection, governance, performance management, and manufacturing oversight
• Oversee process characterization, technology transfer, process validation (PPQ), scale-up, and commercial readiness activities
• Provide technical oversight of manufacturing operations, including process performance, manufacturing readiness, deviations, investigations, change controls, and process improvements
• Lead technical troubleshooting, risk assessments, root cause investigations, and mitigation strategies
• Drive technology transfer strategies, comparability assessments, process control strategies, and manufacturing documentation
• Partner with Process Development, Analytical Development, Quality, Regulatory, Supply Chain, Program Management, and external partners
• Support regulatory submissions and health authority interactions, including IND, IMPD, BLA, and MAA CMC content and responses
• Ensure compliance with cGMP requirements, global regulatory expectations, and internal quality standards
• Maintain inspection and commercial readiness
• Provide technical recommendations, risk assessments, and strategic guidance to senior leadership
• Report to the Senior Vice President, Chemistry Manufacturing and Controls (CMC)

Director, Biologics Process Development