Executive Director, Process Engineering

Responsibilities

• Lead the Late-Stage Process Development function for Cell Therapies within the CTO, managing multiple development projects across several locations.
• Create and deploy global technical standards for cell therapy, focusing on process validation, sterility assurance, raw materials, single-use technology, and packaging, all within established quality systems.
• Design and oversee process validation, qualification, and monitoring strategies, implementing master validation plans for processes, equipment, and facilities in collaboration with Subject Matter Experts.
• Build and manage a multi-site organization that supports the product portfolio, ensuring efficient processes, knowledge exchange, and integration of lessons learned.
• Oversee resource allocation and make strategic "make vs. buy" decisions based on project priorities and technology strategies, adhering to CTO CGT governance processes.
• Drive innovation by integrating internal and external expertise, incorporating the latest technologies, and leading digital programs aligned with CTO CGT strategies.
• Ensure compliance with all relevant regulations (e.g., ISEC, GMP, HSE), and manage regulatory submissions, including the creation of source documents and dossier modules.