Sr Director, Process Development

Over de vacature

Overview

In this role you drive the MSAT strategy for Kite's Amsterdam commercial cell therapy facility, leading a high-performing team of managers and senior technical leaders. You ensure robust, compliant manufacturing, technology transfer, and lifecycle activities in a GMP environment, while partnering across functions to deliver reliable patient-facing operations. You shape governance, risk-based decisions, and regulatory readiness, enabling scalable, efficient production. You will influence site and network priorities and advance operational excellence in cell therapy manufacturing.

Verantwoordelijkheden

• Define and execute the site MSAT strategy, operating plan, budget, workforce model, governance, capabilities, and performance metrics
• Build and develop an inclusive, high-performing organization of managers and senior technical leaders
• Lead technical governance, escalation, and risk-based decisions for manufacturing support, process performance, validation, and high-impact issues
• Oversee shop-floor support, investigations, root-cause analysis, CAPAs, laboratory studies, and process improvements
• Lead technology transfer and lifecycle management including facility fit, risk assessment, control strategy, comparability, qualification, PPQ readiness, training, and sustained post-transfer performance
• Govern the validation lifecycle using process knowledge, statistics, digital capabilities, and data science to improve robustness, yield, cycle time, and proactive risk management
• Set direction for MSAT laboratories and operational automation, ensuring validated systems, data integrity, and manufacturing integration
• Lead technical content and readiness for regulatory submissions, health-authority inquiries, inspections, and commitments
• Represent site priorities in global forums and collaborate across Manufacturing, Quality, Supply Chain, Facilities & Engineering, Product Development, Regulatory Affairs, and global MSAT
• Sponsor cross-site initiatives that advance operational excellence, technology modernization, and long-term site and network competitiveness

Belangrijkste vereisten

• PhD/MS in relevant Science/Engineering with biopharmaceutical manufacturing or technology transfer experience OR BA/BS with relevant experience OR High School Diploma with significant experience in biopharmaceutical manufacturing

• Significant leadership experience in a commercial GMP environment with accountability for technical performance and delivery through managers and senior professionals

• Executive-level communication and influencing skills

• Strong collaboration across cross-functional teams

• Problem-solving mindset with ability to prioritize and drive results

• Deep GMP knowledge and experience in cell therapy, biologics, aseptic processing, single-use systems, and automation

• Technology transfer, process validation, comparability, and control strategy

• Validation lifecycle management, data science, statistics, and digital capabilities

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