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Sr Director, Process Development


Overview

As Senior Director, you will lead Kite’s MSAT organization at the Amsterdam commercial cell therapy facility, driving strategy, governance, and performance in manufacturing support, tech transfer, lifecycle management, and automation. You’ll shape the site’s operating plan and budget while building a high-performing, inclusive team of leaders. You’ll own technical governance, risk decisions, investigations, and regulatory readiness to ensure compliant, reliable operations that impact patients. This role sits at the intersection of manufacturing, quality, and development, enabling lifecycle improvements and cross-site collaboration. You will advance a mission-driven culture focused on curing癌

Verantwoordelijkheden
  • Define and execute the site MSAT strategy, operating plan, budget, workforce model, governance, capabilities, and performance measures
  • 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 post-transfer performance
  • Govern the validation lifecycle and use process knowledge, statistics, digital capabilities, and data science to improve robustness, yield, and risk management
  • Set direction for MSAT laboratories and operational automation, ensuring validated systems and data integrity
  • Lead technical content and readiness for regulatory submissions and inspections
  • Represent site priorities in global forums and collaborate across functions to meet lifecycle, capacity, cost, and continuity aims
  • Sponsor cross-site initiatives that advance operational excellence and long-term site competitiveness
Belangrijkste vereisten
  • PhD/MS or BA/BS with significant experience in biopharmaceutical manufacturing, technology transfer or process development
  • Significant leadership experience in a commercial GMP environment with accountability for technical performance and delivery
  • Deep GMP knowledge and manufacturing operations experience, including cell culture, aseptic processing, single-use systems, and automation
  • Executive-level communication and influencing skills
  • Strong prioritization, investigation, and problem-solving abilities
  • Ability to lead managers and senior technical professionals
  • GMP for biopharmaceuticals
  • Technology transfer, process validation, comparability, and process control
  • Cell therapy and/or biologics manufacturing experience

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