Senior director msat Vacatures

Over de vacature

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

Over de vacature

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

Over de vacature

Overview

In this role you will lead Teva's external manufacturing network to ensure reliable patient supply, product quality, and compliant, cost-effective operations. You'll steer a cross-functional virtual plant team and serve as the primary operations interface with partner sites. You'll drive governance, risk mitigation, and continuous improvement across manufacturing, quality, regulatory and supply chain. This is a strategic leadership position with impact on enterprise-critical products and long-term supplier value. You'll work in a high-performance, collaborative culture that values growth and innovation.

Arbeidsvoorwaarden / Benefits

• generous annual leave
• reward plans
• flexible working schedules
• tailored health support
• Twist career development platform
• internal growth opportunities

Verantwoordelijkheden

• Coordinate end-to-end operations with external partners to secure patient supply, tech transfer, validation, regulatory approvals, and lifecycle changes
• Establish governance, metrics and management reviews across internal and external stakeholders
• Communicate priorities and performance outcomes to align cross-functional teams
• Identify and mitigate supplier and business risks with proactive contingency plans
• Resolve manufacturing delivery issues and partner-related challenges
• Collaborate with MSAT for process capability, control strategy, ROB, and COGS improvement
• Ensure ongoing cGMP compliance, inspection readiness, and quality governance with QA/Regulatory
• Sponsor investigations and cross-site technical improvements; manage manufacturing readiness
• Promote safety, health and environmental policy adherence in operations
• Drive Lean, digital manufacturing and standardization across external partners
• Build executive-level relationships with suppliers to enhance reliability and value creation
• Coach and develop cross-functional team members; manage projects and major initiatives
• Support capacity, capital planning, and major external manufacturing projects for compliance and growth
• Lead due diligence input on capacity and supplier network decisions
• Contribute to supplier strategy and contract development to ensure supply continuity
• Collaborate in License and Supply Agreement development to embed external manufacturing oversight

Belangrijkste vereisten

• 15+ years in biologics manufacturing/related roles

• 10+ years leadership in biologics manufacturing and external CDMO management

• Bachelor in Engineering (Master/MBA preferred)

• Strong knowledge of cGMP, tech transfer, process validation, quality systems, product lifecycle

• Experience with regulatory filings, inspections, and launches

• Financial acumen including COGS, S&OP/IBP, capital investment

• Proven cross-functional leadership and stakeholder influence across global matrix organizations

• Strong change management and continuous improvement track record

• Willingness to travel 25%

• collaboration

• influence and relationship-building

• communication

• cGMP

• technology transfer

• process validation

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

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