Key Skills

Job Description

The CoE Manager leads the Centre of Expertise (CoE) within the client's manufacturing facility in Sassenheim. This team serves as the technical backbone of the manufacturing organization, providing expert support to Operations and ensuring that manufacturing processes, materials, equipment, and digital systems are executed efficiently, safely, and in compliance with GMP regulations. As a people leader, the CoE Manager is responsible for managing a team of manufacturing specialists and driving technical excellence across the plant. The role acts as a key interface between Operations and cross-functional stakeholders, translating process knowledge into practical manufacturing solutions while supporting continuous improvement, innovation, and commercial production goals. The position combines strong leadership responsibilities with deep technical expertise in GMP manufacturing, process support, equipment technologies, and operational excellence. Responsibilities Leadership & Team Management Lead, develop, and motivate a team of manufacturing and technical specialists. Allocate resources effectively to deliver departmental objectives within timelines and budget. Foster a culture of accountability, continuous learning, innovation, and operational excellence. Coach team members and support capability development. Technical & Operational Support Provide expert technical guidance to manufacturing operations. Act as the escalation point for complex process, equipment, and technical issues. Ensure the successful translation of manufacturing processes into reliable shop-floor execution. Support implementation of new products, technologies, and process improvements. Continuous Improvement & Projects Lead technical changes and small-to-medium complexity improvement projects involving equipment, single-use systems, and manufacturing processes. Drive initiatives focused on quality enhancement, capacity expansion, cycle time reduction, cost improvement, and process optimization. Apply Lean manufacturing principles and methodologies to improve operational performance. Promote innovative solutions to business and manufacturing challenges. Equipment & Materials Management Oversee technical requirements for manufacturing equipment and disposable technologies. Monitor maintenance activities and equipment performance. Partner with Engineering and Maintenance teams to address recurring equipment issues and evaluate replacement strategies. Support qualification and implementation of new materials and raw materials. Compliance & Cross-Functional Collaboration Review and approve technical documentation to ensure compliance with GMP and internal standards. Collaborate closely with Operations, Quality Assurance, Quality Control, MSAT, Engineering, IT, and other functions. Ensure adherence to EHSS, GMP, Annex 1, and company compliance requirements. Support inspection readiness and regulatory compliance activities. Requirements Bachelor's or Master's degree in Engineering, Process Engineering, Mechanical Engineering, Electrical Engineering, Automation Engineering, Chemical Engineering, Biotechnology, Life Sciences or a related technical/scientific discipline 10+ years of experience within a GMP-regulated pharmaceutical, biologics, cell therapy, gene therapy, vaccine, or biotechnology manufacturing environment. 6-8+ years of people leadership experience, including managing technical teams, supervisors, or departments. Demonstrated success leading Lean or continuous improvement initiatives. Experience supporting manufacturing operations and technical process troubleshooting. Strong understanding of GMP regulations and pharmaceutical manufacturing processes. Experience managing cross-functional stakeholders in a highly regulated production environment. GMP and Annex 1 compliance. Pharmaceutical or biologics manufacturing processes. Manufacturing equipment and single-use technologies. Process improvement and operational excellence methodologies. EHSS requirements and regulatory standards. Data-driven decision making and performance management. Strong people leadership and coaching skills. Ability to influence and collaborate across functions. Innovation mindset with a focus on continuous improvement. Agile decision-making and problem-solving capabilities. Customer-focused approach with excellent communication skills. Resilience and ability to perform in a fast-paced manufacturing environment. Strong ownership, accountability, and execution focus.

Core Responsibilities

Lead and develop the manufacturing Centre of Expertise team, providing technical support to operations and ensuring reliable, safe, and compliant manufacturing processes. Drive equipment and process improvements, manage technical projects, oversee equipment and materials requirements, and collaborate across functions to support production and regulatory readiness.

Requirements

Requires a bachelor's or master's degree in a relevant engineering, life sciences, biotechnology, or related technical discipline, along with 10+ years of experience in a GMP-regulated manufacturing environment. Candidates should have 6–8+ years of people leadership experience, strong GMP and pharmaceutical manufacturing knowledge, and a record of leading continuous improvement and supporting technical operations.