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JOB SUMMARY

CAR-T is an innovative treatment, which uses the power of the patient’s own immune system. A patient’s T-cells are genetically modified to eliminate cancer cells. This ground-breaking technology provides hopeful prospects to patients where other therapies have failed or fail to provide adequate results.

Are you ready to play a crucial role in transforming cell therapy manufacturing? Join our innovative CAR-T team in Ghent as an MES Lead, where you'll support clinical and commercial CAR-T production and help accelerate capacity ramp-up. This is a unique opportunity to deepen your expertise in a cutting-edge, future-proof environment while making a meaningful impact on patients' lives worldwide.

As MES Lead your main responsibilities include:

• Lead the cross-functional MES Core team including workstream managers and functional core team members (e.g. QA, Operations, MSAT, IT, etc.) serving as end-to-end decision maker in collaboration with business partners.
• Manage the MES department, supervising 10 to 25 MES engineers and contracted resources. Responsible for an operational budget of ~$2M to ~$3M and a capital expenditure of ~$10M.
• Develop and safeguard innovative MES solutions for both clinical and commercial operations, ensuring they align with budget, timelines & scope.
• Driving resolution of deviations affecting scope, schedule and/or budget, whether internal (e.g. MES delays) or external (e.g. additional scope from HA inspections), together with MES Core team members to prevent impact on site objectives like launch timelines and capacity ramp-up.
  • Develop and maintain governance structures to connect and communicate effectively with extended teams across departments, including up-to-date reporting to site leadership, as well as managing communication to internal stakeholders.
• Coordinate with project teams to build & integrate MES deliverables with key CAR-T projects (e.g. D10 Closure, TL Phase 2) to ensure alignment on project budgets and schedules.
• Promote a collaborative culture by fostering strong partnerships across internal and external stakeholders and maintaining a positive, proactive, solution-oriented mindset.

QUALIFICATIONS

Education:

• A master’s degree in Engineering, Business, Supply chain or related field is required

Experience and Expertise:

• 6 + years of relevant industry work experience
• Proven experience in operations or supply chain
• Strong leadership skills with extensive experience managing cross-functional teams.
• Excellent communication & influencing skills
• Ability to zoom out for strategic conversations & deep dive into details when needed
• You excel in a fast-paced environment and are energized by solving complex issues as part of a team.
• You thrive in a rapidly changing environment and lead as a change agent to promote flexibility, creativity, and accountability while at the same time handling procedures/ guidelines which require strict execution.
• You work independently and successfully, prioritizing and managing multiple tasks simultaneously, and integrating cross-functional issues.
• Ability to influence without direct authority.
• Able to lead cross functional conversations with all levels of the organization
• Ability to build strong collaborative teams and relationships
• Positive start-up/can-do mindset when dealing with challenges, and you proactively search for solutions.
• You are fluent in English, Dutch proficiency is considered an asset
  

Preferred:

• Experience with cell therapy operations
• Experience with aseptic manufacturing

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