MES Program Lead

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Job Description:

CART is an innovative therapy that leverages a patients own immune system to fight cancer. By genetically modifying a patients Tcells to recognize and destroy cancer cells this transformative technology offers new hope to patients who have exhausted other treatment options.

Are you ready to drive the next wave of digital readiness within CART manufacturing

Join our dynamic team within the CAR-T organization in Ghent as New Programs MES Lead where you will lead the delivery of MES-related programs supporting capacity expansion for the CAR-T EMEA manufacturing sites. These programs are essential to ensure that our MES solution stays aligned with operational needs regulatory requirements and the rapid growth of CART manufacturing envrionment.

In this key role you will manage all aspects of project governancescope schedule budget risks and alignment across functionsfor new programs impacting the MES landscape in Ghent. You will act as the responsible person who ensures that MES changes and new electronic batch records are delivered effectively on time and in full support of our mission: bringing our lifesaving product to patients.

You will report directly to the MES Manager and will work closely with MES Technical Experts who will provide technical expertise. While MES expertise is beneficial deep system knowledge is not requiredthe priority is strong project leadership communication and execution discipline in a fastpaced advanced therapy environment.

As New Programs MES Lead your main responsibilities include:
Program & Project Management

• Lead the endtoend delivery of MESrelated programs including significant process updates (batch records changes) and the design of new batch records.
• Develop align and maintain a comprehensive project plan covering scope schedule budget and resource needs.
• Drive project governance ensuring traceability of decisions clear ownership and timely escalation of risks.

Cross-Functional Coordination & Communication

• Act as the central communication hub between Operations QA engineering and vendor partners.
• Facilitate crossfunctional alignment on program requirements milestones and constraints.
• Ensure structured communication across the organization including progress updates issue reporting and milestone tracking.

Issue Resolution & Adaptability

• Lead crossfunctional problemsolving to address deviations delays or scope changes affecting MES deliverables.
• Quickly adapt plans reprioritize activities and coordinate required adjustments in response to evolving business needs.
• Drive a proactive solutionoriented mindset to maintain project momentum and minimize operational impact.

Strategic Contribution

• Support the scaling of CART manufacturing by ensuring MES programs are delivered to enable capacity growth.
• Identify improvement opportunities to strengthen project delivery frameworks and MES change management processes.
• Act as an ambassador for digital excellence within CART EMEA.
  

QUALIFICATIONS

Education:

A masters degree in Engineering Business Life Sciences Supply Chain Computer Science or a related field is required.

Experience and Expertise:

• 6 years of relevant industry experience in manufacturing digital systems operations or project management.
• Proven experience managing projects in a regulated fastpaced or technologydriven environment.
• Prior exposure to MES advanced therapies electronic batch records or digital manufacturing systems is highly preferred.
• Strong project management skills with ability to manage scope schedule budget risks and crossfunctional alignment.
• Excellent communication and organizational skills; ability to simplify complexity and maintain stakeholder engagement.
• Strong problemsolving capabilities and ability to independently drive actions to completion.
• Proven ability to lead without direct authority fostering collaboration and decisionmaking across functions.
• Comfortable navigating ambiguity adapting quickly to evolving priorities and maintaining momentum in a dynamic environment.
• Proactive solutionoriented and able to bring clarity and structure in complex situations.
• Fluent in spoken and written English; knowledge of Dutch is a plus but not required
• Experience in cell therapy biologics sterile operations or other GxP manufacturing environments.
• Project management certification (PMP Prince2 Agile) is an asset.
• Familiarity with validated/regulated system lifecycle management

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