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Mes program lead

Gand
Johnson & Johnson Innovative Medicine
80 000 € par an
Publiée le Publiée il y a 8 h
Description de l'offre

Job Information

* Job Function: Supply Chain Engineering
* Job Sub Function: Automation Engineering
* Job Category: Scientific/Technology
* Location: Gent, East Flanders, Belgium


Job Description

CAR‑T is an innovative therapy that leverages a patient’s own immune system to fight cancer. By genetically modifying a patient’s T‑cells 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 CAR‑T 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 CAR‑T manufacturing environment.

In this key role, you will manage all aspects of project governance—scope, schedule, budget, risks, and alignment across functions—for 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 life‑saving 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 required—the priority is strong project leadership, communication, and execution discipline in a fast‑paced, advanced therapy environment.


Responsibilities


Program & Project Management

* Lead the end‑to‑end delivery of MES‑related 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 cross‑functional 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 cross‑functional problem‑solving to address deviations, delays, or scope changes affecting MES deliverables.
* Quickly adapt plans, re‑prioritize activities, and coordinate required adjustments in response to evolving business needs.
* Drive a proactive, solution‑oriented mindset to maintain project momentum and minimize operational impact.


Strategic Contribution

* Support the scaling of CAR‑T 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 CAR‑T EMEA.


Qualifications


Education

* A master’s 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, fast‑paced, or technology‑driven 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 cross‑functional alignment.
* Excellent communication and organizational skills; ability to simplify complexity and maintain stakeholder engagement.
* Strong problem‑solving capabilities and ability to independently drive actions to completion.
* Proven ability to lead without direct authority, fostering collaboration and decision‑making across functions.
* Comfortable navigating ambiguity, adapting quickly to evolving priorities, and maintaining momentum in a dynamic environment.
* Proactive, solution‑oriented, 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.


Required Skills

* Strong project management and communication skills, with a proven track record of delivering complex programs under regulatory constraints.
* Ability to manage scope, schedule, budget, risks, and cross‑functional alignment effectively.
* Excellent stakeholder engagement and problem‑solving abilities.
* Experience navigating ambiguity and adapting quickly to shifting priorities.
* Proactive mindset to maintain momentum and deliver outcomes.
* English fluency is essential; Dutch knowledge is a plus.
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