Project Start-up Lead

☞ Panda International

View: 140

Update day: 17-11-2025

Location: Beerse Antwerp

Category: Planning / Projects IT - Software

Industry: Staffing Recruiting

Position: Mid-Senior level

Job type: Full-time

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Job content

We are looking for a Project Start-up Lead to support and ensure the operational readiness for clinical and commercial cell therapy production for a global leading biotech company in Beerse, Belgium. You will be part of the EMEA Cart-T department!

Tasks and Authorizations

Responsibilities

aseptic cleanrooms, sterilization, gowning, systems & equipment, facility design, scheduling, material/sample/personnel/waste streams … including but not limited to the following responsibilities

In the challenging and interesting CAR-T environment you will help to deliver a fully operational process by supporting in diverse operational workstreams, e.g.
  • Give operational input to develop the complete production process and the facilities, equipment and systems related to the process
  • Project-based collaboration with all supporting departments (QA, EHS, QC, IT, Supply …) and process development teams to support the successful transfer of the CAR-T process to GMP production facilities & the on-time delivery of clinical and commercial production
  • Set-up and maintain partnerships with supporting departments and the Legend Biotech organization to successfully transfer the operational process and meet compliance, quality and EHS&S standards
  • Support the design and the implementation of MAKE IT systems (MES, SAP, EMS, IDP, Vineti ...)
  • Support the timely delivery of operational documentation (SOP’s, WI’s, FORM’s, protocols …) and ensure a timely and qualitative roll-out of the training for the organization.
  • Support the design of the (electronic) batch records - Actively support inspections

In this way, you will contribute to a successful start-up of CAR-T in the EMEA region & you will obtain knowledge & expertise to grow to another function (e.g. Manufacturing Excellence, Quality, SC …) after the operational implementation.

Profile

Knowledge
  • Pharmaceutical regulations (cGMP, GTP, 21 CFR 210/211, ICH, Eudralex Vol 4, ATMP, ...)
  • Experience in project management
  • Experience in equipment/system qualification
  • Experience in process design
  • Start-up/can-do mentality, where you proactively search for solutions
  • Be able to cope with a rapid changing environment
  • See diversity as an asset
  • Can handle procedures/guidelines which require strict execution

Education
  • Master’s degree in a scientific or technical field (e.g. Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry)

Languages
  • English
  • Dutch

Systems
  • Trackwise
  • SAP
  • MES/EBR systems

Practicalities
  • Location: Beerse, Belgium
  • Duration: 1 year contract
  • Full – time: 40 hours
  • On-site 4 days a week
  • Start Date: ASAP

Interested?

Send your CV to Khanyi Mabena at k.mabena@panda-int.com or contact her on +31 (0)20 2044 502.
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Deadline: 01-01-2026

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