project start-up lead.

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

• 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
• Support setting up/providing input to Change Controls necessary for the preparation of the facilities
• Performing according to the cGMP, quality, compliance and EHS&S standards

Interested in this vacancy? Send your mail and cover letter to sam.goetschalckx@professionals.randstad.be or call +32 2 472 73 61.

Required 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

As an answer to your high performance & flexibility, Randstad Professionals offers you an interesting salary package, with some interesting extras like:

• Meal vouchers of €7
• Net representation cost of €80
• Hospitalization insurance
• Car + unlimited fuel card OR home-work compensation
• 32 holidays
• End-of-year bonus
• Pension plan
• ECO vouchers
• Opportunities to follow trainings
• We offer permanent, project and freelance contracts

And on top of this you'll improve your skills and become an even bigger expert!