18588 - project manager car-t j&j.

• As Project Lead Operations you will be responsible to drive the projects from an operational perspective related start/scale-up of the facility (ramp-up program, MES program). In a challenging, fast-paced environment, you play a central role in the organization to drive change, in which you will have a direct impact on the CAR-T program.

  By collaborating with various other functions (quality assurance, quality control, health and safety, information technology, operations, planning, etc.) you will support the start-up and scale-up of the CAR-T process.

  You take ownership for your projects in the Manufacturing process and will handle all related requirements, including the following responsibilities:

  • Act as project manager for operational projects related to the ramp-up program.

  • Have a ‘boots on the ground mindset’ to make sure that the actions are driven to execution.

  • Support the lean design and implementation of Information Technology systems (SAP, MES, S/4, ...)

  • including future releases to continuously improve performance and compliance.

  • Provide Operational expertise in the Technical Operations discussions based upon a combination of intensive GMP knowledge of ATMP’s, knowledge in aseptic techniques and extensive process knowledge of cell and gene therapy products.

  • Immerse yourself in CAR-T processes, build up solid expertise, ensure timely development and implementation of a robust operational documentation framework, including operating procedures, work instructions, (electronic) batch records etc., and ensure adequate training of the organization.

  • Ensure end-to-end overview of the flow of all material required in your area, including process material, documents, waste, samples.

  • Identify risks and opportunities in relation to process, contamination, cross-contamination and mix-up control on the shop floor and drive follow up initiatives for improvement in close cooperation with operators, QA, QC and operations management.

  • Instil a mindset of high standards of safety and cGMP compliance, ensuring the reliability of your operations and readiness for audits or inspections at all times.

• Minimum 8 years of relevant work experience, preferably in aseptic manufacturing.

  Qualification & skills:

  • You have a Master’s Degree in a scientific or technical field (Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry …).

  • You are an experienced project manager.

  • You have a strong knowledge in aseptic manufacturing.

  • You embrace diversity, equity, and inclusion.

  • You have detailed knowledge of the shop floor manufacturing process.

  • You have a start-up/can-do mindset, and you proactively search for solutions. - You prioritize, and provide clear instructions to peers.

  • 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.

  • Your verbal and written communication skills enable you to influence without authority.

  • You work independently and successfully, prioritizing and managing multiple tasks simultaneously, and integrating cross-functional issues.

  • You are able to concisely summarize and present results.

  • Experience with team-based collaborations is a must.

  • Experience with equipment/systems commissioning/qualification/validation, IT systems, cell therapy (CAR-T) is an asset.

As a consultant, in addition to your gross salary, you will also receive a number of benefits, including

Lunch vouchers worth €7

Net expense allowance of €80 (untaxed!)

Hospitalisation insurance

Car + fuel card (subject to conditions) OR commuting allowance

32 Holidays

13th month

Group insurance

ECO vouchers

In addition, Randstad Professionals offers a range of training opportunities to help you develop your skills and, as a consultant, you will regularly be invited to fun Randstad events.

At Randstad Professionals, we have something for everyone: we work as consultants on short and long-term projects, as well as on permanent contracts and self-employed assignments.