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Job Description:

Are you inspired to make a big difference in the life expectancy of our patients?

CAR-T is an innovative treatment, which uses the power of the patient’s own immune system. A patient’s T-cells are genetically modified to eliminate cancer cells. This ground-breaking technology provides hopeful prospects to patients where other therapies have failed or fail to provide adequate results.

Janssen Biotech, Inc. entered into a global collaboration agreement with Legend Biotech to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.

To support the CAR-T program in EMEA, Janssen is building two CAR-T manufacturing centers in the Ghent area (Belgium).

The Ramp Up Lead is part of the Operations team and closely connected to the Quality and Tech Transfer workstreams. This position will be based at our new manufacturing facility (Tech Lane) in the leading Biotechnology Hub of Ghent, Belgium. You will have the unique opportunity to gain deep knowledge & expertise in a highly innovative and future oriented environment with the ability to profoundly impact the trajectory of health of our patients.

Roles & responsibilities:

The Ramp Up Lead role is accountable for the seamless scale-up of CAR-T production at the Techlane Manufacturing Site while safeguarding the production system, health and safety, quality, compliance, and regulatory standards. You will be leading this ramp up project after commercial go-live in close collaboration with the Legend partner and you' ll serve as the single point of contact (SPOC) for J& J operations during the various ramp-up related meetings and coordinate activities across multiple departments.

In a challenging, fast-paced environment, you play a central role in the organization, in which you will have a direct impact on the CAR-T program by executing capacity ramps with a focus on quality and deliver slot commitments to patients.

You take ownership for the ramp-up and will handle all related requirements, including the following responsibilities.

• (Co)lead detailed ramp-up plans after commercial go-live, including resource allocation, risk management, and contingency planning, ensuring adherence to project timelines, budgets, and quality standards.

• Identify and address potential bottlenecks or challenges during the ramp-up phase (ao via stress testing). Develop mitigation strategies to ensure project success in collaboration with cross-functional teams including operations (cell processing engineers), production, health and safety, quality, regulatory and engineering.

• Identify and address potential bottlenecks or challenges during the ramp-up phase (ao via stress testing). Develop mitigation strategies to ensure project success in collaboration with cross-functional teams including operations (cell processing engineers), production, health and safety, quality, regulatory and engineering.

• Ensure that all quality and compliance parameters are within target (EM trending, NC closure, NC/batch) throughout the entire ramp-up. Define these parameters in advance within a capacity execution protocol and follow up via the stage gate process.

• Ensure that the different (material and waste) flows are aligned with the various biocontamination, cross-contamination risk assessments, and mix-up prevention strategies.

• Keep track of equipment needs in cooperation with the MAM organization in line with the ramp-up phase. Oversee the seamless installation, commissioning, and validation of new equipment to support the ramp-up activities.

• Add a regular report to operations management on achievements, upcoming actions, and key risks to ensure transparency and proactive management.

• Add a regular report to operations management on achievements, upcoming actions, and key risks to ensure transparency and proactive management.

• Ensure adherence to GMP, GxP, and regulatory guidelines throughout the ramp-up phase.

• Furthermore, a large portion of your time will be focused on developing detailed knowledge of the CAR-T production system:

Experience

• 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 have experience in project management.

• You place our patients at the center of everything you do.

• You embrace diversity, equity, and inclusion.

• You have strong knowledge of aseptic manufacturing.

• 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.