Job Specifications
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function
Technology Product & Platform Management
Job Sub Function
Technology Operations Support
Job Category
People Leader
All Job Posting Locations:
Gent, East Flanders, Belgium
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 & Sk
About the Company
At Johnson & Johnson Innovative Medicine, we innovate with purpose, to lead where medicine is going. The experiences of patients around the world inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science with compassion, we confidently address the most complex diseases of our time and develop the potential medicines of tomorrow. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients ev...
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