Principal Cell Therapy Engineer

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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 Med Tech, 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.

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Job Function: Supply Chain Engineering

Job Sub Function: Process Engineering

Job Category: Scientific/Technology

All Job Posting Locations: Horsham, Pennsylvania, United States;
Raritan, New Jersey, United States;
Spring House, Pennsylvania, United States

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science‑based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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We are searching for the best talent for a Principal – Cell Therapy Engineer to join our team!

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 is working to develop, manufacture, and commercialize products in the CAR‑T space.

The Cell Therapy Senior Principal Engineer is part of the Operations workstream and closely connected to the Quality and Tech Transfer workstream. You will act as a decision maker in the Operations workstream, with responsibilities to shape the manufacturability of the R&D process, collaborate in the development and own set‑up of supply chain technology and processes for a new facility design.

By collaborating with various other functions (MSAT, R&D, Engineering, quality assurance, quality control, health and safety, information technology, operations, planning, etc.) you will support the successful transfer of the CAR‑T process, the timely start of clinical and commercial manufacturing and further improvement and scale‑up of the process. The overall goal is creation of a compliant, reliable, cost competitive commercialized facility.

• Provide Operational expertise in the Technical Operations discussions based upon a combination of GMP knowledge of facility design, knowledge in aseptic techniques and process knowledge in development of technology either in ATMPs or equivalent industry that is transferable to cell and gene therapy products.
• Provide Operational expertise in the R&D process to support reliable, repeatable, GMP manufacturability of the process in development.
• Provide Operational guidance to the facility resource model. Leverage the model to shape the product development and operational processes to deliver solutions for cost competitiveness.
• Lead the development of user requirements for new technology and processes, translate the requirements into operational performance efficiencies and impacts.
• Ensure completion of user acceptance testing to deliver user requirements and performance efficiencies.
• Find opportunities for improvement in your area and lead their development and implementation.
• Immerse yourself in CAR‑T processes, build up proven 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…