MSAT Principal scientist Technical Launch Integrator DP Advanced Therapies

Johnson and Johnson is recruiting for a Senior or Principal Scientist, Technical Launch Integrator , preferably located Leiden, the Netherlands. Other locations could be considered.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies.

The Technical Launch Integrator we are looking for is responsible for leading and coordinating the tech transfer activities and providing technical services across the Advanced Therapies platform.

As TLI you are charged with New Product Introductions for life saving drugs and/or drugs with high unmet medical need. This can be vaccines , but also cell and gene therapy or other products. Additional to the TLI role, this position may also support marketed products as Technical Owner. The Technical Owner is responsible for Life-Cycle Management projects that drive reliability, innovation and sustainability in our processes and plants, both internally and externally.

You will partner with R&D, Quality, and Regulatory to ensure processes meet the needs of today and tomorrow. The Technical Launch Integrator must be able to shape, work in close collaboration with other functions, and must have strong communication skills to influence other functions/levels. You will effectively lead global and cross organizational teams to generally attain desired results for all parties. Strong knowledge in vaccines and/or cell and gene manufacturing is a must. Hands-on experience in both R&D and Manufacturing Operation is highly desirable.

The initial focus for the position is on Drug Product, but the expectation is the TLI will in future (following training and coaching) also be able to handle Drug Substance (DS) programs.

Key Responsibilities:

• Technical and manufacturing integration of new and re-developed processes from R&D into the supply chain, and/or for site-to-site Tech Transfers, for cell/gene therapy products, vaccines, or any other advanced therapy products, covering raw materials and disposables sourcing, production process, packaging and transport of (bulk) DP, as well as supporting the VCL for launch activities.
• Leading the manufacturing site Tech Transfer project team and being the manufacturing site representative on the R&D team and the Value Chain Team. Ensuring site readiness and launch readiness.
• Single point of contact for Janssen Advanced Therapies Supply Chain (ATSC) plant readiness and execution from technical transfer into commercial production (e.g., tech transfer implementation, site-based documentation, planning, risk management, budgeting) and launch support.
• Ensuring product supply from the manufacturing site for which manufacturing performance, cost, and robustness requirements are met.
• Providing required manufacturing technical support during execution, integration of JSC technical expertise (e.g., platforms, engineering, SME’s) into project execution.
• Representing Supply Chain in all Design-for-Manufacturability activities during the development process.
• Identifying and implementing opportunities for innovation and deploying new technologies, focus on active decrease in COGs, partnering with R&D and JSC groups to develop and implement strategies to improve the fit for plant and commercialization of new products into the supply chain.
• Contribution, review and approval of the product technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc.)