Senior Principal Scientist, Manufacturing Science and Technology (MSAT)

Janssen Pharmaceutical Companies of Johnson & Johnson is recruiting for a Senior Principal Scientist, Manufacturing Science and Technology (MSAT), preferably located in Raritan, NJ or Springhouse, PA.

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 Senior Principal Scientist we are looking for is responsible for leading the coordination of tech transfer activities and technical services across the platform of the Advanced Therapies. In this role you are charged with running New Product Introductions for life saving drugs and/or drugs with high unmet medical need, such as cell and gene therapy products. You will also be responsible for Life-Cycle Management projects that will drive reliability, innovation and sustainability in our processes and plants, both internally and externally. In this role, you will partner with R&D, Quality, and Regulatory to ensure processes meet the needs of today and tomorrow.

The Senior Principal Scientist can work in close collaboration with other roles and must have strong communication skills to influence other functions/levels outside of own group. In this role you will effectively lead global and cross organizational teams to generally attain desired results for all parties. Strong knowledge in cell and gene manufacturing processes is a must. Hands-on experience in both R&D and Manufacturing Operation is highly desirable. 

Do you have strong leadership and project management skills, and do you have a passion for biological processes and innovation? If so, then you may be the person we are looking for!

Key Responsibilities:

• Technical and manufacturing integration of new and re-developed processes from R&D into the supply chain (cell/gene therapy products, vaccines, or any other advanced therapy products).
• 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.
• Leading projects that will enhance manufacturing output. Your efforts will have a direct impact on patient supply!
• Ensuring product supply from the manufacturing site for which manufacturing performance, cost, and robustness requirements are met.
• 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.)