Senior Scientist, Cell Therapy Process Development & Tech Transfer

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Scientist to join a growing team focused on cell therapy process development for the development of innovative treatments for cancer. The position is a key part of the growing API Cell and Gene Therapy Organization located in Spring House, PA site.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.  Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.

We are looking for an energetic and highly-motivated Senior Scientist candidate with demonstrated expertise in autologous cell therapy process development, with an emphasis on CAR-T modified immune effector cell products.  The successful candidate will focus on the development of the next generation of autologous cell therapies with an emphasis on their rapid implementation for clinical and in time commercial products, enabling the advancement of these breakthrough treatments for hematological and solid tumor malignancies.  S/he will be tasked with directly supporting technology transfer of autologous cell therapy processes to internal clinical manufacturing, as well as to contract manufacturers in support of pipeline programs.  The successful candidate will also directly interact with both new and existing partners to support the development, implementation and troubleshooting of end-to-end automation systems and approaches for autologous T-cell therapeutics. The successful candidate will work as part of a cross-functional team supporting pre-clinical and clinical programs, focused on CMC development. 

Primary responsibilities for this role include, but are not limited to:

• Support technology transfer of autologous T-cell derived cell therapies processes to internal and CDMO clinical manufacturing
• Leverage own experience in cell therapy process development to guide autologous platform and process development efforts focused on T-cell derived effector cells
• As a leader; mentor and train team members on technology transfer, manufacturing support and troubleshooting/investigations; including support for person in plant activities as required
• Drive successful technology transfer activities, writing protocols, reports, and performing and coordinating activities to support successful manufacturing with internal and external partners
• Directly support implementation and execution of automated end-to-end manufacturing processes, working directly with equipment vendors and internal resources to ensure successful outcomes. Expertise with existing and emerging systems in this space together with troubleshooting is required
• Collaborate with and participate in cross-functional teams to facilitate IND-enabling, clinical Phase I/II-enabling activities as well as BLA enabling workstreams
• Identify, critically assess and evaluate opportunities to improve manufacturing outcomes such as improving success rate, throughput, reducing cost, process time and product quality of the final drug product
• Communicate program progress and issues to management, to regulatory agencies as necessary, and at national conferences as appropriate
• Other duties, as necessary