Senior Scientist Cell Therapy Process Development

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 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.

Janssen Biotherapeutics Development & Supply is seeking an energetic and highly motivated individual with proven expertise in CAR-T process development to join our Cell Therapy Process Development team as a Senior Scientist. In this role, they will focus on process development, characterization, and validation activities, enabling the advancement of these breakthrough treatments for hematological and solid tumor malignancies. They will work as part of cross-functional teams supporting pre-clinical, clinical, and commercial programs, focused on autologous processes.

Responsibilities of the Senior Scientist may include, but are not limited to, the following:

Key Responsibilities:

• Use own experience in cell therapy process development to guide CAR-T autologous platform and process development efforts
• Design and lead the execution of phase-appropriate process development studies identifying process parameters and appropriate ranges to be assessed for optimal experimental design of the study
• As a group lead, mentor and train team members on experimental procedures and cultivate their professional development
• Proactively mitigate potential conflicts and rapidly resolve communication problems with internal partners, cross-functional teams and third-party collaborators
• 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
• Drive successful technology transfer activities, writing protocols, reports, and performing and coordinating activities to support successful manufacturing with internal and external partners
• Communicate program progress and issues to management, to regulatory agencies as necessary, and at national conferences as appropriate
• Cultivate a working environment that encourages the company's commitment to equal employment opportunity and the value of a diverse work force