Associate Director, Autologous Cell Therapy Process Development

Johnson & Johnson is currently seeking an Associate Director, Autologous Cell Therapy Process Development to join our API Cell and Gene Therapy Organization located in Spring House, PA or Raritan, NJ.

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 MedTech, 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. Learn more at  https://www.jnj.com/.

We are seeking an energetic and highly motivated candidate for the role of Associate Director, who possesses proven expertise in autologous cell therapy process development. The ideal candidate will be responsible for late-stage process development of autologous cell therapies, with a strong focus on process improvement, life-cycle management, and tech transfer. This role involves integrating new equipment/technologies, developing unit operations, and investigating root causes to facilitate transformative manufacturing processes for cGMP Manufacturing. The successful candidate will oversee the monitoring of Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs) using statistical analysis, ensuring the robustness and capability of manufacturing processes. They will also identify and implement process improvements to support the commercialization of cell therapy products. This position requires collaboration with a cross-functional team to support CMC development and commercial production.

Key Responsibilities

• Use own experience in cell therapy process development to guide autologous platform and process development efforts


• Collaborate with and participate in cross-functional teams to facilitate BLA enabling workstreams, BLA submission, commercial launching, and post-approval activities


• Identify, critically assess, and evaluate opportunities to improve manufacturing outcomes such as improving process robustness, manufacturing successful rate, product quality of final product, and reducing COGs


• 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 and at national conferences, if needed


• As a people leader manage and mentor to 3-4 scientists to support project activities


• Other duties, if needed