What are the responsibilities and job description for the Scientist Cell Therapy position at Johnson & Johnson?
Janssen Research & Development, LLC is recruiting for a 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 in Spring House, 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 Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
We are looking for an energetic and highly motivated Scientist candidate with proven expertise in autologous cell therapy process development. The successful candidate will focus on the late-stage process development of autologous cell therapies with an emphasis on process improvement, life-cycle management, and tech transfer, enabling the advancement of these breakthrough treatments for hematological and solid tumor malignancies. S/he will be tasked with integration of new equipment/technologies, unit operation development and route cause investigation, resulting in transformative manufacturing processes with enabling COGs ranges for cGMP Manufacturing. The successful candidate will work as part of a cross-functional team supporting clinical programs and commercial production, focused on CMC development.
Key Responsibilities
- Use own experience in cell therapy process development to guide autologous platform and process development efforts
- Design and own the execution of phase-appropriate process development studies identifying process parameters and appropriate ranges to be assessed for optimal experimental design of the study
- 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
- Apply phase-appropriate process development strategies to identify process parameters and appropriate ranges using QbD principles as applied to cell therapy
- 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
- Other duties, if needed
