Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Scientist, CAR-T Cell Characterization PCR. The position will be located in Malvern, PA.
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 and Development, LLC develops treatments that improve the health and lifestyle of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders and reproductive medicine.
The Biotherapeutics Development - Analytical Development (BioTD - AD) group is seeking an energetic, highly motivated leader to characterize autologous CAR-T and next-generation, iPSC-based CAR-T/NK cell platforms for allogeneic cell therapies. In this role, the Senior Scientist will establish the technical strategies for PCR utilization within the expanding cell therapy space. The development of strategies for the characterization and GMP testing of our cell therapy products including but not limited to CAR-T, CAR-NK, autologous and allogeneic platforms. The individual would shape these strategies required for in depth process and product understanding providing technical and strategic leadership to the function and to the CMC teams. A successful candidate will be involved in the design, execution, and optimization of cutting-edge cell therapy platforms and will have the opportunity to engage in multi-functional teams. She/He will learn from and contribute to industry-leading drug discovery/development programs that has brought numerous quality therapeutics to patients and has made significant contributions to human health.
Develop characterization strategies and implements plans to understand the cellular biology with respect to RNA/DNA expression, integration, and control of impurities associated with cellular process/product development in both autologous and allogenic production processes.
Develop methods to understand cellular impurities such as residual host cell DNA, residual LV plasmid, and surrogate safety markers such as RCL (VSVG) to control
Create approaches for characterization of T-cells, NK cells, and iPSC in apheresis, in process samples, and final drug product.
Develop PCR (RT-PCR, QPCR, ddPCR, etc) methods to characterize manufacturing processes.
Engage and/or lead technical investigation strategy in support of product investigations with respect to clinical outcomes or adverse events driving to root cause.
Lead technical forums both internal and external to the company to share knowledge and approaches related to cellular characterization strategies as they relate to cell-based therapies (CAR-T, CAR-NK, etc).
Develop innovative approaches to challenging solutions
Identify/collaborate with partners in academia or industry to execute on innovation ideas or characterization approaches
Effectively communicate scientific data and results across technical teams, project teams, and to the health authority as needed.
Ph.D. in molecular biology, cell biology, immunology, biological science, or related discipline with >4 years of experience or a M.S. with >6 years of experience in an academic or industry setting with a focus on T cell biology, immunology, cellular characterization/function, DNA integration
Excellent oral and written communication skills
Excellent interpersonal skills with the ability to operate effectively in a dynamic work environment
Ability to work collaboratively in a complex, matrix environment
Experience in therapeutic cell therapy research and/or development group is preferred
Expertise with primary T-cell, pluripotent SC culture, viral and non-viral gene delivery methods and molecular characterization assays is preferred
Independently design, execute and troubleshoot experiments, analyze, report and present data
Must be detail-oriented, highly organized and able to manage multiple tasks, handle tight timelines and deliver quality data
Understanding of the connections between clinical, process/product development, and biological outcomes
Experience with the development and registration of cell therapies is a plus.
Awareness to GMP requirements.
Ability to make timely decisions and operate effectively in times of ambiguity
Strong analytical problem solving, planning and organizational skill
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Janssen Research & Development, LLC (6084)
Johnson & Johnson