Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Principal Scientist, Autologous CAR-T Cell Platform Analytical Characterization to be located in Malvern, PA.
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The Biotherapeutics Development-Analytical Development (BioTD-AD) group is seeking an upbeat, highly motivated leader to characterize next-generation CAR-T cell platforms for autologous cell therapies. The Principal Scientist will establish the technical strategies for deep T cell characterization, single cell analysis, and leading the complex manufacture investigation for oncology and other indications.
The Principal Scientist will shape the strategies required for in depth process and product understanding and provide technical and strategic leadership to the function and to the Chemistry Manufacturing Control (CMC) teams. The individual will have a strong foundation in human T cell and stem cell biology. Experience with the design, execution and optimization of a broad range of in vitro cell based characterization assays, and will have the opportunity to engage in multi-functional teams. They 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.
- Lead the overall scientific, technical and operational efforts with regards to product characterization methods development including single cell analysis, lead new assay conceptualization & selection.
- Lead technical investigation strategies in support of product investigations with respect OOS (out of specification), or to clinical outcomes or adverse events driving to root cause.
- Lead on the digital data integration including working with data science team to understand all of the manufacturing/clinical data
- Promote positive relationships with API and Drug Product Development functional leaders, data sciences, Janssen Supply Chain leaders, Quality Assurance, and Discovery.
- Direct 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 implement innovation ideas or characterization approaches.
- Effectively communicate scientific data and results across technical teams, project teams, and to the health authority as needed.
- PhD in Cell Biology, Immunology, Biological Science or a related field with 7 years of experience or a M.S. degree with 10 years of experience in an academic or industry setting with a focus on T cell biology or cellular characterization/function is required.
Experience and Skills:
- Experience with in vitro technologies to assess lymphocyte functionality including but not limited to single cell analysis, multi-parameter flow cytometry, MSD, Luminiex, xCELLigence and IncuCyte-based assays, for phenotypic characterization of T/NK cells, T/NK cell activation, cytotoxicity and proliferation assays is required.
- Extensive knowledge of the connections between clinical, process/product development, and biological outcomes is required.
- Ability to work collaboratively in a complex, environment is required.
- Excellent oral and written communication skills are required.
- Ability to independently design, implement and troubleshoot experiments, analyze reports and present data is required.
- Must be detailed, highly organized, able to prioritize multiple tasks with tight timelines and deliver quality data.
- Experience with the development and registration of cell therapies is a plus.
- Awareness of GMP requirements is desired.
- Ability to make timely decisions and operate effectively in times of ambiguity is highly preferred.
- Strong analytical problem solving, planning and organizational skills are desired.
- People leadership experience, working in a team or direct line setting, is highly desired.
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.
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