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Principle Scientist, Cell Therapy Flow Characterization Lead , Cell and Gene Therapy, Analytical Development
Company: Johnson & Johnson
Location: Malvern, PA
Employment Type: Full Time
Date Posted: 09/04/2021
Expire Date: 12/08/2021
Job Categories: Biotechnology and Pharmaceutical, Healthcare, Other, Manufacturing and Production, Science, Quality Control, Research & Development, Medical
Job Description
Principle Scientist, Cell Therapy Flow Characterization Lead , Cell and Gene Therapy, Analytical Development

Principle Scientist, Cell Therapy Flow Characterization Lead – Cell and Gene Therapy - Analytical Development

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 Cell and Gene Therapy Group - Analytical Development (CGTG - 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 Principal Scientist will establish the technical strategies for flow cytometry 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.


Primary Responsibilities:

  • Develop characterization strategies and implements plans to understand the cellular biology with respect to growth/expansion of cellular subtypes during process/product development in both autologous and allogenic production processes.
  • Develop methods to monitor cellular immunophenotypes engaged in selection, activation, transduction, expansion/exhaustion and cryopreservation
  • Develop methods to monitor cytokine secretion using technologies such as Luminex, isoplex, ELISAs, etc.
  • Develop methods to understand cellular impurities and impacts of cellular expansion, formulations, and cryopreservation
  • Create approaches for phenotypic or functional characterization of T-cells, NK cells, and iPSC in apheresis, in process samples, and final drug product.
  • Develop flow-based 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.



Experience Required:

  • Ph.D. in cell biology, immunology, biological science, or related discipline with 8 years of experience or a M.S. with 10 years of experience in an academic or industry setting with a focus on T cell biology or cellular characterization/function
  • 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 Preferred:

  • Minimum of 2 yrs working in therapeutic cell therapy research and/or development group
  • Expertise with primary T-cell, pluripotent SC culture, viral and non-viral gene delivery methods and cellular based assays is preferred
  • Experience independently designing, executing and troubleshooting experiments, analyze, report and presentation of 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 skills
  • People leadership experience, working in a matrix team or direct line setting, is a plus

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.


Primary Location
United States-Pennsylvania-Malvern-200 Great Valley Parkway
Janssen Research & Development, LLC (6084)
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