Principal Scientist, Cell Therapy Process Development

We are seeking a Principal Scientist to work with the Cell Therapy teams at Regeneron Pharmaceuticals as we work towards deploying CAR-T cells to fight cancer. You will have high internal visibility and focus on supporting the research & development of robust and scalable manufacturing platforms for allogeneic T cell expansion and directed differentiation. You will have the opportunity to establish manufacturing platforms and guide product development through all stages of development to ensure project advancement. This role sites offsite in Florham Park, NJ

In this role a typical day may include:

• Independently design studies aimed at optimizing and improving expansion and manufacturability of candidate products based on the biology and the target.
• Design and execute experiments using approaches such as DOE or QBD, maintain detailed records of results, and present results to multi-disciplinary teams and leadership.
• Apply DOE/DQB for process characterization, establish process parameters, and contribute to CMC sections of regulatory filings.
• Develop cell isolation, enrichment, separation and formulation protocols and technologies/ platforms to support product development.
• Develop processes that integrate innovative approaches to increase the functional capability and yield of gd T cells.
• Relying on an in-depth CAR-T background, perform statistical analyses using product attribute data to assist, guide, and execute comparability studies.
• Develop and oversee tech transfer of protocols to CDMO.
• Collaborate with SME(s) at CDMOs to deliver timely and accurate technical solutions to resolve investigations and improve manufacturing performance and reliability.
• Present experimental outcomes, process analytics, and data trends to larger cross functional groups and leadership.

This role may be for you if you:

• Enjoy the challenge of developing and improving processes for CAR-T manufacture.
• Desire an opportunity to make key and highly visible contributions.
• Have a sound understanding in various approaches for CAR-T manufacture.
• Enjoy working in a matrix environment and guiding collaborations.

To be considered for this role, you must have a Ph.D. + 6 years in immunology or bioengineering discipline with relevant industry experience, including cell therapy process development. We need someone with extensive hands-on experience in cell culture (primary cells and cell lines), aseptic culture, as well as genetic modification of cells using transduction and/or transfection. Experience with gamma delta and other T cell lineages is needed. Experience in establishing cell therapy manufacturing processes and improving scalable upstream processes in the PD setting is required. Experience using wave rocker systems, benchtop bioreactors, Sepax, LOVO, and closed harvest systems will be needed. Familiarity with flow cytometry assays and other cell-based characterization assays (i.e. cytokine release and cytolytic assays) is a plus. Proven experience in the transfer of technologies/processes. Demonstrated capability to conduct/document complex manufacturing processes, familiarity with FDA guidance's, and an understanding of GMP GDP/quality is preferred.