Scientist​/Senior Scientist, Integrated Attribute Sciences - Allogeneic Cell Therapy

Scientist/Senior Scientist, Integrated Attribute Sciences - Allogeneic Cell Therapy

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Skills:



• Expertise in cellular and/or molecular immunology is required. Prior research with cell therapy products (i.e. autologous or allogeneic T/CAR T cells, HSC and/or iPSC) will be prioritized.

• Experience with analytical platforms for the characterization of T cell phenotype, differentiation, and function: i.e. cell-based immunoassays, cytokine/proteome analysis platforms, in vitro live imaging systems, conventional and spectral flow cytometry, metabolic profiling, CRISPR and gene editing, transcriptome and proteome profiling, etc.

• Experience with data analysis and visualization software (for example, Flowjo, OMIQ, JMP, EXCEL, etc.) and/or coding-based analysis (example: R, Python, etc.).

• Independence in experimental design, data analysis, interpretation, and presentation.

• Ability to work in a high-paced, cross-functional team environment, meet deadlines, & prioritize work on multiple projects.

The Cell Therapy Integrated Attribute Sciences (IAS) department is seeking a Scientist or Senior Scientist to support the development of the Allogeneic Cell Therapy pipeline programs. The goal of Cell Therapy is to revolutionize medicine by re-directing the body's immune cells to specifically target cancer cells. Allogeneic or "off-the-shelf” CAR T cells are generated from healthy donor-derived T cells rather than the patient's T cells and can be delivered to patients without manufacturing wait time.

The Attribute Sciences Team is responsible for developing and executing in-depth vector, starting materials, drug product characterization, and mechanism of action studies to support the development of gene-engineered allogeneic and autologous cell therapies. The primary focus of the Attribute Sciences Scientist/Senior Scientist role will be to collaborate with IAS team members to build in-depth allogeneic CAR T cell product and manufacturing process data and understanding with particular focus on exploratory/investigational studies to support:

The identification of drug product critical quality attributes (CQA) to inform the overall product control strategy for the manufacturing of high-quality, best-in-class allogeneic cell therapy products.

The generation of product quality target product profiles taking into account safety and efficacy of drug products.

Support process development studies and investigations by building and mining in-depth data packages and generating hypothesis-driven conclusions and proposed risk mitigation strategies.

Generate in-depth product characterization data packages for inclusion in regulatory submissions (with specific attention to Module 3 S.3.1. Elucidation of Structure) and to answer agencies' information requests.

Successful candidates will have a strong foundation in Immunology and human T cell biology and experience with the design, optimization, and implementation of a broad range of in vitro cell-based and/or molecular T cell characterization assays (i.e. cytotoxicity assays, proliferation, cytokine production assays, multi-color conventional and spectral flow cytometry, gene editing, transcriptome and proteome profiling, etc.). Prior research experience with T cells / CAR T cells (including cell therapy research, allogeneic hematopoietic stem cell transplantation, etc.)

will be prioritized.
This role involves a minimum of 50% laboratory-based work, is highly collaborative, and requires a strong ability to prioritize deliverables, independence, a demonstrated ability to support cross-functional teams, attention to detail, a healthy sense of urgency, and a passion for exploratory and investigational science.

Education:
Scientist Level: PhD and 0-3 years; MS and 8+ years; BS and 10+ years in Immunology, Cell Biology, Bioengineering, or relevant discipline.
Senior Scientist level:
PhD and 3+ years; MS and 10+ years; BS and 12+ years in Immunology, Cell Biology, Bioengineering, or relevant discipline.

Responsibilities:

• Work collaboratively with Integrated Attribute Sciences Team members to identify, prioritize and support immediate IAS team goals and deliverables requiring the…