Scientist/Senior Scientist, Integrated Attribute Sciences - Allogeneic Cell Therapy
Top 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 application of in-depth drug product and starting materials characterization technologies and platforms for execution.
• Design, optimize and execute in-depth characterization experiments of cell therapy starting materials and drug products to answer high-priority targeted questions (such as investigation of product mechanisms of action MoA, responses to agency's information requests, manufacturing investigations, etc.).
• Perform and manage characterization method and instrument troubleshooting.
• Generate in-depth characterization data packages and conclusions of pipeline allogeneic starting material and CAR T cell products to enable immediate IAS team deliverables leveraging cutting-edge phenotypic, functional, metabolic, gene expression profiling tools and platforms, etc.
• Collaborate with members of the Attribute Sciences Team to identify, prioritize, and develop Client/next generation in Analytical Platforms and Technologies to interrogate cell therapy product function and MoA.
• Present experimental findings and project updates at cross-functional team meetings and to Client leadership.
• Serve as T cell biology subject matter expert in multidisciplinary team settings, that includes non-clinical, clinical, regulatory, and CMC functions.
• Author, review, and approve technical documents, including methods, protocols, reports, and SOPs.
Qualifications:
• Expertise in cellular and/or molecular immunology. Prior experience with cell therapy products (i.e. autologous or allogeneic T/CAR T cells, NK cells, HSC and/or iPSC) will be prioritized.
• Experience with routine and next-generation 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 (Flowjo, OMIQ, JMP, EXCEL, etc.) and/or coding-based analysis (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.
• Attention to detail and excellent interpersonal, written and verbal communication skills.
Preferred Qualifications:
• Experience with big/omic data analysis will be prioritized.
• Track record of successful internal and/or external scientific collaborations.
• Experience in managing and/or mentoring more junior scientists. #J-18808-Ljbffr