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Senior Scientist

2 months ago

Seattle, United States Crox RPO Full time

Job Title: Scientist/Senior Scientist - Allogeneic Cell Therapy

Location: Seattle, WA (Hybrid), a minimum of 80% onsite.


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 primary focus of the Attribute Sciences Scientist/Senior Scientist role will be to collaborate with IAS team member to build in depth allogeneic CAR T cell product and manufacturing process data and understanding with particular focus on exploratory/investigational studies to support:

  1. 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
  2. The generation of product quality target product profiles taking into account safety and efficacy of drug products
  3. Support process development studies and investigations by building and mining in depth data packages and generating hypothesis-driven conclusions and proposed risk mitigation strategies
  4. 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 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 agencys 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 novel/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 BMS leadership
  • Serve as T cell biology subject matter expert in multidisciplinary team setting, 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