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Scientist

2 months ago

Seattle, United States ECLARO Full time

Title: Quality - Scientist

Job#: 59421-1

Position Type: Contract/W2

Location: Seattle, WA, United States 98109

Set Up: Hybrid, a minimum of 80% onsite


Description:

Job Title: 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 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 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 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

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

Additional Job Requirements:

Lab w/ blood & animal

Position Handles Hazardous Materials