Nathan Yee Email & Phone Number

Kirkland, Wa, Us

Kirkland, Wa, Us

Durham, North Carolina, Us

Lawrence Township, Nj, Us

Founder and platform architect for Allogeneic Cell Therapy Technical Development group; accountable for technology design, project strategy, and experimental execution of Allo platform products, while serving as the business partner for research, clinical, portfolio strategy and commercial teams. Director-level leader for engineering integration teams, and matrix leaders across multidisciplinary cell therapy CMC functions (analytical development, quality, regulatory, operations, MSAT, etc.) for early assets. Responsible for overall technical and strategic success of the platform, from technology identification/funneling to regulatory filings in order to address unmet medical needs.

Summit, New Jersey, Us

Founder & product development strategy leader for novel Allogeneic Platform Team. Leveraged portfolio learnings across autologous CAR-T products to derive a production-scale platform for gene-edited T cell therapies - from concept, to technology identification, and end-to-end proof of concept in an accelerated manner. Accessed available resources and adapted a startup mentality to secure budget, apply a rapid-iteration innovation loop, and build a new team of engineers and Ph.D. level scientists. Delivered project collateral (white papers, invention disclosures, technology intelligence reports) that resulted in accelerated sponsorship and enhanced prioritization in the midst of corporate merger dynamics.

Seattle, Wa, Us

Director-level leader of 18 staff across flow cytometry and cell-based assay analytical development teams, consisting of team leaders, Ph.D. Scientists, and project leaders across 6 clinical stage CAR-T products. Successfully delivered functional deliverables across method development, qualification, transfer, and assay lifecycle strategy for internal and external customers. Authored content for BLA and ex-US regulatory filings for Breyanzi, and CMC Analytical Strategy leader for clinical stage orva-cel program. Also served as facilitator for top-end Technical Development governance team, while actively coaching project teams and bridging communication between programs, corporate governance and senior leaders.

Seattle, Wa, Us

Co-founded T cell Product Characterization department, and served as Breyanzi analytical product characterization leader. Responsible for MoA, justification of CQAs (critical quality attributes), CMC correlative analysis, and extended characterization strategy & testing logistics. Chaired the CMC correlative analysis team and served as division representative for Neurotoxicity Working Group.

Seattle, Wa, Us

Founded the Assay Support Group, an operations-focused organization responsible for executing analytics for IND-enabling process development. Built new lab, established KPIs, and developed data reporting infrastructure to execute work in support of clinical stage development. Proactively led matrixed assay teams across Analytical Development and Quality Control to optimize assays and increase performance while reducing data turnaround time, with oversight across multiple assays platforms and technologies (ligand-binding assays, flow cytometry, cell based and potency assays, etc.)

Seattle, Wa, Us

Kagoshima, Kagoshima, Jp

- Architect of GLP-compliant flow cytometry core lab services. Designed SOPs and established best practices to efficiently develop and validate functional and phenotyping assays for regulated pre-clinical studies.- Responsible for all aspects of immunotoxicology evaluation, including study design, data analysis/reporting, benchwork, consultation with Sponsors and Study Directors, and mentorship of analytical scientists and technicians. Tasked with long-term strategic planning and operations of immunology services.- Developed cell-based assays to mechanistically interrogate off-target effects, including drug-induced thrombocytopenia. Led multi-departmental effort to correlate developmental, phenotypic and functional endpoints of primary hemostasis for multiple programs.- Extensive experience in multiparameter flow cytometry profiling of all leukocyte populations, with an emphasis on T, B and myeloid cell activation. Adept at interrogating complex and rare populations in NHPs, including CD34+ stem cells and myeloid progenitors in active bone marrow.- Scientific consultant for diverse therapeutic programs with a specific emphasis on regulatory strategy and study design for immunology-related disease models and test articles.- Manager and scientific lead for analytical scientists, technicians and administrative coordinators. Responsible for establishing scientific rationale, planning logistics, scheduling and directing project teams to create assays that comply with FDA/EMA Bioanalytical guidances and FDA/ICH Immunotoxicology guidances.- Author of immunotoxicology articles and posters. Company-selected speaker for a major industry conference.- Awarded SNBL USA 2013 Employee of the Year.

Seattle, Wa, Us

Seattle, Wa, Us

Seattle, Wa, Us

Doctor Of Philosophy (Ph.D.), Immunology

Bachelor Of Science (B.S.), Microbiology

Bachelor Of Science (B.S.), Biochemistry