プロフィール詳細

プロジェクトを作成

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Dr. Lijuan J.に依頼

United States

Director level NGS and IVD specialist on Assay Design, Verification & Regulatory Strategy

プロフィール概要

Innovative scientific leader with 10 years of success in NGS-based LDT/IVD product development under regulated environments. - Led Analytical Validation (AV) strategy and execution for a novel targeted methylation sequencing-based Multi-Cancer Early Detection test, supporting successful product launch. - Named inventor on patents related to optimization of targeted enrichment NGS assays, demonstrating expertise in assay innovation and development.

専門分野

• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ In vitro Diagnostic Design

サービス

• Research
• Product Development

Research Feasibility Study, Gap Analysis

Product Development Stability/Shelf Life Testing, Product Evaluation, Product Validation

職務経験

Staff Scientist

Grail (United States)

8月 2017 - 現在

Director of Development

Grail Inc

8月 2017 - 6月 2025

Senior Scientist

Natera (United States)

4月 2016 - 8月 2017

学歴

Postdoctoral researcher (Pediatrics)

Stanford University

7月 2013 - 現在

Postdoctoral researcher (Medicine)

University of California San Diego

7月 2012 - 6月 2013

Ph.D (Plant Sciences)

University of California Riverside

9月 2006 - 3月 2012

B.S. (Biological Sciences)

China Agricultural University

9月 2002 - 6月 2006

認定資格

• GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)

  CITI Program

  8月 2024 - 8月 2025

出版物

JOURNAL ARTICLE

Zhai J, Zhao Y, Simon SA, Huang S, Petsch K, Arikit S, Pillay M, Ji L, Xie M, Cao X, Yu B, Timmermans M, Yang B, Chen X, Meyers BC, The Plant cell, 2013, vol. 25, no. 7, pp. 2417-2428 .

Li S, Liu L, Zhuang X, Yu Y, Liu X, Cui X, Ji L, Pan Z, Cao X, Mo B, Zhang F, Raikhel N, Jiang L, Chen X, Cell, 2013, vol. 153, no. 3, pp. 562-574 .

Ji L, Chen X, Cell research, 2012, vol. 22, no. 4, pp. 624-636 .

Ji L, Liu X, Yan J, Wang W, Yumul RE, Kim YJ, Dinh TT, Liu J, Cui X, Zheng B, Agarwal M, Liu C, Cao X, Tang G, Chen X, PLoS genetics, 2011, vol. 7, no. 3, pp. e1001358 .

Huang Y, Ji L, Huang Q, Vassylyev DG, Chen X, Ma JB, Nature, 2009, vol. 461, no. 7265, pp. 823-827 .

Yu B, Bi L, Zheng B, Ji L, Chevalier D, Agarwal M, Ramachandran V, Li W, Lagrange T, Walker JC, Chen X, Proceedings of the National Academy of Sciences of the United States of America, 2008, vol. 105, no. 29, pp. 10073-10078 .