Experience

上海仁会生物制药股份有限公司

• China
• Medical Device
• 1 - 100 Employee

• Senior Manager of Translation medicine

  • Jan 2019 - Present

  Clinical translation research experience, exploratory research on MOA and POC of drug; Clinical biomarker discovery; Biotechnology development; Project management and bio-lab operation. Clinical translation research experience, exploratory research on MOA and POC of drug; Clinical biomarker discovery; Biotechnology development; Project management and bio-lab operation.



HARBOUR BIOMED

• United States
• Biotechnology Research
• 1 - 100 Employee

• Manager of Bioanalysis and Biomarker

  • Jun 2018 - Jan 2019

  1. Take responsible for IO assays and Immunogenicity assays for large molecules(humanized drug antibody), following GLP/non-GLP and the regulatory standards; also bridge the biomarker area; 2. Support preclinical projects with internal clients and outside vendors, providing technology support for various programs and projects under supervision; 3. Assay transfer evaluation and clinical analysis including biomarkers, assure that methods are developed or transferred in accordance to global and local regulations; 4. Sample logistics management support for clinical projects; Interface with Central Labs and clinicians for bioassay training, trouble shooting, and on-site support; 5. Interface with local and global CROs for bioanalysis CRO selection and negotiation, on site visiting, study monitoring and quality assurance; 6. Anticipate potential issues of bioanalysis, proactively provide customized strategy and solutions, utilizing domain expertise and knowledge to make sure success of nonclinical and clinical programs. Show less



Johnson & Johnson Medical

• Hospitals and Health Care
• 700 & Above Employee

• Scientist 4

  • Jun 2013 - Jun 2018

  2013/6--Present: Janssen R&D center, Oncology Department, Biomarker team, Scientist 4 1. Project assistant manager in phase 0 study of SCLC (small cell lung cancer), be responsible for technology and communication work. In technology, a, Build whole process of single cell sequencing, including isolating CTCs (circulating tumor cell), extracting single cell DNA and RNA, constructing library and downstream NGS sequencing (set up QC criterion, part of data analysis). b, Explore and evaluate new vendor to support related project, such as ctDNA (circulating tumor DNA), NGS detection. In communication work, a, Transfer exploring method to CROs, set up SOP and contract negotiation. b, Collaborate with CRC&CRA to manage sample collection and sample shipping for making project go forward smoothly. c, Train related person (hospital and CRO partner) to know well the technology of single cell sequencing 2. Collaborate with phase 2 study of NSCLC (non-small cell lung cancer), be responsible for specific fusion gene detection, develop detection method and transfer assay to CRO for model screening. 3. Collaborate with Lung DAS team to set up new assay for analysis T cell check point by FACS assay, and sorting positive cell to identify drug target. 4. Proficient in cell biology assays that could include ELISA-based assay and cell-based assays, immune cell isolation from whole blood or tissues as well. 5. Be responsible for quantification and quantitation of cytokine in cell signal pathway which stimulate with compounds. 6. Be responsible for biobank management, major for clinical sample including tissue, blood and nucleic acid production, etc. 7. Having capability in Team work and management of multiple experiments simultaneously; Show less



WuXi AppTec

• China
• Pharmaceutical Manufacturing
• 700 & Above Employee

• senior scientitst

  • Apr 2010 - May 2013

  Senior Scientist II, Project Investigation. 1. Be responsible for assay validation and analysis in multiple protein drugs, AMGEN Inc. Project includes Denosumab，Epogen，Anti-human hepatocyte growth factor(HGF), Insulin-like growth factor receptor (IGF-1R). 2.For Bristol-Myers Squibb company, a. Be responsible for sample analysis to Abatacept, BMS844203(CT322). b. Participate in method validation for PEG-IFN-lambda and Pegasys. c. Be responsible for validation and analysis in cell based assay for testing of PEG-IFN-lambda activity. Include cell thaw, split, culture, frozen and testing of neutralized antibody. 3. Participate in method development, validation and sample analysis, Eli Lilly. 4. Participate in method development and analysis for Novartis. Project contains INF-r, sCSF, GM-CSF, Collagen IV and Somatostatin (SOM230) 5. Be responsible for Pfizer’s method validation of Anti-GnRF. 6. Be responsible for cytokines detection in animal tissue for Santaris Pharma Company. Project includes ApoB100 and PCSK9. Participate in series of SPC gene drug analyze in matrix for monkey and mouse. 7. Be responsible for clinical collection with OrienGene (Beijing Biotechnology Ltd.) for recombination of human herpes virus of GM-CSF. 8. Participate in process development of which remove amino acid residue from drug in Shanghai Meiyue Ltd. 9. Manage P2 room and monitor cell room environment, propose effective strategy for sterilization. Protect lab of cell from harmful substance, so that cell based assay go on smoothly. Show less