Biotech Scientist

Zhen Li M.D

Address Thornhill, ON, L*J *B*, Canada (In Great Toronto Area)

Tel: 647-***-****(Cell) 416-***-****(H)

Email: ********@*****.***

Visa: Canadian Citizen, TN visa for US job

Summary

5 years of biotech scientist in Canadian pharmaceutical industry, 10 years of academic research experience in US and Canada, 4 years of medical executive in a US-owned biotech company in China .

Skills

Pharmaceutical

cGMP, GLP,GCP knowledge and practice.

Analytical test validation, verification, qualification and QC assays

Small Molecules tests such as HPLC, GC, TLC,FTIR, UV/vis, KF,LDM etc

Biologic tests such as ELISA,,SDS-Page, Western blot, LCMS/MS etc

Bacterial Endotoxin test (LAL chromogenic,turbidimetric kinestic and endpoint) in different drug or medical device samples.

Biotechnology/Microbiology/In Vivo

Mamalian,bacterial & yeast cell culture, Stem cell culture and handling

Handling of transgenic mouse & animal surgery in mouse, rat and rabbit

Molecular cloning with plasmids and virus vectors, mutagenesis test

Southern blot, PCR & qPCR

Protein interaction analysis, peptide array.

Immunohistochemistry, immunoflurescence and other immunoassay,

Flow cytometry techniques, magnetic cell separation

RIA, liquid scintillation assay of radioactive isotope

Global Drug Development

New Drug development in preclinical, clinical trial and new drug regulation affairs.

Gene therapy and other new therapies’ global development experience

Professional Experience

Scientist Jun,2012 Jan,2017

Biotech Service

SGS Canada InC

6490 Vipond Dr, Mississauga, ON,Canada

Design and implement Validation, Verification and QC analytical tests following cGMP or GLP

Perform Quality procedures such as Change management, Deviation investigation etc.

Calibration and validation of data and instruments

ELISA based test, SDS-PAGE, Westen blot, LC-MS/MS tests.

Cell-based Bioassays, enzyme activity assays

Bacterial Endotoxin test with LAL chromogenic, turbidimetric kinetic or endpoint on different drug or medical device samples

Molecular biology test for cell banking, mutagenesis etc

HPLC, GC, TLC test

Karl Fischer moisture test, sample particle test

UV/vis, FTIR, MS/MS test

Perform testing on raw materials, in-process, finished product, packaging, and stability samples

Protocol,method, SOP and report draft writing

Research Associate Nov,2009 Jun,2012

Dept Biochemistry

University of Toronto

1 King’s College Circle, Toronto, Canada

Identification & characterization of Novel interactors of Prion protein

Contribution in finding a new mechanism of Prion disease

Plasmid cloning,transfection, selection and verification

Co-Immunoprecipitation, Western blotting

Immunoflurescense

Write manuscript, make presentation.

Research Fellow Sept, 2006 April,2009

Molecular Structural & Function Division

Hospital for Sick Children

555 University, Toronto, Canada

Mechanism of rise of Multiple Sclerosis

Mechanism of PAD inhibitor treatment of Multiple Sclerosis

Management of transgenic mouse and genetic analysis

Southern blotting, PCR, Western blotting

Immunohistochemistry and electronic microscopic techniques.

Flow Cytometry and apoptosis analysis technique

Writing of grant draft and manuscript of papers

Postdoc Associate Dec,2003 May,2006

Pharmacology Department

Loyola University Chicago

Maywood IL 60153, USA

Mechanism of estrogen-induced desensitization of serotonin receptor

Mechanism of antagonist-induced desensitization of serotonin receptor

Perform rat surgery to position cannula, dissect brain

Western blotting and immunoprecipitation

RIA for hormone assay

Phospholipidase C activilty assay

SiRNA adenovirus vect construct and maintain

PC-12 cell line culture and RT-PCR

Postdoc Geneticist Jul,2002__Nov,2003

Life Science Division

Lawrence Berkeley National Laboratory/ UC Berkeley

Berkeley CA 94720, USA

Identify and characterize genes contributing to radiation-induced Thyroid Carcinoma

Culure and clone primary tumor cells

Prepare cell metaphase

Perform FISH,SKY and analyse their karyotype by microscope and digital image (Cytogenetics)

Mapping breakpoint of translocation in chromosome with BAC or YAC clone probes

Perform PCR,RT-PCR

Medical Director Feb,1999__July,2002

Shanghai Sunway Biotech InC ( A well-known US-China joint-ventured company)

Shanghai China

Playing key role in development of Oncorine(H101), the first approved oncolytic adenovirus New Drug in the world.

Familiar with regulations and connections for global development of New therapeutics

Prepare and present project plan, negotiation with 3rd parties.

Managing preclinical tests( Efficacy, toxicity etc)

Designing clinical protocol following ICH GCP

Designing clinical research forms (CRF) and Standard Operation Procedures(SOP)

Monitoring clinical trial

Participating CMC and other development decision making

Prepare and submit application documents to Drug Administration

Coordinate with regulator and experts in China State Drug Administration (CSDA)

Leading a team of more than 20 members.

Education

Master of Science Molecular Biology

Second Military Medical University

Shanghai .China

Doctor of Medicine

Second Military Medical University

Shanghai China

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