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The role
requires understanding in pharmacokinetics, immunogenicity, pharmacodynamics,
protein chemistry and cell biology. The
desired candidate is expected to have
a basic understanding of the principals related to the discovery and
development of new biologic entities
(predominantly antibody-based) and biosimilar molecules
in support of multiple disease indications. His/her functions will include but are not
limited to the implementation of immunoassays for determination of drug in biological matrices, assessment of drug immunogenicity, and measurement
of biomarkers under supervision for supporting AstraZeneca
projects of biologics subject to
clinical analysis.

該職位需要了解藥代動(dòng)力學(xué)、免疫原性、藥效學(xué)、蛋白質(zhì)化學(xué)和細(xì)胞生物學(xué)。期望候選人對支持多種疾病適應(yīng)癥的新生物實(shí)體(主要是基于抗體的)和生物類似物分子的發(fā)現(xiàn)和開發(fā)相關(guān)原理有基本的了解。他/她的職能將包括但不限于實(shí)施免疫測定，以確定生物基質(zhì)中的藥物，評估藥物免疫原性，并在監(jiān)督下測量生物標(biāo)志物，以支持阿斯利康生物制劑項(xiàng)目進(jìn)行臨床分析。

Major responsibilities

? Collaborate with bioanalytical team in ChinaBiolab for successful PK/IMG/PD immunoassay development, trouble shooting,
validation, sample testing and data reporting.

? Perform routine lab operations, such as
preparing reagents/buffers pipetting, weighing, recording, replenishing supplies,
and using instrument/equipment.

? Execute assays1 record observations, analyze data, report results, cross-review studies and archive study records
compliantly and independently with the highest level
of integrity and ethics, and ensure regulatory
requirements (GLP/GCP) and industry
practices are followed.

? Present results at team meetings, prepare study plans/reports.

?與中國生物實(shí)驗(yàn)室的生物分析團(tuán)隊(duì)合作，成功開發(fā)PK/IMG/PD免疫測定、故障排除、驗(yàn)證、樣品測試和數(shù)據(jù)報(bào)告。

?執(zhí)行常規(guī)實(shí)驗(yàn)室操作，如準(zhǔn)備試劑/緩沖液移液、稱重、記錄、補(bǔ)充用品和使用儀器/設(shè)備。

?以最高的誠信和道德標(biāo)準(zhǔn)，合規(guī)獨(dú)立地執(zhí)行分析1記錄觀察結(jié)果、分析數(shù)據(jù)、報(bào)告結(jié)果、交叉審查研究和歸檔研究記錄，并確保遵守監(jiān)管要求（GLP/GCP）和行業(yè)慣例。

?在團(tuán)隊(duì)會(huì)議上展示結(jié)果，編制研究計(jì)劃/報(bào)告。

Education, Qualifications, Skills and Experience

? B.Sc., or above Degree in Biology, Biochemistry, pharmacology or
related field with 3 (B.Sc.), 1 (M.Sc.) or 0 (Ph.D.) years of pharma/Biotech/CRO
industry experience.

? Familiar with immunoassays or ligand-binding assays (LBA) in some or
all the following platforms: ELISA, MSD, cell-based assays, flowcytometry, and
qPCR/PCR.

? Experience on sample testing for PK/IMG/PD in a GxP environment is
highly preferred.

? Attention to details and strong organization/teamwork skills.

? Proficient in both Chinese and English (both written and reading).

要求：

生物、生物化學(xué)、藥理學(xué)或相關(guān)領(lǐng)域的理學(xué)學(xué)士或以上學(xué)位，有一年以上制藥/生物技術(shù)/CRO行業(yè)經(jīng)驗(yàn)。

?熟悉以下部分或全部平臺(tái)中的免疫測定或配體結(jié)合測定（LBA）：ELISA、MSD、基于細(xì)胞的測定、流式細(xì)胞術(shù)和qPCR/PCR。

?具有在GxP環(huán)境中進(jìn)行PK/IMG/PD樣品測試的經(jīng)驗(yàn)者優(yōu)先。

?注重細(xì)節(jié)和強(qiáng)大的組織/團(tuán)隊(duì)合作