大分子药物分析研究员
9千-1.1万·13薪上海市本科不限经验
职位描述
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.
该职位需要了解药代动力学、免疫原性、药效学、蛋白质化学和细胞生物学。期望候选人对支持多种疾病适应症的新生物实体(主要是基于抗体的)和生物类似物分子的发现和开发相关原理有基本的了解。他/她的职能将包括但不限于实施免疫测定，以确定生物基质中的药物，评估药物免疫原性，并在监督下测量生物标志物，以支持阿斯利康生物制剂项目进行临床分析。
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.
?与中国生物实验室的生物分析团队合作，成功开发PK/IMG/PD免疫测定、故障排除、验证、样品测试和数据报告。
?执行常规实验室操作，如准备试剂/缓冲液移液、称重、记录、补充用品和使用仪器/设备。
?以***的诚信和道德标准，合规独立地执行分析1记录观察结果、分析数据、报告结果、交叉审查研究和归档研究记录，并确保遵守监管要求（GLP/GCP）和行业惯例。
?在团队会议上展示结果，编制研究计划/报告。
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、生物化学、药理学或相关领域的理学学士或以上学位，一年以上制药/生物技术/CRO行业经验。
?熟悉以下部分或全部平台中的免疫测定或配体结合测定（LBA）：ELISA、MSD、基于细胞的测定、流式细胞术和qPCR/PCR。
?具有在GxP环境中进行PK/IMG/PD样品测试的经验者优先。
?注重细节和强大的组织/团队合作
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