按省份选择

搜索

国内

北京

上海

广东

北京

上海

广东

北京

上海

广东

北京

上海

广东

北京

上海

广东

北京城区

广州

深圳

广州

深圳

广州

深圳

广州

深圳

广州

深圳

广州

深圳

广州

深圳

广州

深圳

广州

深圳

广州

深圳

生物制药工艺研发 - ADC偶联主任科研员 20-25K

广州市 3年以内 博士 生物制药研发
包含三餐、全员持股
立即申请

广州百济神州生物制药有限公司

企业 | 500-999人

收藏
职位描述
01

岗位职责

Responsible for the design of experiments of ADC conjugation buffer screening, antibody-drug ratio optimization, draft the development reports, to support the process development and project progress. 负责进行ADC偶联缓冲液筛选、投料比优化的实验设计,并撰写研究报告,以支持偶联工艺开发及项目进度。 Participate in the screening and optimization of ADC linker. Participate in the screening of toxin drugs. 参与进行ADC连接子的筛选和优化。参与进行毒素小分子的筛选。 Responsible for the development, optimization and transfer of ADC conjugation process. Responsible for the review of related documents. 负责ADC偶联工艺的开发、优化和转移,及相关文件的审阅。 Draft ADC conjugation related study protocols, follow up the implementation of study protocols, and draft reports. 撰写并跟进ADC偶联相关研究方案,撰写研究报告。 Responsible for the establishment and qualification of the scale-down model of ADC conjugation process. 负责进行ADC偶联工艺缩小模型的建立及确认。 Participate in the process characterization studies and tech transfer projects (ADC conjugation part). Cooperate well with DSP&QC&MST&MFG to promote project progress. 参与工艺表征研究和技术转移工作(偶联工艺部分内容),与纯化、QC、MST及生产部门紧密配合,推进项目进展。 Support regulatory submissions by authoring relevant sections of IND, BLA/NDA and replying to health authority inquiry. 通过撰写IND、BLA/NDA的相关章节和回复监管部门的询问来支持注册提交。 Responsible for providing guidance and training about experiment design, study design and troubleshooting to junior colleagues. 负责对下级同事提供实验设计、研究设计及偶联工艺问题解决方面的指导和培训。 Responsible for the IQ, OQ and PQ of related instruments. Responsible for the daily work of the laboratory. 负责相关仪器的安装确认、操作确认和性能确认,负责实验室其他日常工作。 To comply with the requirements of the EHS policies and regulations. 遵守EHS相关政策法规的要求。 Any other assignment as is determined by supervisor. 完成上级安排的其他工作。
02

任职要求

Ph.D. degree, skilled BS or MS in Analytical Chemistry, Chemistry, Biochemistry or related fields. 分析化学、化学、生物化学或相关专业博士学历(或经验丰富的学士或硕士学位)。 Be familiar with the semi-specific and site-specific conjugation process of ADC drugs, such as cysteine-based conjugation, lysine-based conjugation, unnatural amino acid conjugation, enzyme catalyzed conjugation, et al. 熟悉多种ADC药物的半定点及定点偶联技术,如赖氨酸残基偶联、半胱氨酸偶联、非天然氨基酸偶联、酶催化偶联等。 Be familiar with the screening and optimization of ADC linker and toxin drugs. Be familiar with the structure and process of antibody. 熟悉ADC药物连接子和小分子药物的筛选及优化,熟悉抗体结构与工艺。 Be familiar with the experiment design of ADC process development, be familiar with process optimization. 熟悉药物工艺开发实验设计及工艺优化 Be familiar with the ADC conjugation buffer screening, antibody-drug conjugation ratio optimization, conjugation design of experiment. 熟悉ADC药物偶联工艺的缓冲体系筛选、投料比优化,及相关的DoE实验设计。 Strong laboratory analysis skills, and trouble shooting ability. 具有较强的实验室分析能力,良好处理问题的能力。 Demonstrated experience in designing, developing, optimizing and troubleshooting assays is required. Knowledge of CMC regulatory requirements (FDA, EMA, NMPA, ICH). 具有实验设计、开发、优化和问题解决经验。了解CMC相关法规要求(FDA,EMA,NMPA,ICH)。 1 ~ 3 years of practical experience in Bio-pharmaceutical industry for Ph.D. degree. 博士学历医药行业1 ~ 3年生物制药经验。 5 ~ 6 years of practical experience in Bio-pharmaceutical industry for MS degree. 硕士学历医药行业5 ~ 6年生物制药经验。 7 ~ 8 years of practical experience in Bio-pharmaceutical industry for BS degree. 学士学历医药行业7 ~ 8年生物制药经验。Strong interpersonal, and time management skills with excellent verbal and written Chinese and English communication skills. Familiar with computer operation and office software. 较强的人际关系和时间管理能力,优秀的中英文口头和书面沟通能力。熟悉计算机操作和办公软件。 Proactive and dedicated with a strong sense of responsibility and integrity; 积极敬业、主动进取、责任心强、正直向上; Competent in organization and coordination, team spirit, analytical skills and problem solving; 有较强的组织协调能力、良好的团队精神、较强的分析和解决问题的能力 Good communication skills; 具有良好的沟通表达能力; Strong interpersonal, and time management skills. 较强的人际关系和时间管理能力。
03

工作地点

单位介绍查看所有职位>>

广州百济神州生物药生产基地始终坚持药品高质量、建设高速度和工艺高科技。按照中国、美国和欧盟GMP质量管理规范,广州基地秉承“全球品质、供应全球”的建设目标,已建立起一套国际领先水平的质量管理体系,广州基地一贯专注建设自主生产能力,通过创造速度和成本优势,保持高度灵活性,从而更有效地实现管线产品商业化,为中国生物药生产基地树立新标杆。
x