上海招聘

工作职责：

1. 在单克隆抗体产品开发项目过程中，负责主导理化分析方法（包括SEC、CEX、cIEF、CE-SDS、MS等）开发、方法验证及方法转移；

2. 制定并执行用于IND和BLA申报的单克隆抗体特征分析方案，主要包括通过结构和降解通路特性及稳定性相关研究，为剂型开发提供支持；

3.负责新检测技术的评估和应用；

4.具有跨部门沟通能力，有效跟进及沟通项目进度；

5.积极主动，能够在最小限度监管下有效管理多个项目；

6. 能够主动承担多种职责，具有良好的决策能力。

任职要求：

1.硕士或同等学历，并拥有至少5年以上相关工作经验；或博士学历，拥有2年以上相关工作经验者优先；

2.分析化学、生物化学、生物物理学、制药化学或相关专业；

3.熟悉cGMP、药典检测、生物药品申报和注册法规者尤佳；

4.熟悉文献查阅，英语优秀，能流利阅读和翻译英文文献；

5.具备良好的敬业精神，团队合作精神和沟通协调能力。

Job Title: Scientist

Department: Analytical Science & Quality Control

Report to: Department Manager

Job Description:

1.In the process of monoclonal antibody product development project, responsible for leading analysis method development(SEC、CEX、cIEF、CE-SDS, MS,etc.), validation & methods transfer to meet timeline of drug development and manufacturing.

2.Develop and implement for IND and BLA monoclonal antibodies to declare characteristics analysis, mainly including the structure and the degradation pathways through characteristics and stability of related research, provide support for formulation development.

3.Responsible for the assessment and application of new detection technology;

4.Communicate effectively about ideas, project goals and results with cross-functional team members.

5.Self-motivated, able to manage multiple projects under minimal supervision;

6.Be Able to take the initiative to undertake a variety of responsibilities, good decision-making ability.

Job Requirements:

1.The master's degree or equivalent, with at least 5 years of relevant working experience; Or PhD degree with at least 2 years of relevant working experience.

2.Major in Analytical chemistry, biochemistry, biophysics, pharmaceutical chemistry or related disciple.

3.Be familiar with cGMP, pharmacopoeia testing, biological medicine declaration and registration regulations is preferred.

4.Familiar with literature research, good communication of Good knowledge of English (oral and written). Desirable knowledge of site language.

5.Good professionalism, teamwork and communication skills.

  

上海臻格生物技术有限公司（以下简称“臻格生物”）成立于2017年，是一家注册于中国（上海）自由贸易试验区临港新片区的高新技术企业。臻格生物在上海周浦国际医学园区、美国马里兰州设有研发中心，在上海临港生命蓝湾拥有cGMP中试和商业生产基地。臻格生物的核心业务为大分子生物药CDMO服务、哺乳动物细胞培养基开发及生产等，具体包括：大分子药物成药性分析、大分子药物的CMC临床申报总包、细胞株开发、工艺开发与优化、中试生产、临床样品生产和商业化CMO服务、工艺表征与验证研究、药物分析服务、细胞培养基配方开发和商业化生产等。臻格生物将通过从临床前研究到商业化生产的一体化CDMO服务和国产化定制细胞培养基产品，助推和加速国内外药企的大分子生物药物的研发和产业化进程。