杭州招聘

Responsibilities:                                                                                                                     

1、As a senior member of Analytical Sciences organization, be responsible for the overall development strategy for bioassays and other bioanalytical methods, under the guidance of AS Head.

2、Develop and qualify bioanalytical methods (ELISA and cell-based bioassays, impurity assays, binding affinity assays) to ensure their suitability for the intended use and ability to meet ICH and country-specific regulations.

3、Responsible for the establishment and monitoring of product quality standards in assigned clinical-stage drug development programs or commercial stage process transfer/improvement programs

4、Responsible for compliance to all applicable Data Integrity and Good Development Practices requirements for assigned methods and/or projects

5、Responsible for method transfer to HJB Quality Control, and method transfer to/from external laboratory testing functions, for assigned methods/projects

6、As a key Subject Matter Expert (SME) for Bioassay/Bioanalytical methods, contribute to complex laboratory investigations for related methods and manufacturing deviations e.g. OOS/OOT results

7、Responsible for continuous improvement of established methods and development of new technology-based bioanalytical methods

8、Coaching/leading junior members to enhance team capabilities

Qualifications:l

1、Advanced degree (Master, PhD is preferred) in Life Sciences, Biology, Biochemistry, Analytical Chemistry, Immunology, or related disciplines

2、10+ years of relevant experience for Master degree holders; or 5+ years of relevant experience for PhD degree holders

3、In-depth knowledge of large-molecule therapeutics in areas of bioprocess, structure-function, bioanalysis, biologics mechanism of action (MOA), cell signaling

4、Good knowledge in modern analytical instrument in bioassay/bioanalytical applications

5、Experience in analytical method development/qualification during large-molecule development; experience in leading analytical and/or CMC development project is highly preferred

6、Rigorous, diligent, eager to learn and good team player; strong problem-solving skills;

7、Highly proficient in spoken and written English and English-Chinese translation.

创胜集团是一家在生物药研究、开发和生产方面具有全整合能力的处于临床阶段的生物制药公司。公司已成功搭建了全球的业务布局：在苏州设有药物发现、转化研究和临床研究中心，在杭州拥有工艺与产品开发中心和下一代的 GMP 抗体药物生产基地，并在上海、北京、广州和美国普林斯顿、波士顿分别设有临床开发中心和报批中心。创胜集团的开发管线涵盖肿瘤和经筛选的非肿瘤领域的十余个新药分子。截至目前，公司的融资总额已超过 2.3 亿美元。
创胜集团旗下杭州奕安济世生物药业有限公司致力于为生物药创新伙伴提供优质、可靠、快速的 CDMO 完整服务，并通过技术创新及连续化生产，极大加速开发进程和降低生产成本。目前，奕安济世在杭州拥有研发中心及 GMP 生产基地，具备包括细胞系开发、工艺开发、分析和制剂开发、质量标准、稳定性研究、临床样品生产和注册申报等全流程能力。

我们将为你提供：
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完善的基础福利：累进制年休假，五险一金，商业保险，年度福利体检，保障身心健康，放心工作；
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丰富的员工活动：每月生日会、部门团建，传统节日不仅有温暖的节日礼品，还能在公司温暖过节，年年有惊喜；
多样的人才补贴：专业团队负责申请各种政府人才补贴；
额外的重磅福利：期权，海外进修机会，给优秀的你准备着！


公司地址：杭州经济技术开发区福城路291号东部医药港小镇3号楼
联系方式：Vivian Hu 0571-28279502-8513