北京招聘

Key Responsibilities:

1. Lead process-related deviations and provide technical support to manufacturing.
2. Investigate, identify root-cause for critical deviations and determine CAPA for manufacturing.
3. Write product impact assessments to support deviations.
4. Write and review technical documentation (batch records, SOPs, protocols, and reports).
5. Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues.
6. Design and execute process validation studies to develop a thorough understanding of operating and performance parameters.
7. Perform hands-on activities that support process development and process characterization, ranging from drafting procedures to execution of laboratory studies.
8. Support cross-functional technology transfer teams for cGMP.
9. Collaborate with another site or clients to ensure success of scale up/process transfer.

Qualifications:

1. Bachelor or advanced degree in Biochemical, Chemical Engineering or a related scientific discipline such as Chemistry or Biology.
2. Looking for 8+ years’ relevant experience or Master’s degree with 4-6 years’ experience.
3. cGMP pharmaceutical MSAT or technical services, technology transfer or process development experience preferred.
4. Strong interpersonal and communications skills; written and oral in English.
5. Ability to function in a fast-paced dynamic team environment and balance characterization multiple projects
6. Knowledge of cell and gene therapy vector production is desirable.
7. Understands and employs principles and concepts of Lean Six Sigma to improve process capability is a plus.
8. Knowledge of data management tools and statistical process controls is preferred.

金斯瑞生物科技股份有限公司（股票代码HK01548）是全球化的生物科技集团公司。集团植根于领先的基因合成技术，核心业务范围已涵盖生物药开发与生产CDMO业务、细胞与基因治疗、生命科学服务及产品、生物酶及合成生物学产品四大领域。

金斯瑞成立于2002年，并于2015年在港交所主板挂牌上市。集团总部位于中国南京，运营实体遍布大中华区、北美区、欧洲区及亚太区，并以此为依托，为全球160多个国家和地区的10多万客户提供优质、便捷、可靠的服务与产品。

目前，金斯瑞在全球拥有超过3000名员工，其中34%以上的员工拥有硕士或博士学位。金斯瑞拥有多项知识产权及技术机密，其中包含100多项授权专利及270多项专利申请。截至2019年6月30日，有超过40,300篇经国际同业审阅的学术期刊文献引述了金斯瑞的服务及产品。

秉承“用生物技术使人和自然更健康”的企业使命，金斯瑞将一如既往地致力于成为最受信赖的生物科技公司。