- Lead a large group of QC staff managing stability programs by following ICH guideline including stability study strategy, design, creation and review of stability study protocols and study summary reports, and stability data analysis and trending.
- Participate and lead stability investigations.
- Partner cross-functionally to exchange data and present product trending information.
- Communicate and present data to clients effectively.
- Work with project team to coordinate stability and retain samples, and reference standards.
- Oversee QC-SH sample management from sample receiving, login, transferring and disposing.
- Lead the team to create and/or optimize workflow for sample management.
- Manage stability samples and Reference Standards.
- Support audits from health authorities, clients and internal Quality Assurance.
WuXi Biologics
Offering End-to-End Solutions
职位信息
职位信息
Associate Director, QC Stability and Sample Management
Associate Director, QC Stability and Sample Management
中国 shanghai
工作职责：
任职能力：
- Education background in chemistry or pharmaceutical sciences and a MS degree or above is preferable with at least eight years of pharmaceutical industry experience.
- Outstanding oral and written communication skills in both English and Chinese are essential.
- Good project management, time management, and multitasking skills are required.
- Managerial experience by providing on-going mentoring, supervision, and yearly performance review and appraisal of a large group of scientists.
- Experience interacting with clients and health authorities (NMPA, FDA, EMA etc.) preferred.