某外资制药公司
MSAT Scientist
制药
制造与运营
苏州
5-10年
硕士
¥20 - 30K14薪
公司介绍
某外资制药公司
职位描述
Lead tech transfer execution: organize the TT team, develop and manage the project plan with clear milestones, and drive risk and crisis management to ensure on-time, high‑quality transfer.
Maintain data and document Brake: ensure integrity and compliance, oversee the completeness, accuracy, and timely update of technical data and documentation per requirements.
Drive comparability study: design and execute comparability studies for critical changes (e.g., site addition, critical material or process changes, production line expansion).
Perform advanced data analytics: conduct deep, statistically sound analyses to generate insights and inform decisions across development and manufacturing.
Design and execute process related investigations, optimizations, and scale‑up studies to improve robustness, yield, and manufacturability as required.
Resolve manufacturing issues: facilitate timely closure of technical troubleshooting, deviations, changes, and CAPAs, ensuring effective root cause analysis and preventive actions.
Own process validation strategy and execution: design and implement validation studies, including chromatography resin and reusable filter lifetime, mixing, cleaning, and yield studies.
分享