Job Summary:
The MST Manager will assist technology transfer from Process development to Manufacturing. He/she will also participate preparation of IND/BLA enabling GMP activities including Process Performance Qualification (PPQ) and assist regulatory dossier writing from CMC perspective, as needed. Other assignments may include but not limited to, help to launch plant-wide lean manufacturing initiative, and collaborate with Finance to establish Cost of Goods (COGs) analysis.

Key Responsibilities:
1. Assist technology transfer from Process Development to Manufacturing.
2. Help to draft PPQ protocols and other PPQ supporting study protocols and reports.
3. Collect process performance and product quality data from GMP batch runs and tabulate for IND/BLA filing
4. Support Process Economy initiatives such as Lean Manufacturing practice and COGs analysis
Qualifications:
1. Master's degree in biochemistry, bioengineering, or biotechnology-related majors. MBA degree is a plus.
2. Fluent oral and written Chinese and English communication skills
3. A minimum of 2 years working experience in a US, European or global MNC biopharmaceutical production setting.
4. Essential knowledge of CMC Development and GMP manufacturing
5. Capable of maintaining positive attitude, always passionate and eager to learn new knowledge and skills. Strong team-player, respect others. Self-driven and willing to embrace new challenges.