Summary：
Seeking a DP MSAT professional to lead drug product technology transfers, process validation, and manufacturing support; collaborate with CMC teams and sites to ensure robust production (from clinical to commercial) and lifecycle management.
Job Responsibilities：
The detailed responsibilities include but are not limited to the following:
1) Strong English communication and collaboration skills to work closely with internal and external teams (e.g., PD, MFG, QA, ENG).
2) Responsible for drafting DP MSAT-related documents, analyzing production and development data/reports to ensure the authenticity and integrity.
3) Coordinate schedules between development and production teams to ensure reasonable timelines for technology transfer projects.
4) Responsible for Change Control and Deviations across clinical/late-stage/and commercial phases of projects, and establish CAPA plans.
5) Provide technical support and troubleshooting for sterile drug product manufacturing.
6) Support regulatory filings (e.g., BLA, MAA), regulatory inspections and audits
7) Perform laboratory work as required, organize experimental records and data in compliance with company requirements.
8) Flexibility to support PIP across multiple sites (Shanghai/Suzhou/Wuxi/Hangzhou/Chengdu) is a plus.
Qualification：
- Master or Ph.D in Chemical or Pharmaceutical Engineering, Biotechnology, Chemistry or related field.
- 3+ years of experience in MSAT, process engineering, or manufacturing (biotech/pharma preferred)
- Experience in commercial biological drug products is a plus.
- Good communication and teamwork skills, good English is preferred.
- Strong knowledge of cGMP and regulations relevant to pharmaceutical industry is preferred.
- Certain experience with sterile drug product process development, improvements and tech transfer, lyophilization injectable related experience is a plus.
- Experience with statistical data analysis or skilled in database operation is a plus.