锦鲤求职岗位描述
Job Description
1. Act as USP function sponsor across multiple projects, coordinating upstream tech transfer, GMP documentation, and manufacturing readiness to ensure on time and high quality delivery.
2. Lead scale-up, tech transfer, and process-related technical issues discussion to ensure the scale up risk be well controlled.
3. Mange timeline, track USP GMP related deliverables, and support CMC project execution across multiple projects.
4. Serve as key contact for clients, US USP manufacture team, and internal groups.
5. Provide remote support to US USP operations across time zones and establish/optimize the upstream tech transfer and scale up platform.
6. Oversee process development, process characterization and process validation activities based on project stage.
7. Handle deviations, change control, CAPA and support audits/inspections.
Requirements
1. ＞7 years upstream experience in biologics.
2. Prior upstream process/manufacture lead/project lead experience preferred.
3. Strong project management and multitasking skills.
4. Excellent communication skills (English & Chinese)
5. Able to support remote collaboration with US team.