Upstream Manufacture Function Leader

Job Description

1. Act as USP project function leader to coordinate upstream tech transfer and GMP documents preparation activities and ensure timely delivery.

2. Serve as key contact for clients, US USP manufacture team, and internal groups.

3. Mange timeline, track USP GMP related deliverables, and support CMC project execution.

4. Provide remote support to US USP operations across time zones.

5. Oversee process development, process characterization and process validation activities based on project stage.

6. Handle deviations, change control, CAPA and support audits/inspections.

Requirements

1. ＞5 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.