Director, Cell Culture Process Development - 细胞培养工艺开发总监

Summary

As the Director of Cell Culture Process Development within the Global Development and Technical Operation (GDTO), the candidate will lead a team of 20–30 scientists and engineers to drive late-stage biologics development towards BLA and commercialization.

Specifically, the candidate will oversee cell culture process optimization, tech transfer and process characterization, and support BLA readiness activities. Beyond leadership in pipeline advancement, the candidate will also be responsible for driving technological innovation, bioprocessing digitalization and standardized workflows into project execution, improving organization efficiency and delivery quality.

Key Responsibilities

Team Leadership: Lead and mentor a high-performing team of 20–30 upstream scientists and engineers, fostering a culture of technical excellence, collaboration, and continuous platform improvement.

Late-Stage CMC Development: Drive effective strategy development for cell culture process development, media optimization, tech transfer and scale-up to ensure robust and scalable commercial upstream processes. Oversee seamless execution of late-stage PC programs, including risk assessments and control strategy following the QbD principles.

Client Engagement and Business Development: Lead technical discussions with global clients regarding late-stage upstream strategies, process characterization scopes, and BLA timelines. Translate complex scientific data and late-stage workflows into clear value propositions that win client confidence.

Innovation and Platform Advancement: Pioneer the development and implementation of industry-leading innovation for continuous platform enhancement from the perspectives of operation efficiency, project execution quality and manufacturing cost-effectiveness.

Cross-Functional Collaboration: Serve as the upstream lead interfacing with CMC, MSAT, MFG, and Project Management to ensure successful tech transfer and project delivery.

Requirement:

Education: PhD in Biochemical Engineering, Biotechnology, Biology, or a related field.

Experience: 5+ years in upstream development, with 2+ years of people management experience overseeing mid-to-large teams.

Technical Expertise: Deep technical experience of mammalian cell culture, bioreactor scale-up/scale-down principles, and advanced statistics.