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1、Extensive knowledge of CDMO services within the Large Molecule space, including CMC project process for cell line development, process development, pilot-scale production, etc. Be familiar with all requirements of IND filing.
2、Develop execution plans and timelines for CMC projects, and coordinate CMC functional departments to execute related contract services. Manage all aspects of CMC project operations, and ensure client satisfaction.
3、Organize regular project meetings with functional departments and clients to update actual working progress and jointly make plans for the next phase.
4、Do resource allocation and time management to ensure that the project will be completed on schedule and on time delivery, and will fulfill quality requirements.
5、Do risk management. Have the ability to proactively identify project risks and challenges, as well as the ability to align resources and propose the corresponding solutions.
6、According to project timelines, assist the finance team with deliverable confirmations at project milestones and cost accounting.
7、Summarize project experience regularly, including the technical aspect, working progress and cost control. Improve project management efficiency through data collection and analysis.
8、Assist to establish standardized executing process for project management and improve system construction.
1、Have excellent communication skills. Have strong ability to implement, organize and coordinate. Be good at time management and process management.
2、Bachelor degree or above in biological sciences, pharmacy or other related majors. Experience in project management is preferred.
3、Experience in R&D and/or industrialization of biomacromolecule is a plus.
4、Experience in physicochemical analysis and/or mass spectrometry of large molecules is a plus.
5、Be hard working, patient, careful and efficient. Have strong logical thinking ability.