Job Responsibilities:

1. Manage CMO to ensure timely execution of CMC project with high quality data.
2. Conduct team meetings with internal and external stakeholders; develop agenda, meeting minutes, and action items for team members.
3. Ensure that project timelines, milestones and cost commitments are met.
4. Act as point of contact for project reporting & update.

Job Requirements:

1. Master or higher in a scientific discipline.
2. Solid knowledge in antibody CMC, including cell line development, process development, protein analytic sciences, and GMP manufacturing.
3. Demonstrated experiences in managing therapeutic antibody CMC projects.
4. Must have good interpersonal skills and experience building positive working partnerships with CRO or CMOs.
5. Proficient in both English and Mandarin is a must.
6. Familiar with FDA or CFDA regulations in CMC.
7. Previous experiences in preparing CMC documents for IND filing are highly desirable.
8. Formal project management training and Project Management Professional (PMP) certification preferred.
9. Proficient in MS Office (Word, Excel, Project, Outlook).

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