cmc pm ad.

about the company.
An international biotech powerhouse driving novel antibody therapies.
 

about the team.
Led by world-class experts with deep domain knowledge in antibody discovery and development.

about the job.

1. Lead the standardization of process characterization, establishing and maintaining best practices for study design, data analysis, and documentation to ensure consistency and quality across projects.
2. Develop and implement CMC project plans based on company development strategies and project objectives, ensuring clear prioritization and focus for each project.
3. Lead CMC project teams to develop timelines, manage milestones, oversee CMO activities, confirm deliverables, control project budgets, and monitor execution progress to ensure alignment with company goals and proactive risk management.

skills and experience required.

1. Master’s degree or above in Pharmacy, Chemistry, Chemical Engineering, Biochemistry, or related scientific discipline. PhD preferred.
2. Minimum of 8 years of relevant experience with a Master’s degree, or at least 5 years with a PhD, in CMC project management or pharmaceutical development. Proven track record in late-stage development and cross-functional team leadership is required. Experience in biologics or ADC development is a plus.
3. Strong knowledge of CMC development processes, regulatory requirements (e.g., IND, BLA, NDA, IMPD), and GMP standards.