China Leading Company
Strong Technology Team and good work environment
About Our Client
China leading IVD and Biotechnology solutions provider
- Working with Quality Assurance, develop SOPs and guidelines related to the production, planning, disposition and management, materials, etc.
- Lead CMC activities of protein based drug development and manufacturing. Provide leadership to all aspects of CMC Team activity.
- Prepare CMC regulatory filing sections (domestic and international) working with Regulatory and Quality.
- Develop production plans to support preclinical, clinical and adjust plans as appropriate to meet corporate objectives.
- Select and manage the CRO company.
The Successful Applicant
- MS with 10 years or Ph.D. with 8 years of work experience in CMC project management, development, scale-up and clinical development and manufacturing in the biotech or pharmaceutical industry；
- Good understanding of ChP, ICH, GxP guidelines and NMPA/ FDA regulations relating to CMC-related areas;
- Experience in two or more functional areas in cell line development, cell culture, purification, analytical, formulation, QC, QA, project management in the biologics industry；
- MS or Ph.D. degree in life science preferring cell biology or chemistry.
What's on Offer
- Cozy and profitable company
- High potential development career