锦鲤求职岗位描述
Key Responsibilities
1、Leads API technology transfer to CDMOs, managing process development/validation across clinical to commercial stages. Coordinate cross-functional teams to ensure seamless CDMO project execution.
2、Oversees process development and quality control activities at CRO/CDMOs, encompassing process development/transfer/validation, troubleshooting, deviation investigations, and document review, while conducting on-site monitoring of development and manufacture operations.
3、Prepares and reviews regulatory submission documents (IND/NDA) and related filings as required.
4、Maintains scientific expertise through literature reviews, conference attendance, and continuous field monitoring.
5、Actively collaborates with other CMC team members or related colleagues to achieve organizational objectives.
Recommended Education and Key Competency
1、Chemistry/Pharmaceutical Sciences degree (Ph.D. with 6+ years or M.S. with 10+ years process R&D experience).
2、 Proficient in process development, optimization and synthetic route design experience; Process validation experience preferred.
3、Thorough knowledge of FDA/EMA/NMPA/ICH guidelines.
4、Fluent technical English reading/writing/speaking (IND/NDA documentation experience).
5、Multitasking and ability to plan and prioritize multiple projects and workload.
6、Strong cross-functional communication and team collaboration skills.
7、Has rich experience in managing CDMOs and CROs.