Description

Location：Shanghai/Nanjing Job Responsibilities 1. Lead the formulation of analytical strategies for small and large molecule drugs throughout the entire process from IND to NDA. 2. Be responsible for the quality research of active pharmaceutical ingredients (bulk drug substances) and drug products, including method development, validation, transfer, stability studies, and establishment of quality standards. 3. Review and approve critical analytical documents, such as analytical method SOPs, validation protocols/reports, and stability study protocols/reports. 4. Manage the analytical work of CROs/CDMOs, provide technical guidance, and supervise the quality and progress of analytical work. 5. Be responsible for the review of analysis-related sections in regulatory submission dossiers.

Requirements

1. Master's degree or above in Analytical Chemistry, Pharmaceutical Analysis, Pharmacy, Biology, or other related disciplines. 2. More than 5 years of relevant work experience in analytical method development, quality control (QC), or pharmaceutical analysis in pharmaceutical companies or CRO/CDMO organizations. 3. Familiar with pharmacy-related regulations and guidelines, and capable of completing work in a compliant and efficient manner in accordance with relevant guidelines of ICH, FDA, EMA, and NMPA. 4. Experience in NDA submissions is preferred. 5. Experience in large molecule and ADC projects is preferred.

CMC analytical leader

Description

Requirements

InxMed

Pipeline