M&S-Analytical Expertise and Transfer Manager-Beijing
Core
Leading analytical method transfers and validation to ensure best-class medicines are delivered to patients.
Role type
Senior IC analytical expertise and transfer manager
Builds
High-quality pharmaceutical products for patients
Domain
Healthcare / Pharmaceutical manufacturing
Required skills
Analytical method transfer, validation according to regulatory guidelines, trend analysis, technical troubleshooting, risk assessment, regulatory compliance (FDA, EMA), team management, training
Preferred skills
Knowledge of state-of-the-art technologies, MSAT ownership, ALCM strategy
Technologies
Lab instruments, automation equipment, analytical methods
Responsibilities
Leading analytical method transfers to the lab, ensuring methods are validated per regulatory guidelines, coordinating validation/transfers protocols, performing trend analysis on method performance, providing technical expertise and troubleshooting, writing and maintaining procedures and validation plans, training QC staff, conducting risk assessments, evaluating new technologies, supporting audits and inspections, managing and training the team, performing regulatory surveillance.
Seniority
Senior, hands-on IC
