**Primary Objective**

The Senior Manager will support the manufacture of Drug Product (fill finish, device assembly and secondary packaging) of biologics product. Responsible for activities range from tech transfer, technical process studies, process validation activities, data analysis to handing change controls, deviations and troubleshooting. Writing and reviewing of DP/Device Assembly/FG validation-related documents and key CMC sections of regulatory dossiers (different countries) are also required for this position. In addition, also represent and support supply chain team from commercial and clinical supplies of Biologics.

**Major Duties/Responsibilities**

+ Lead and oversee the operational activities at DP/FG/Device Assembly CMOs; scheduling of batches, commercial manufacturing and testing of DP
+ Responsible to achieve on-time in-full manufacturing of DP/FG/Device Assembly in compliance with approved dossiers in collaboration with Quality Assurance...