職位描述

? Lead and support tech transfer and manufacturing activities (Cell Culture, Purification and Fill/Finish) for the designated production projects at MFG facility. Serve as CMC leader or single point of contact (SPOC) in the overall CMC team and when interacting with external clients for manufacturing related discussions o Lead the MFGandtech transfer activities including gap analysis, manufacturing process discussion, manufacturing document preparation. o Clearly understand and be responsible to track status of MFG and tech transfer, production progress and technical challenges/achievement of production projects, and make appropriate presentation to clients and management o Ensure client requirements are clearly communicated to production team and management o Write technical and production reports per requirement of the projects assigned o Lead/support for preparation and hosting of regulatory inspection and client/QP audit of MFG for projects assigned o Participate in the review/translation of production batch records, deviation, change control, CAPA and regulatory observation response of projects assigned ? Host client visit and present overview of MFG facility and capability ? Address regulatory observations/audit findings and CAPA of projects assigned ? Participate in PD/QA/QC/AD/MFG technology communication and MFG manufacturing summary, more specifically continuous improvement of o Facility, especially USP/DSP/Fill/Finish system, establishment (including documentation and initial setting up - i.e. IOPQ) o PD/MFG platform technology alignment o Optimization of production execution processes o Reduction of deviations/investigations from technology aspect o Work with various MFG teams (and lead as appropriate) on initiatives including, but not limited to, business process improvements, SOP/MBR template updates, production scheduling optimization etc.