Sr. Manager/Assistant Director, Downstream cGMP Operation
This position is based in Wuxi, China, reporting to Senior Director of Bio-manufacturing at WuXi AppTec.
Downstream Operations is responsible for protein purification operations at WuxiApptec biological clinical manufacturing facility in Wuxi, China. The main function of downstream operation team is conducting the downstream unit operations to produce the MAb and recombinant protein drug substance in cGMP environment. The operations include clarification (centrifuge and depth filtration), multi-stage chromatography operations, viral inactivation/removal, UF/DF, formulation and bulk fill. In support of the main function, the additional activities include, assisting IQ/OQ/PQ of new equipment, cleaning and sterilization of process equipment, and buffer preparation.
The Sr. manager/Associate Director is responsible for managing a downstream operation team consisting of supervisors and manufacturing operators, overseeing the technical transfer of process, scheduling the campaign preparation and execution to meet the project objectives and timelines, ensuring the execution of production across multiple shifts, leading the critical deviation investigation and CAPA execution, and managing team members training and performance.
- BS with 8+ years/, or MS with 5+ years, or PhD with 2+ years downstream production experience in a cGMP manufacturing environment
- At least 2 years people management experience
- Experience in the large-scale chromatography, centrifuge and depth filtration harvest, ultrafiltration/ diafiltration, and viral inactivation and removal
- Experience in working with the cross-functional teams.
- Experience in troubleshooting and investigation of critical deviation, and making the risk analysis in a cGMP environment
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