Formulation Team Lead, Drug Product Operations

1 week ago


Singapore WuXi Biologics Full time

Formulation Team Lead, Drug Product Operations Support the installation and qualification of new manufacturing equipment, and own/oversee key equipment packages. Develop and implement operational procedures, including SOPs, master batch records, and work instructions. Hire, train, and manage manufacturing staff to support validation activities and batch execution. Ensure adherence to quality standards and client requirements for aseptic processes such as thawing and formulation and other processing steps as required during the initial site startup. Collaborate with Engineering and Maintenance to ensure timely calibration and validation of production equipment. Work with Manufacturing Science & Technology (MSAT), Validation, Quality, and QC teams to ensure procedures are developed and personnel are trained for new product introductions. Stay informed on global regulatory requirements (FDA, EMA, PIC/S, ICH) for aseptic manufacturing and product introduction, and remain up to date on current Good Manufacturing Practices (cGMP). Demonstrate mastery of Quality Management System (QMS) production support systems such as Change Control, Deviation, CAPA, and SAP. Be accountable for the specified cleanroom environment and ensure adherence to stringent requirements, with flexibility to oversee execution during off-hours, if needed. Travel as necessary for project oversight, site visits, and training. Be available for extended periods for overseas training. Interface with clients for technology



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