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... procedures via current documentation guidelines in transition of new R D projects in an efficient manner 2 Is responsible to provide assistance in development of processes, optimization of processes, confirmation of processes, validation and manufacturing of qualifying and pre-licensing serials 3 ...
... procedures * Manage the activities of direct reports to accomplish scope of work of validation department * Manage protocol and report development, execution and approval associated with commissioning and validation, cleaning validation and process validation * Review and approve facility equipment ...
... and safety (EHS) requirements The ideal candidate would possess Experience in validation of Immunogenicity, PK methods. Experience in leading assay development on novel technology Experience in cell-based assays Experience in developing flow cytometry methods Experience with lab automation platforms ...