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Responsible to supervise and lead the Laboratory release function including Raw Materials, Intermediates, DPI and API’s (including the stability program) and In Process Control and provide core technical support in areas of chromatography,
Lead a team of MSAT Experts who are tasked with technology transfers (process implementation and transfer) and timely process implementation at our aseptic fill&finish line. Manage the MSAT team with full responsibility for all aspects of human resource
Responsible for providing Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsible for preparing and managing CMC regulatory
Responsible for developing and overseeing a robust Quality Assurance strategy focused on the transfer of New Product Introduction (NPI) QC methods to manufacturing sites and Third-Party Laboratories. This role supports the Test Method Gate Review process,
Develop, implement, and maintain the quality management system applicable to R&D activities (SOPs, work instructions, standards, etc.). Ensure compliance of R&D projects assigned to CMO Office with relevant regulations (e.g., GCP, GVP, GMP, GLP, ISO, ICH,