About this role
Shanghai, China | full time | Job ID: 11325 Position Summary: The main responsibility of this role is to provide project overarching analytical support within the China organization and serve as a local interface for all clinical and commercial CMC project teams with Chinese collaboration partners, CDMOs, and vendors. Specific tasks of this position include engaging directly with local collaboration partners, CDMOs, vendors, etc. to facilitate analytical transfers and supportquality control for mAb and ADC projects. This role also involves supporting operational & troubleshooting activities on-site. Your main responsibilities are: On-site operational support at collaboration partners and CDMOs for AS&Tand quality control to support analytical transfers (ad-hoc site visits for troubleshooting etc.) Review project documentation, including method development reports, analytical procedure protocols, method qualification/validation reports, according to regulatory guidelines Independently drive assigned analytical packages within global technical operations Ensure translation of technical documents for analytical transfer activities Organization of technical visits at collaboration partners, CDMOs or vendors Subject matter expert support for internal audits and Health Authority inspections What you have to offer: Master’s degree or preferably PhD in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology, or a comparable field with at least 5 years of relevant professional experience in an international and highly regulated environment Proven experience in protein and ADC analytical technologies (physico-chemical assays, functional assays, quality control); knowledge in small molecule analytics is considered a plus. experience in analytical activities oflate-stage and commercial projects, including strategy definition and strategy execution, with a sound understanding of all stages in the drug development process. Sound GMP knowledge and experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA) Excellent project management skills, capable of working in cross-functional CMC teams and with external stakeholders Excellent communication and negotiation skills as well as ability to communicate complex technical matters concisely to various stakeholders