Hengrui Pharma
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???????????????????????????????PD????QA/QC???????????????
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????????????????Deviations/Change Controls???????????RCA??CAPA???
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?????????????????????????????PPQ?
?????? ??BLA/NDA??????CMC?????????????????????? ??????????????????FDA/EMA/NMPA??? ????? ???? ????????????????????????
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GMP??
?????? ???????SCI????????? ????????????????????????????????? ???? ????????????????????????/????????????????? ?????????????????FMEA???????QbD?? ??GMP/ISO????????????????????? ???? ????????
???????????DOE???????????? ??????
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???????????????????????????? ???? ???????????????????????????????????? ???? ????????? Key Responsibilities Lead end-to-end technology transfer for multiple biologics projects (upstream, downstream, fill-finish), defining phase-appropriate strategies and overseeing execution. Review and align cross-functional teams (PD, Manufacturing, QA/QC) on transfer documents including process descriptions, risk assessments, and analytical reports. Draft critical transfer documents such as gap analyses, protocols, and summary reports; track key milestones including materials, equipment, and batch records. Resolve deviations and change controls, drive root cause analysis (RCA), and implement CAPA. Provide process optimization recommendations for commercial manufacturing and support complex deviation investigations and process validation (PPQ). Author BLA/NDA submission documents including CMC sections and process validation reports; respond to global health authority (FDA/EMA/NMPA) queries. Assess regulatory impact of process changes to ensure full compliance. Qualifications Ph.D. in Biopharmaceutical Engineering, Molecular Biology, Pharmaceutical Sciences, or related field. Research background in biologics process development (cell culture, protein purification, formulation stability) or GMP manufacturing. Published papers or patents in related fields (SCI journals preferred). Industry or academic project experience in GMP production or pilot-scale process scale-up. Knowledge of biologics manufacturing processes including mammalian cell culture, chromatography, UF/DF, and aseptic filling; understanding of critical quality attributes (CQAs). Familiar with technology transfer methodologies such as FMEA and QbD; knowledge of GMP/ICH guidelines. Experience in process validation or regulatory writing is a strong advantage. Systematic problem-solving ability with experience using DOE or statistical tools (e.g., JMP, Minitab). Able to clearly convey technical concepts to non-technical stakeholders. Effective in fast-paced environments, skilled at multitasking and managing priorities. Fluent in English (written and spoken); capable of drafting technical documentation and collaborating within global teams. Location Suzhou, Guangzhou, or Lianyungang, China
?????? ??BLA/NDA??????CMC?????????????????????? ??????????????????FDA/EMA/NMPA??? ????? ???? ????????????????????????
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? ???? ?????
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GMP??
?????? ???????SCI????????? ????????????????????????????????? ???? ????????????????????????/????????????????? ?????????????????FMEA???????QbD?? ??GMP/ISO????????????????????? ???? ????????
???????????DOE???????????? ??????
?????????????????????????????? ???????
???????????????????????????? ???? ???????????????????????????????????? ???? ????????? Key Responsibilities Lead end-to-end technology transfer for multiple biologics projects (upstream, downstream, fill-finish), defining phase-appropriate strategies and overseeing execution. Review and align cross-functional teams (PD, Manufacturing, QA/QC) on transfer documents including process descriptions, risk assessments, and analytical reports. Draft critical transfer documents such as gap analyses, protocols, and summary reports; track key milestones including materials, equipment, and batch records. Resolve deviations and change controls, drive root cause analysis (RCA), and implement CAPA. Provide process optimization recommendations for commercial manufacturing and support complex deviation investigations and process validation (PPQ). Author BLA/NDA submission documents including CMC sections and process validation reports; respond to global health authority (FDA/EMA/NMPA) queries. Assess regulatory impact of process changes to ensure full compliance. Qualifications Ph.D. in Biopharmaceutical Engineering, Molecular Biology, Pharmaceutical Sciences, or related field. Research background in biologics process development (cell culture, protein purification, formulation stability) or GMP manufacturing. Published papers or patents in related fields (SCI journals preferred). Industry or academic project experience in GMP production or pilot-scale process scale-up. Knowledge of biologics manufacturing processes including mammalian cell culture, chromatography, UF/DF, and aseptic filling; understanding of critical quality attributes (CQAs). Familiar with technology transfer methodologies such as FMEA and QbD; knowledge of GMP/ICH guidelines. Experience in process validation or regulatory writing is a strong advantage. Systematic problem-solving ability with experience using DOE or statistical tools (e.g., JMP, Minitab). Able to clearly convey technical concepts to non-technical stakeholders. Effective in fast-paced environments, skilled at multitasking and managing priorities. Fluent in English (written and spoken); capable of drafting technical documentation and collaborating within global teams. Location Suzhou, Guangzhou, or Lianyungang, China