药明生物
Site Microbiologist
岗位职责
Required Qualifications:
• Bachelor’s degree or above in microbiology, environmental microbiology, medical microbiology, food microbiology, pharmaceutical sciences, biotechnology, or related scientific discipline.
• 7-10 years of relevant experience in plant microbiology, pharmaceutical microbiology, biotechnology manufacturing, food microbiology, or another regulated manufacturing environment.
• Strong understanding of microbiological principles, microbial contamination control, environmental monitoring, microbial risk assessment, and GMP expectations in a manufacturing environment.
• Practical experience supporting investigations, root cause analysis, CAPA definition, technical documentation, and inspection of readiness activities.
• Working knowledge of EU GMP Annex 1 expectations and their practical application to sterile manufacturing, contamination control, or microbiological control programs.
Preferred Qualifications:
• Master’s degree or higher in microbiology or related discipline.
• Experience in biologics, sterile manufacturing, aseptic processing, contamination control strategy, utilities monitoring, or environmental monitoring programs.
• Experience interacting with internal auditors, customers, regulatory inspectors, or global quality teams.
• Demonstrated ability to translate microbiological data and risk assessments into clear technical conclusions and practical site actions.
任职要求
• Bachelor’s degree or above in microbiology, environmental microbiology, medical microbiology, food microbiology, pharmaceutical sciences, biotechnology, or related scientific discipline.
• 7-10 years of relevant experience in plant microbiology, pharmaceutical microbiology, biotechnology manufacturing, food microbiology, or another regulated manufacturing environment.
• Strong understanding of microbiological principles, microbial contamination control, environmental monitoring, microbial risk assessment, and GMP expectations in a manufacturing environment.
• Practical experience supporting investigations, root cause analysis, CAPA definition, technical documentation, and inspection of readiness activities.
• Working knowledge of EU GMP Annex 1 expectations and their practical application to sterile manufacturing, contamination control, or microbiological control programs.
Preferred Qualifications:
• Master’s degree or higher in microbiology or related discipline.
• Experience in biologics, sterile manufacturing, aseptic processing, contamination control strategy, utilities monitoring, or environmental monitoring programs.
• Experience interacting with internal auditors, customers, regulatory inspectors, or global quality teams.
• Demonstrated ability to translate microbiological data and risk assessments into clear technical conclusions and practical site actions.
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