(Associate) Principal Bioanalysis Scientist
AstraZeneca · Shanghai Jing'an
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Role summary
AstraZeneca seeks an Associate Principal or Principal Bioanalysis Scientist to lead clinical bioanalysis projects for cell therapy and biotherapeutic development in the Shanghai office. The role involves developing and validating assays, managing studies with internal teams and CROs, and supporting regulatory submissions in a GxP environment.
What they're looking for
- Degree in Biology, Biochemistry, Pharmacology, or related field
- Hands-on experience developing and validating LBA, ddPCR/qPCR, and flow cytometry assays in GxP environment
- Experience with bioanalytical method validation per ICH M10, FDA, and EMA guidelines
- Fluency in written and oral English and Chinese communication
- Ability to manage multiple projects concurrently and meet delivery timelines
- Pharma or biotech industry experience
What you'll be doing
- Lead clinical bioanalysis projects as principal investigator, overseeing assay development, qualification, validation, and implementation
- Manage in-house and outsourced bioanalytical studies in collaboration with internal teams and CROs
- Design, execute, and review experiments for PCR-based, LBA, and flow cytometry assay validation
- Review and approve sample analysis data, validation protocols, and regulatory submission contributions per GLP/GCP compliance
- Mentor junior scientists on experiment planning, troubleshooting, and data interpretation
Privacy & handoff
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