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徐汇区, 上海市, 中国
Onsite
Typical Accountabilities:
Process Development & Execution: Design and execute purification development studies; deliver on-time study updates and propose next-step development plans.
Data & Reporting: Compile, analyze, and ensure data integrity; author study reports and support regulatory/filing documentation.
Tech Transfer & Manufacturing Support: Lead or contribute to downstream tech transfer; align production strategies with manufacturing; provide on-site support for scale-up, troubleshooting, and continuous improvement under GMP.
Platform Analytics & Optimization: Aggregate and analyze historical POC production datasets; identify performance trends and pain points; recommend and drive platform-level process optimization.
Education, Qualifications, Skills and Experience
Master’s degree or above in Bioengineering, Biopharmaceuticals, Cell Biology, Virology, or a related discipline.
4+ years of downstream purification process development experience in biologics, viral vectors, or plasmid DNA, with strong practical skills and solid GLP awareness; candidates with drug product (formulation) process development experience are preferred.
Expert in affinity chromatography, ion-exchange chromatography, hydrophobic interaction chromatography, depth filtration, and tangential flow filtration; proficient in operating chromatography skids and TFF systems.
Good experimental design and data analysis capabilities, with the ability to tackle complex problems encountered during process development.
Proficiency with DoE/statistical tools for study design and multivariate analysis (e.g., JMP, Design‑Expert, Minitab).
Working knowledge of GMP principles and understanding of technical and management requirements related to cell therapy.
Good command of written and spoken English, with the ability to search for and interpret international literature.
Strong teamwork and communication skills.
Date Posted
23-Apr-2026Closing Date
30-Aug-2026AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.