Senior Scientist-LVV, Process Development

AstraZeneca
Full time China, Shang Hai Shi Life Scientists
Posted:
March 01, 2026
Location:
China, Shang Hai Shi, China

Job Description

Major responsibilities

  • Plan dual-path development strategies for adherent (cell factories/fixed-bed) and suspension (HEK293-based) processes and assess platformization and scale-up pathways.
  • Define the relationships between critical quality attributes (CQAs) and critical process parameters (CPPs) to establish the upstream control strategy and design space (proven acceptable ranges, PAR), supporting late-stage regulatory filings.
  • Optimize upstream processes (, DNA:PEI ratio, plasmid quantity, cell density, temperature/DO/pH, feeding and medium exchanges, harvest window) and implement robustness-by-design to mitigate inter-batch variability.
  • Develop scale-up strategies, execute engineering runs, and support late-clinical/PPQ readiness.
  • Transfer the process to internal GMP manufacturing or CDMOs, author process development reports, batch records, SOPs, and risk assessments (FMEA).
  • Lead or contribute to quality activities during manufactur...
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    Job Overview

    Job Type: Full time
    Location: China, China
    Posted: March 01, 2026
    Deadline: April 10, 2026