( Associate) Principle Scientist - Car-t

AstraZeneca

Suzhou, China
Not specified
Tech transfer execution
Data integrity and compliance
Comparability study design
AstraZeneca is seeking an Associate Principal Scientist in Suzhou, China, to lead tech transfer execution and manage various aspects of process development in the cell and gene therapy sector. The ideal candidate will possess over eight years of experience, particularly in MSAT or process development, and have strong analytical skills, with a preference for those with experience in NDA/BLA submissions

Job Summary

  • Lead tech transfer execution by organizing the TT team, developing project plans, and driving risk management to ensure on-time, high-quality transfer.
  • Maintain data and document integrity and compliance, overseeing completeness, accuracy, and timely updates of technical data and documentation.
  • Own process validation strategy and execution, including studies for chromatography resin, reusable filters, mixing, cleaning, and yield.

Matching Summary

Match Score: 85

AstraZeneca is seeking an Associate Principal Scientist in Suzhou, China, to lead tech transfer execution and manage various aspects of process development in the cell and gene therapy sector. The ideal candidate will possess over eight years of experience, particularly in MSAT or process development, and have strong analytical skills, with a preference for those with experience in NDA/BLA submissions.

Skills & Requirements

Must-have

  • tech transfer execution
  • data integrity and compliance
  • comparability study design
  • advanced data analytics
  • process validation strategy
  • GMP audit participation

Nice-to-have

  • inclusive and diverse team
  • harnessing industry-leading skills
  • wide range of perspectives

Key Requirements

  • Master’s degree or above
  • More than 8 years’ experience
  • Experience with NDA/BLA submissions
  • Proficient in QbD, GMP
  • Strong statistical analysis skills
  • Strong written and fluent oral English

Work Rights

Not specified

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