MSAT (Associate)Principle Scientist

Major responsibilities

• Lead tech transfer execution: organize the TT team, develop and manage the project plan with clear milestones, and drive risk and crisis management to ensure on-time, high‑quality transfer.
• Maintain data and document Brake: ensure integrity and compliance, oversee the completeness, accuracy, and timely update of technical data and documentation per requirements.
• Drive comparability study: design and execute comparability studies for critical changes (e.g., site addition, critical material or process changes, production line expansion).
• Perform advanced data analytics: conduct deep, statistically sound analyses to generate insights and inform decisions across development and manufacturing.
• Design and execute process related investigations, optimizations, and scale‑up studies to improve robustness, yield, and manufacturability as required.
• Resolve manufacturing issues: facilitate timely closure of technical troubleshooting, deviations, changes, and CAPAs, ensuring effective root cause analysis and preventive actions.
• Own process validation strategy and execution: design and implement validation studies, including chromatography resin and reusable filter lifetime, mixing, cleaning, and yield studies.
• Support compliance and regulatory activities: participate in GMP audits, on-site inspection, and regulatory filing as required.

Education, Qualifications, Skills and Experience

• Master’s degree or above in biological or pharmaceutical discipline. Graduates from 211/985 Project universities and candidates with overseas work experience are preferred.
• More than 8 years’ experience in MSAT or process development. Experience with NDA/BLA submissionsof cell and gene therapy industry is preferred.
• Proficient in QbD, GMP and other related regulations/guidance.
• Strong statistical analysis skills.
• Strongwritten English and fluent oral English.

AstraZeneca 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 authorisation and employment eligibility verification requirements.