( Associate) Principle Scientist – CAR-T Full-time NEW

Job Title

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 submissions of cell and gene therapy industry is preferred.

Proficient in QbD, GMP and other related regulations/guidance.

Strong statistical analysis skills.

Strong written English and fluent oral English.