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.