Major responsibilities

• Engage in tech transfer business, such as preparation of TTP, gap analysis, knowledge transfer and training, to proceed the project as schedule.
• Ensure the integrity of tech data and documentations, and timely update as required.
• Conduct the process related investigation, optimization and scale-up study.
• Handle the tech related troubleshooting, deviations, change and CAPA during manufacture business.
• Participate in the related validation studies, including chromatography resin, reusable filter member lifetime validation, mixing study, cleaning study and yield study et al.
• Attend in GMP audits, regulatory filing as required.

Education, Qualifications, Skills and Experience

• Master’s degree or above on biological or pharmaceutical relevant major. Graduates from 211/985 Project universities and those with overseas work experience are preferred.
• More than 3 years’ experience in MSAT or process development, with the experience of BLA or cell and gene therapy industry preferred.
• Be familiar with QbD, GMP and other related regulations/guidance.
• Good statistical analysis capacity.
• Good written English and fluent oral English.

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.