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 integrality of process materials 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. Have good statistical analysis capacity. Good command of 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 authorization and employment eligibility verification requirements.
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world's most serious diseases. But we are more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We're curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We're driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you'll do work that has the potential to change your life and improve countless others. And, together with your team, you'll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.
Tagged as: Life Sciences
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