Senior Scientist, Gene Vector Process Development

About the role

AstraZeneca is hiring a Senior Scientist for its Gene Vector Process Development team in Shanghai. The role drives robust upstream process workflows for plasmid DNA and viral vector manufacturing, using expertise in E. coli fermentation, mammalian cell culture and design of experiments.

Key responsibilities

• Develop and run experiments to build robust upstream workflows, analyze data and recommend process improvements
• Apply E. coli fermentation, mammalian cell culture, multivariate DoE and in-process analytics to design, scale up and optimize processes while minimizing impurities
• Evaluate new technologies and innovations to improve process performance, enable predictive modeling and strengthen process control
• Support technical investigations through equipment troubleshooting and testing
• Analyze, document and present experimental data to internal teams and stakeholders
• Work with cross-functional stakeholders to keep programs on track and transfer processes to manufacturing teams, with documentation, training and support
• Maintain accurate, compliant records (databases, batch records, ELNs) and author and review SOPs, batch records, process development and transfer reports, and support regulatory submission documentation

Required profile

• M.S. or above in Biology, Biotechnology, Microbiology, Biochemical Engineering or an equivalent field; more extensive experience considered for a senior scientist position
• At least 3 years of hands-on upstream process development in biopharma or biotech, including manufacturing, pilot-scale and/or laboratory-scale environments
• Direct experience in upstream operations, including scalable suspension processes for plasmid DNA and/or viral vector products
• Experience in plasmid DNA production and scale-up bioreactor operation is a must
• Ability to coach and mentor junior scientists, solve problems independently and communicate verbally and in writing

Required skills

• Upstream batch/fed-batch process development, bioreactor operation and scale-up/scale-down modeling
• Proficiency with statistical analysis software (JMP, MODDE, Minitab) highly desired
• Attention to detail in protocols, SOPs, batch records and technology transfer documents
• Collaboration across cross-functional teams