Description
Execute downstream process development for biologics such as monoclonal antibodies, and support technology transfer activities to internal and external manufacturing sites for early- and late-phase projects.
・Establish appropriate control strategies for IND/BLA submissions and support the maintenance of commercial manufacturing to ensure a stable supply with consistent quality within project teams.
・Evaluate the introduction of innovative technologies in downstream processing in collaboration with internal and external partners.
・Participate in meetings with CDMOs and internal stakeholders across different time zones as a representative or member of the technical team.
・May serve as Drug Substance Lead in biologics projects, designing and executing project CMC development strategies, driving planning and operational excellence, and ensuring seamless collaboration across CMC functions.
Qualifications
Highest qualification: University
・Experience in downstream process development for biologics.
・Master’s degree and experience in the pharmaceutical or biotechnology industry.
・Basic business communication skills in English.
・Cross-functional collaboration skills.
・Problem-solving capabilities and a proactive, hands-on mindset.