Senior MSAT Engineer (Downstream)
The Senior MSAT Engineer (Downstream) at Kyowa Kirin North America plays a pivotal role in the Manufacturing Science and Technology (MSAT) team, focusing on downstream processes within a dynamic biopharmaceutical environment. The position is based within a company renowned for its commitment to innovative therapies and improving patient outcomes. In close collaboration with cross-functional teams, the Senior MSAT Engineer ensures seamless scale-up and tech transfer of robust, compliant manufacturing processes for biologics.
Key responsibilities include supporting commercial and clinical manufacturing by monitoring, troubleshooting, and optimizing downstream purification processes. The role involves providing technical expertise for process validations, implementing process improvements, and supporting investigations related to production deviations. Day-to-day work often requires working with data analytics, preparing technical reports, and interfacing with quality, regulatory, and process development teams to ensure operational excellence and regulatory compliance.
Ideal candidates bring a bachelor’s, master’s, or PhD in chemical engineering, biochemical engineering, or a related discipline, along with several years of hands-on experience in downstream bioprocessing, buffer/media preparation, and production-scale purification systems. Strong analytical skills, proficiency with technical documentation, and a proven track record in leading or supporting tech transfers are essential. Experience with regulatory filings (such as IND, BLA) and familiarity with cGMP environments are highly valued.
Kyowa Kirin North America offers comprehensive benefits, including health insurance, retirement plans, paid time off, and opportunities for professional development. The company supports a collaborative culture that values scientific innovation, continuous improvement, and employee growth, making it an attractive environment for driven engineering professionals seeking to advance their careers in biotechnology.