Analyze quality and compliance within QC Laboratories to ensure adherence to global standards and regulatory requirements, collaborating across teams to support product testing and investigations, driving improvement, and preparing for audits.
Drive key internal audit initiatives, ensuring effective SOX compliance and enhancing operational excellence through thorough audits and risk assessments. Collaborate with stakeholders to assess controls, document findings, and implement improvements.
Transform early process development in viral vector production by leading scalable upstream strategies. Leverage molecular biology and bioprocess expertise to optimize lentiviral vector processes for in-vivo CAR-T applications, ensuring manufacturability.
Elevate production quality and efficiency in a fast-paced, compliant environment by managing cell therapy operations and fostering teamwork. Lead 2nd shift personnel and ensure adherence to cGMP standards while driving continuous improvement initiatives.
Champion the manufacturing process within a dynamic CAR-T team, ensuring compliance and efficiency in a cGMP environment. Lead operations, support personnel development, and drive continuous improvements in personalized cell therapy production.