Provide technical and on-floor support for the commercialization, manufacture, and lifecycle management of monoclonal antibody products.

Collaborate with R&D, Manufacturing, and Quality teams to execute technical studies, validation activities, and technology transfer programs.

Support manufacturing teams with real-time troubleshooting and participate in investigations, including root cause analysis of deviations, complaints, and OOS/OOE events. Ensure proper documentation, CAPA development, and resolution within quality systems.

Act as a subject matter expert for product and process within cross-functional teams, projects, and governance forums.

Utilize scientific and statistical tools to improve process understanding, maintain process control, and identify opportunities for optimization and continuous improvement.

Lead and execute projects to address process perform...