Required Skills: Biologics, Deviation Management, DP Operations, Facility Design, GMP Compliance, Manufacturing, Manufacturing Operations, Manufacturing Process Validation, Project Management, Regulatory Compliance, Sterile Manufacturing, Technical Transfer, Working Independently, Writing Technical Documents. Responsible for technical activities for the commercial manufacturing process at the external partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.