·Technology Transfer: Lead the timely and successful transfer of the purification stages of the customer’s manufacturing process(es) into the Lonza Singapore production facility. Work with other MSAT team members, technical experts from Lonza’s customer companies or Lonza donor sites, Manufacturing (MFG), Quality Assurance (QA), Quality Control (QC), and other departments on the technology transfer.
·Process Support: Lead the preparation, execution, process monitoring and post-campaign activities for purification stages of the customer’s manufacturing processes at Lonza Singapore production facility. Become proficient with processes in the facility and develop ability to support/lead activities across multiple processes. Monitor processes on a regular basis to have further understanding of process behavior and prospectively identify process issues. Develop ability to generalize issues across processes.
·Lead investigations into process trends, issues or deviations involving multiple departments and customers.
·Write change requests and drive to implementation.
·Design and perform/support small-scale experiments/studies in lab to support technology transfer or investigations.
·Identify training needs and provide training materials for MFG operators on purification process batch records. Work with MFG to update process batch records to enable robust manufacturing operations.
·Support inspections and audits by customer and regulatory authorities.