Jan.2019 - Now: Process Engineer ( MSAT, Upstream)

Process Engineer experience  Technology Transfer:  Support the timely and successful transfer of the customer’s manufacturing process(es).  Upstream Process Support:  Support/lead the preparation, execution, process monitoring and post-campaign activities. Monitor processes on a regular basis to have further understanding of process behavior and prospectively identify process issues.  Provide floor and on-call support during production. Escalate issues to management appropriately and interface with customer on issue resolution as required.  Support investigations into process trends, issues or deviations.  Write change requests and drive to implementation.  Review manufacturing batch records and provide technical inputs to MFG technical document writing specialists.  Identify training needs and provide training materials for MFG operators on process batch records. Work with MFG to update process batch records to enable robust manufacturing operations.  Perform / support small-scale experiments / studies in lab to support technology transfer or investigations. Follow all applicable lab safety policies.  Support preparation of Annual Product Review (APR) and Continued Process Verification (CPV) summary reports, perform work-stages to support customer BLA filing.  Maintain process databases and monitor batch to batch consistency of operations.  Support inspections and audits by customer and regulatory authorities  Key Achievements:  Supported multiple big scale upstream commercial processes from various biopharma customers (Roche, Abbvie)  Supported technology transfer for commercial and clinical phase processes  Involvement in process improvement projects focusing on cost/time reduction, titre improvement and small/lab scale studies

2017-2019

Local Biologics Program Trainee