Singapore
7 years of experience in the pharmaceutical industry (from start up to process development to GMP). Key member in start-up projects for 2 biologics manufacturing facilities with 20,000L capacity. Excellent teamwork and communication skills Possess good leadership skills and can deliver under tight schedules
• Over-all in charge for manual cleaning validation of small parts used in LBXS facility • Perform risk assessments for new parts, validating the clean-ability of high risk parts through mock soil and cleaning • Subject matter expert for clean hold and SIP of automated system • Develop validation approach for new equipment CIP / SIP and clean hold • Involve in walkdown of new systems to determine sampling points, preparation and execution of validation protocols • Prepare and execute validation protocols • Author validation summary reports for successful runs completed in the facility • In house trainer for various activities (plant gowning procedures and visual inspection) • Consultant for different departments during troubleshooting and investigation to resolve issues • Support internal / external audit, includes the preparation of powerpoint slides and other documentation
• Shift lead (Team of 8 Biotechnologists) for the mammalian cell culture operations LBXS-2 facility • Oversee the tasks performed during day to day operations • Proficient in troubleshooting and solving problems when they arise • Key trainer for bioreactor operations, media preparation operations and harvest operations • Liaised with other departments (Engineering and Calibration) to schedule maintenance work for equipment • Work with Deviation Investigation Team and Quality Assurance to support deviation investigations, close up of documentation, quality and process issues
• Commissioning and Validation team leader (Team of 4 Biotechnologists) for the LBXS-2 facility • Key Team to complete the qualification for the team SIP of the equipment in LBXS-2 facility Fermentation suite (which includes 4 x 20,000L bioreactors, harvest tank and the depth filtration system) • Determine the required SOPs for the mammalian cell culture operations LBXS-2 facility • In charge of procurement (tools and small equipment) for use in manufacturing LBXS-2 facility • GMP commissioning lead for the Harvest suite (Consisting of Alfa Laval disc stack centrifuge, depth filtration system and the harvest tank) • Review the harvest operation batch records • Main trainer for the harvest operations • Shift Lead (Team of 8 Biotechnologists) for the mammalian cell culture operations LBXS-2 facility