OMB Meeting Book (March 2, 2017)

OMB Meeting Book

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Asia Pacific Technical Center, The Coca-Cola Company, Shanghai, China  Managed and led team to deliver accurate & prompt results on various tasks, emergency cases and projects  Guided team on method development, validation and transfer of safety related residual testing as well as quality control for various complex food matrix  Represented the company as technical expert at public media event  Led food safety related risk evaluation projects as well as ingredient risk screening projects to predict and mitigate future risk with advanced technology  Led and performed identification and structure elucidation for unknowns from complex matrix.  Tracked updates of global standards as well as domestic standards to ensure the promptness and integrity of analytical service; Responding to alerts from society and various agencies  Initiated projects and activities on new technology and concepts to achieve business development target of company as well as keeping the laboratory state-of-art capability  Identified resources, recruit manpower, budget to accommodate with desired analytical service work with high quality on time  Maintained expertise in the field of food quality and safety and analytical technologies; Developed team and coached talents; Assisted clients in result interpretation and offered technical advice  Built up documentation traceability system and data auto-backup system to ensure the integrity of quality system Sep.2008 - Aug.2011 Senior manager Pharmaceutical Development Service Center (PDSC), Shanghai Chempartner Co. Ltd. Shanghai  Set up a new GMP analytical lab with quality control and continuously improve quality system in compliance with cGMP, FDA compliance regulations. Leading professional team to pass numerous audits from various clients from US, Europe and Asia  Organized and supervise a cGMP team to provide cutting-edge analytical service and technical support in compliance with cGMP, FDA guideline and ICH guideline  Building up a complete set of SOPs to direct daily activities and common practice in the analytical center conforming cGMP, FDA guideline and ICH guideline  Planned, managed and supervised all scientific and technical activities of analytical service group.  Led and guided analytical method development, method validation, method transfer of LC method for impurity, assay and dissolution; GC method for impurity, assay and residual solvents , GC/MS, LC/MS, IC for counter ion and residual impurity, GFAA for metal analysis for both API and finished drug product  Drafted, reviewed and approved protocols of method development, method validation protocols and method transfer protocols under cGMP, ICH and FDA guidelines  Drafted, reviewed and approved method development reports, method validation reports and method transfer reports; Reviewing and approving Certificate of Analysis (CoA) and Result of Analysis (RoA)  Lead and guided structural characterization/elucidation of impurities and degradation, impurity profiling and stability testing  Lead analytical development and documentation for IND filing to FDA and CFDA; Delivered two projects for IND filing to CFDA  Trained scientists on technical skills and cGMP operation; and initiate personal development plan for team members; Setting up workshop to train scientists and technicians to adapt new leading technologies and regulation  Lead dedicated scientists to actively undertake challenging projects and produce quality deliverables within good timing and budget  Actively participated technical clarification and business communication with customers Jan. 2005 - August 2008 Research Fellow

March 2, 2017