OMB Meeting Book (March 2, 2017)

40 / 108

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
OMB Meeting Book 35
March 2, 2017