Ji Ma Email and Phone Number

Joint in the SUT cell and lead the Kaizen and VSM improvement.Participated in the Media culture transfer project as the PMO of catch side.Lead the oligo expansion project as the PM.

• Directly manage equipment commissioning and qualification equipment qualification teams, including hardware validation and software validation.• Manage and allocate resources responsible for teams performing validation activities of new equipment and computerized systems and/or changes to existing equipment and standalone computerized systems.• Ensure resources performing validation activities are knowledgeable of and in tune with the latest industry regulations and initiatives.• Contribute to the leadership and direction of the Project Planning group in support of the team’s overall objectives.• Set appropriate objectives and priorities and deliver results within project timelines while maintaining an effective network across Manufacturing, Manufacturing Support, Process Development, Quality Assurance, Analytical, and biological.• Apply Continuous Improvement and Lean tools to consistently improve performance and reduce deviations according to the Six Sigma standard.• Performs GMP walkthrough inspections to ensure compliance with cGMP and regulatory requirements• participates in site inspections/audits by facilitating discussions with inspectors/auditors, fulfilling requests for information, and presenting to inspectors on required topics

• Executes equipment qualifications, validation protocols, and process improvement studies of doxorubicin liposomal formulation compounding and filling • Develops and composes equipment and process standards operating procedures (SOP), and training materials• Provide operation and maintenance training to junior operators and engineers• Conducts investigations into mechanical and qualification failures and develops and implements remediation plans for continuous improving of the Doxorubincin Liposome project, including compounding and filling • Contacts with and supervises vendors for qualification and metrology functions.• Develops, review and approves written procedures for calibration and preventive maintenance of equipment• Support technology transfer, scale-up, media fill, pilot batches and FDA batches• Develop and compose change controls, deviations, CAPAs

• Develop, compose, review, and approve validation master plan and matrix, validation and qualification protocols, associated reports, and procedures.• Conducts qualifications, validations, compose relative reports • Develop, compose, conduct and approve SAT, IQ, OQ, PQ validation, periodic revalidation of the washing machine, depyrogenation tunnel, filling and stoppering machine, capping machine, external washing machine, isolator, autoclave, and parts washer according to ICH, PDA, GMP, and GEP guidance.• Perform Environment monitoring and investigation

• Monitor, clean, and sanitize the production environment of ISO class A, class C, and class D, which belong to filling line isolators and autoclave isolator• Operate and monitor pharmaceutical equipment including isolator technology, parts washer, autoclave, vial washers, depyrogenation tunnels, filling and stoppering machine, capping machine, external washing machine, etc.• Assures and completes detailed documentation that is a correct and accurate record according to GDP requirement.

Case 1. Hong Kong• An analysis was made at the end of the year 2015 when the riot broke out in Hong Kong. • Based on the historical factors, the reasons of the riot were identified, which are predatory of real estate tycoons, the unbalanced public utilities and welfares, the effects of immigrates, cultural conflicts, and economic slowdown.• The road map of future development was composed, including the amalgamate of Pearl River Delta development, the self-positioning of Hong Kong in one belt one road national plan, real estate policy reform, education, cultural exchange, and democratic construction. • the paper above which directly sent to the CEO’s office was accepted and submitted to the higher authority. The most of suggestion was applied. With the efforts of officers of Hong Kong government, the house price decreased, underemployed population decreased 2 presents, the public dissatisfaction was moderated, and overall condition of Hong Kong was getting better.Case 2. 2016 U.S. presidency • An analysis about president Donald Trump and his possible policies in the future was made on Dec 1, 2016.• By analyzing the historical record of president Trump, his psychological and behavior profiling were made. Accordingly, the diplomatic and economic policies in the next five years were predicted based on public information. All the predictions turn out to be accurate.• An analysis about China’s economy and the roadmap of economic reform depends on the prediction of U.S. policy were also given, which includes tax reduction, government information disclosure and private information protection, administrative structure optimization, incoming population crisis, invisible poverty, and inter-regional coordination of economic development.• The Chinese version is available at http://solorchis.blogspot.com/2018/07/thursday-dec-1-2016.html.

• Design, build and explore new experimental methods and equipment to understand and investigate the phenomenon of fluid of a complex asymmetric angle-mounted axial impellers system for a top pharmaceutical company• Use computational simulation (i.e. CFD) and laser experiment (i.e. PIV) to compare the data of both to determine the critical parameters to improve the manufacturing process of a scale-up device and process according to the demand of cGMP and the regulations of FDA • Design and conduct laboratory to scale-up batches for pharmaceutical products and process development• Organize and manage the laboratory instruments based on the SOP protocol under GLP• Coordinate with pharmaceutical companies based on research projects for execution of scale-up and meet the project requirements• Achievement: Determine the critical parameters, and the process of manufacturing related to pharmaceutical industry to improve the quality of the drug product using both computational analysis and experimental approach, PIV measurement, on flow fields in stirred vessel with double A310 impellers tilted at an angle of five degrees

• A position provided by a food company, whose scope is manufacturing its own products and expanding local market for large seasoning manufacturers such as Foshan Haitian and Totole. • Assisted the CEO to manage logistics and accounting, coordinated the distribution with clients and suppliers, and delivered goods to local dealers. • Achievement: By analyzing the business and manufacturing processes with enterprise resource planning (ERP) methods, I analyzed the data and promoted the production process and inventory turnover to reduce the cost and to assist decision making of CEO. The overall cost was cut by 10 presents.mates.