李军 李

◆ Take care of manufacturing of products within specified quality, quantity and timeline considering all relevant GMP, safety, ecological and economical aspects ◆ Ensure that products are produced in a manner compliant with quality, EHS and regulatory requirements together with quality management, EHS and regulatory affairs ◆ Write qualification protocols and reports and perform the qualification of manufacturing equipment ◆ Maintain and optimize chemical processes (engineering and technical wise) ◆ Perform Risk Analysis and Assessment before production ◆ Make sure that production staff is trained in project related matters ◆ Support and point of contact for project team members from development ◆ Writing of monthly reports and GMP-relevant SOPs in production in collaboration with production manager ◆ Make sure in collaboration with production manager that equipment is GMP-compliant ◆ Make sure that all needed GMP-documents are compliant with internal and external regulations

◆ Introduce and transfer new products and processes from Novartis global plants or R&D laboratory to Novartis plant in Suzhou. ◆ Maintain an overall understanding of current process and its production status, and carry out tests for technical support and necessary technical innovation as well. Responsible for the technical management of chemical processes. ◆ Lead OOS and deviation investigations related with the product and process under supervision, then identify the root cause of the problems and take corrective and preventive measures to avoid recurrence of similar problems. Resolve any process issues arising on the site in a timely manner. ◆ Prepare or review the relevant SOPs and critical technical documents and reports, including the manufacturing batch records, cleaning batch records, process validation reports, campaign reports and risk analysis, etc. ◆ Responsible for transfer and implementation of new products and new processes to production including validation. Responsible for process safety, e.g. risk assessment and implementation of safety measures in close collaboration with HSE. Responsible for implementing the necessary measures to protect the environment and reduce waste generation. ◆ Served as a part-time process manager in tank farm once upon a time, maintain the existing solvent recovery processes using distillation column and handle the introduction of new solvent recovery projects. ◆ Responsible for correct data of production in electronic systems, e.g. BoMs and Recipes in SAP. ◆ Maintain and adhere to cGMP and HSE requirements for corresponding processes to ensure the compliance and safety. ◆ Support the Process Unit Head and coach production people in the organization, collaborate closely with operation, process engineer and QA etc. ◆ Join the Novartis global GMP compliance audit and FDA audit as a subject matter expert in Suzhou Novartis. ◆ Participate in supplier audits to ensure the long term stable supply of qualified raw materials.

◆ Responsible for the laboratory studies, kilo-lab synthesis and pilot plant scale-up of active pharmaceutical ingredient (API). ◆ Conduct process development and optimization of API in accordance with the requirements of GMP. Apply the principles and techniques of process chemistry to determine the optimum parameters and operation range of the production process. Perform process control strictly and transfer the process to plant production. Three projects of API were developed and transferred to plant production successfully. ◆ Develop process of generic drugs in accordance with the requirements of clients and GMP to produce qualified API. ◆ Employ statistical tool of Minitab and Design of Experiments (DoE) to obtain the optimum experimental conditions. ◆ Receive project management training and six sigma training, and apply methods of project management and six sigma to improve the level and efficiency of R&D activities.