徐镇安 徐

• Responsible for CMC management, technology transfer and process validation execution, including preparation, internal plan preparation, risk assessment, reports, qualification protocols, process justification reports technology transfer reports etc.,. Responsible for project management and delivery and enhance team leadership. • Budget management, cost calculation and quotation. Support Plant design(project investment, BEP & NOI analysis, financial profitability analysis) , team management and optimize key process and policy. • Assess process fit, process safety, productivity is matched with demand. Perform equipment selection, material management. Responsible for smooth scale up by meeting desired quality. And also ensure the cGMP practices and safety. • Identifying opportunities and solve them to stakeholder satisfaction by include throughput improvement, productivity improvement, overall plant effectiveness improvement, quality, yield improvement. • Providing support for regulatory inspections, vendor & customer GMP audits. Review Supply and Quality agreements. Work Achievement: • Provide TO technical support for new plant(investment 3 billion RMB, construction area 150,000 m2 ). • Lead TO team to build the product transfer & CMC project management system & quotation for more than 100 projects, enhance team leadership; delivered more than 50 CMC projects milestones. 全面负责CMC项目的管理，包括组织研发技术团队进行工艺转移、技术转移和工艺验证的实施。包括技术转移项目的准备， 内部计划准备、风险评估、报告、确认方案、工艺论证报告、技术转移报告等。领导项目团队顺利交付产品。 • 编制预算及项目成本核算和报价。支持新工厂规划设计，包括立项投资可行性研究，盈亏平衡和投资回收分析，财务获 利能力分析等。团队管理和健全关键业务流程及各项制度。 • 评估工艺的可行性，工艺的安全性，生产能力是否与需求相匹配,进行设备选型，物料管理。负责在质量满足要求前提下 顺利放大。确保cGMP的实施和安全。 • 为提高生产效率、产量和质量提供技术支持。分析生产工艺，消除现有产品的工艺问题。技术支持以满足法定要求。 • 为法规及cGMP检查，供应商和客户审计提供支持，并成功通过cGMP认证。审阅供应协议和质量协议。 工作&项目业绩： • 领导技术运营团队对新工厂设计和投产提供技术支持（总投资30亿元，建筑面积15万平方米生产基地）。 • 领导技术运营团队建立了CMC技术转移和项目管理体系。提升项目管理团队领导力，并积极开展对外技术交流合作。 • 领导团队完成了100多个客户项目的项目成本核算和报价。 • 领导团队达成50多个CMC项目研发工艺生产放大工作里程碑。

Serve as single point of contact for clients to manage Pre-clinical developability research, solid state & formulation development, IND phase development (early stage), formulation development (late stage), NDA, launch & commercialization, ANDA project. Prepare quotations/proposals and establish CMC project timelines and deliverables. Cross-function team management, and organize technical & CMC RA team to align CMC drug development and registration strategy. Leading project progress and delivery, report to internal and external stakeholders. Profiling(LogP,pKa), physical form(polymorph,salt/crystal) screening, DMPK & bridging, feasibility study, compatibility study, etc. Early & late stage DoE study,QTPP,CQA,CPP establishment, process optimization and scale up, initial stability study.(OSD&Injection) Lab scale formulation & process optimization and evaluation, analytical method development and pre-validation.Pilot scale production strategy and execution, technical transfer and stability study.NDA registration batch and commercial batch scale strategy and execution, PPQ & CV, AMV, trouble shooting. Filing management: preparing CMC documents for IND & NDA filing. Work Achievement: Delivered more than 10 CMC projects milestones (IND & NDA) Organize late phase team to optimize operation system throughout Pre-formulation, IND, CTM, TT&DoE, NDA,PPQ, PAI,etc. CMC项目管理-作为客户SPOC管理 临床前研究，制剂处方前可开发性研究阶段，制剂固态开发阶段，临床制剂早期研发阶段，制剂后期研发阶段，注册申报与上市商业化阶段等，以及其他仿制药项目。 负责项目报价与合同签订。建立CMC项目时间表和交付成果。跨部门管理项目团队并交付项目。组织技术团队和CMC RA团队，制定CMC药学研发策略和注册申报策略。主导项目进程并及时汇报给内外部受益方。 药学物理表征研究（LogP，pKa），固态晶型盐型筛选，PK研究和桥接，临床前可行性研究，相容性研究，粉体学研究。 早期&后期制剂开发DoE实验设计，QTPP，CQA和CPP建立，工艺优化和放大，初步稳定性批次实验。 小试阶段处方工艺优化和评价，分析方法开发和预实验。中试工艺放大策略制定和执行，技术转移和稳定性批次研究。 上市申报注册批次和商业化批量工艺验证，清洁验证，分析方法验证，技术难题解决。 CMC申报管理（IND & NDA），申报资料撰写（CMC）和申报准备。 工作业绩： 领导技术团队完成10多个CMC项目（IND & NDA ）的相关里程碑 组织CMC workshop建立和完善了项目体系（处方前研究，临床申报，临床供应，TT&DoE，工程批，注册批，PPQ，PAI）。

技术转移经理 Technology Transfer Manager| 科学制造与技术部 诺华制药 工作描述： Responsible for technology transfer activities at site level, including transfer in and out and any scale-up. Leads technical transfer project team at site and liaises efficiently with involved functions (e.g. Development, Supply Chain, Production Unit, Quality Control, HSE, other sites.). Product Life cycle management within supply chain management. Manages technical activities on site level for product transfers (process, technology, analytics, capacity, resources).Provides technical expertise together with site experts. Defines and monitors project scope, timing and progress. Initiates change control in system and ensures approval and closure. Ensures that all activities are performed to current standards (current Good Manufacturing Practices cGMP, Health Safety Environment HSE, Regulatory etc.). Manages technology transfers for scale-up, at site level. Supports continuous process and quality improvements. Ensures inspection (Pre Approval Inspection PAI) readiness. Award: Asia Pasific special award(Entresto product launch team); Above award( Galvus Transfer) 负责工厂技术转移活动，包括转入，转出及任何的放大。 领导技术转移小组，有效协调工厂各个部门（如：开发部门，物流供应链部门， 生产部门， 质量控制部门，HSE部门，其它工厂）进行技术转移。 整合供应链职能进行产品生命周期管理。 管理工厂产品转移的技术活动（工艺，技术，分析，能力，资源） 和工厂专家一起提供专业技术 定义和监督项目范围，时间，和进度 起草变更控制确保批准和关闭 撰写生产过程转移文件（包括方案和报告） 协调工厂试制批，法规批和验证批的进行 发起并监督持续工艺确认 确保所有活动符合当前标准（cGMP, HSE, 法规等） 管理工厂技术转移的放大 支持持续工艺和质量改进 确保批准前检查的准备就绪 获奖情况：诺华技术营运亚太区特别奖（诺欣妥产品上市项目）；杰出贡献奖（佳维乐产品转移） 主要业绩： 项目描述：负责工厂技术转移活动，包括转入，转出及任何的放大。 领导技术转移小组，有效协调工厂各个部门（如：开发部门，物流供应链部门， 生产部门， 质量控制部门，HSE部门，其它工厂）进行技术转移。 整合供应链职能进行产品生命周期管理。 项目职责：领导技术转移小组，进行技术转移活动 项目业绩：在项目schedule预期内，顺利并提前完成了新产品上市和技术转移工作

技术转移专家 Technical Transfer| 技术部 阿斯利康 工作描述： Formulation Project: Technical Transfer-Technical Opportunity Risk Assessment Validation Master Plan/Process Validation/Cleaning Validation Plendil(Phase II) /Crestor(phase III) Leading the process equipment PQ/PV on the phase II plendil process (HSM/Oven/Blending/Coater)--Technical Transfer of Plendil Leading Crestor Pre-blending process equipment change Leading Coater (Phase II/III) process optimization Takeover phase II/III from global engineering/third party as the process SME Process Robustness program(Continuous process verification) implementation on Betaloc 25mg of routine monitoring (data collection/review/RCAs) toward an robust process. Packing Project: Technical Transfer of Crestor Packing PVC switch plan for Betaloc--Stability study Dossier preparation.Artwork and PKG material specification management Packaging lines IQ/OQ/PQ for process equipment/E-coding project support Award: VP special award(Phase I contribution);AZ culture award;Lean continuous improvment award(Plendil packing new design);Q excellence team award 制剂项目： 技术转移-主持技术机遇风险评估、验证主计划、工艺验证、清洁验证等-（二期）和可定（三期）:波依定-制粒/烘房/混合/压片/包衣 ；可定-配料/API预混/混合/压片/包衣 领导可定（三期）预混工艺设备改造工作 领导包衣（二期、三期）工艺改进项目 从全球工程部/第三方接收二期项目（作为技术专家），并领导二期波依定产品技术转移PQPV工作 领导倍他乐克工艺稳健性项目（持续性工艺验证Continuous process verification）并主持FMEA相关活动 包装项目： 领导可定分包装技术转移 倍他乐克内包材切换项目 PVC-switch 稳定性研究 Artwork和印刷包材管理 领导一期项目阶段包装线验证工作（SAT/IQ/OQ/PQ) 参与电子监管码项目并制定电子监管码系统管理流程 包装材料供应商及质量标准管理 获奖情况： 总裁特别奖（一期项目贡献奖），阿斯利康文化大使奖，精益持续进步奖（波依定包衣工艺优化和波依定新包装设计），质量团队卓越奖

Ensure the operation system of production and packaging accord with GMP, the law for medicine management and company internal requirements.Ensure timely completion of the production plan both in quality and quantity. Increase the first time rate according to effective on-site management, staff training and utilizing CAPA system, decrease the complaint rate and accident relevant to production quality. Strive to increase the correct rate of documents.Give training to workers about SOPs, GMP and technique to make them qualified. Support the validation work of equipment PQ, product PV and CV. Review documents relevant to production, such as URS, BXR, PMF, SOP, etc. Support Quality and Purchasing departments to improve the quality of manufacturing material. Support Engineering department to maintain the regular operation of equipments.Resolve the abnormal issues of raw material, facilities, technology and environment during production.Continuonsly optimize production process and improve capacity of facilities to reduce production cost. Communicate with planning to confirm operator shift work. Issue deviation and material complaint reports; support the investigation of CAPA, abnormal issues, and material defects. On-site inspection and supervision during production process. Shift work management：Responsible for general coordination in shift work, ensure the shift performance dialogue carry out effectively. CHINA LEAN implementation：To get sustained improvement for equipment efficiency, operator efficiency and product yield, be fully involved in CHINA LEAN implementation, optimize production process, reduce non-value added step, to shorten production throughput time.