MSAT Director, Xi'an Site

职位概述 POSITION SUMMARY :       

制造科学与技术部总监负责制造科学与技术部团队整体事务，重点关注以下方面工作：

The Manufacturing Science & Technology Director manages a Manufacturing Science & Technology (MSAT) team with the dedicated focus on:

1. 新产品引进/产品生命周期管理 – 工厂技术转移协调工作 NPI/LCM- Technology transfer coordination at site
2. 性能确认、验证活动的实施（工艺和清洁验证） PQ, Validation execution (Process and Cleaning Validation)
3. 工艺改进活动的实施 Process improvements execution
4. 标准的发布执行，PAT工艺分析技术，新技术的应用 Standards deployment, PAT, new technology application

制造科学与技术部总监虚线向工厂长汇报，实线向MSAT技术平台负责人汇报。工厂MSAT负责人需管理一支由研究员和工程师（清洁\工艺\包装验证专家、技术工程师和项目经理等）组成的跨部门职责协作的团队，负责验证主计划和相关的性能确认、工艺和清洁验证的管理；作为验证和性能确认的系统负责人，对其职责范围内的法规检查负责。

The Manufacturing Science & Technology Director/Senior Manager will report dotted line to the Site General Manager and solid line to the MSAT Platform Lead. The Site Manufacturing Science & Technology Lead will lead a team of Scientists and Engineers (Cleaning / Process / Packaging Validation Experts, Advanced Technology and Project Managers) across the Site Business Units. Being accountable for the Validation Master plan and execution of related Process Performance Qualification and Cleaning Validation. Being System Owner of Validation and PQ and therefore accountable for Regulatory Inspection for area of responsibility.

制造科学与技术部总监需负责日常的性能确认和验证管理以及相关的项目执行，包括支持新产品引进或生命周期管理行动方案。制造科学与技术部总监同时应负责标准的执行和工厂经营成果的信息传递。

The Manufacturing Science & Technology Director is responsible for day-to-day PQ & Validation Management as well as related Project Execution, including supporting NPI or Life Cycle Management initiatives. The Manufacturing Science & Technology Director is responsible for the execution of standards and delivery of business results on site.

管理工厂产品转移 / 产品引进 Manage Product Transfer /Product Introduction for the Site:

• 确定项目范围，明确项目目标和成功标准；

Define the project Scope, Objectives and Success Criteria;

• 完成技术评估；Perform the Technical Assessment;
• 制订项目战略/计划；Develop Project Strategy/Plan;
• 建立项目团队并明确与技术运营全球各职能部门、工程部及生产部的联络人；

Develop the team and define Interfaces with Manufacturing Science & Technology Global Functions, Engineering and Operations;

• 设备性能确认；Equipment performance Qualification;
• 工艺转移、特征批及确认批（包括清洁验证）；

Process Transfer, Characterization and Verification (including Cleaning);

• 项目评估、总结及移交；Project Evaluation, conclusions and hand-over;

技术和产品技术生命周期管理 Technology & product technical life cycle management:

• 与产品流负责人、工厂长及业务部门就项目优先级进行合作；

Partnering with Product Stream Lead, site GM and BUs on project priorities;

• 就指定的项目以及日常调查研究和上报事件，与工程部及生产部进行合作；

Partnering with Engineering and Production on oversight of projects assigned as well as day to day investigations, escalations;

• 结合技术与标准化流程达成用户需求及发布技术；

Partnering with Technology and Standardization stream on URS and technology deployment;

• 管理工厂验证主计划；Manage the Validation Master Plan of the site;
• 监测工艺过程及产品性能；Monitor technical process and product performance;
• 管理或支持复杂的工艺调查（质量不符合及上报事件）；

Lead or support complex failure investigations (escalation of quality or compliance events);

• 管理特征批，工艺验证，包装验证，清洁验证，产品生命周期的验证，工艺调查以及支持产品的注册和现场核查；

Manage characterization batches and lifecycle validation activities including process, packaging and cleaning validations as well as CPV, re-validation, investigations and on-site inspections, regulatory filing of related products;

• 关键工艺参数的管理；Recipe management for process critical parameters;
• 电子批记录中工艺部分的管理；Process related inputs in EBR;

创新 & 标准化 Innovation & Standardization ：

• 评估新技术的使用，如工艺分析技术；Evaluate use new technologies such as PAT;
• 促成制造科学与技术部标准化方案的生成；

Contribute to Standardization initiatives for Manufacturing Science & Technology;

相关审计和执行 Inspection Readiness and Execution ：

• 领导工厂验证主计划的编写；Accountable for the Site Validation Master Plan;
• 在技术层面支持质量部的各种法规审计和检查；

Technical support in partnership with Quality on any regulatory audits and inspections.

• 内部和外部审计的发言人；Being the Spokesperson in internal and external audits.

50%

组织领导力 ORGANIZATIONAL LEADERSHIP:

• 根据杨森供应链的商业目标（预算、资源等），保持与工厂及制造科学与技术部的商业优先级一致来管理团队；

Accountable for managing team in accordance to the Site and Global Manufacturing Science & Technology priorities following the JSC Business Cascade (Budgeting, Resources);

• 通过技术创新和变革，调动并激发工厂团队显著提高业绩。为团队提供领导力提升和发展的机会，确保多种渠道发展高绩效复合型人才；

Motivates and inspires the site team to drive significantly increased performance through technical innovation and change.  Provides leadership and development to the team and ensures there is a diverse pipeline of high performing multi-skilled leaders of the future;

• 围绕公仆式领导者的指导原则，促进信条文化的达成，重优求异，创新，参与，合作，发展；Drives a Credo-based culture aligned around our guiding principles of servant leadership, Think Differently, Do Better, innovation, engagement, collaboration and development;
• 掌握人员管理的方方面面，包括人员招聘和解约。提供培训及发展的机会。评估绩效并反馈。如有需要，采取处分措施；

Handles all aspects of managing personnel, including hiring and terminations.  Provides coaching and development opportunities.  Evaluates performance and provides feedback. Implements disciplinary actions, as necessary;

• 密切注视并持续改进工厂制造科学与技术部的关键业绩指标。

Monitoring and continuous improvement of Site Manufacturing Science & Technology KPIs.

50%

能力范围 SCOPE DATA :     

工作范围 Size of Business:  

• 现任在职负责人支持一个工厂Incumbent will support one site:
• 根据工厂的复杂性有所不同May differ due to various complexity of the site driven by:
  • 工厂支持的业务部门（包括技术部）Business Units (as well as technologies) supported by the site
  • 工厂的使命（新产品启动和增值的工厂相对于本地化供应工厂）

Mission of the Site (Launch & Growth Site versus local access Site)

• • A类产品数量 Number of Category A Products
  • 高产量相对于低产量工厂High volume versus low volume site

总人数 Headcount:   15HC

教育和证书 EDUCATION & CERTIFICATIONS

1. 专业知识Specific knowledge

• 具备深厚的制药工艺和产品、设备方面的技术知识（如小分子、固体制剂、液剂/乳膏剂）Strong expertise on pharmaceutical manufacturing processes and products, equipment with focus on Platform Technology (Small Molecule, Solids, Liquids/Creams)
• 项目管理(FPX)，组织、计划和协调能力Project management (FPX), organizing, planning and coordination skills
• 熟知流程优化（六西格玛），精益思想和工具Process excellence (6sigma), lean concepts and tools
• 具备深厚的质量、合规、法规要求（GMP/EH&S）等知识，尤其是技术平台概念

Strong knowledge of Quality & Compliance / regulatory requirements (GMP/EH&S) especially for Technology Platform

• 具备商业头脑及财务知识（制定预算、核算成本等）Business acumen, financials (budgeting & costing)

2. 个人（领导力）技能Personal and interpersonal skills / Leadership skills

• 有能力领导跨部门合作团队Ability to lead cross functional team
• 有能力管理复杂性，应对任何变化Ability to manage complexity and change
• 能与组织内各阶层相互交流Ability to interact at different levels of the organization.
• 能承受工作压力，处理各种利益冲突，并作出决定

Ability to work under pressure, handle conflicting interests, and take decisions

• 能够在遵循大方向的前提下独当一面，对指派的任务目标优先级具有良好的判断能力，并管理好相应的时间

Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly

• 能够建立一支目的导向的（项目）团队Ability to create a result oriented (project) team
• 以客户和业务为重Costumer and business focus
• 有良好的团队合作精神Team player

3. 个人态度和心态Personal attitude and mindset

• 具有创新精神，勇于改变来确保竞争力Drives for innovation and change to ensure competitiveness
• 具有乐观进取的心态，能够灵活处理工作中的延展性目标，并达成该目标

Can-do mentality, agility & flexibility able to work with stretched goals and deadlines

• 将团队目标置于首位，与团队成员共同努力以期实现目标

Willing to place the goals of the team first and work with others towards these goals

• 善于交际、激励团队成员，具备与人磋商的能力，有自信并能影响他人

Communicative / Motivator / Negotiator / assertive person having impact

• 在专业活动中具有很高的责任心Showing a high sense of responsibility regarding professional activities

4. 良好的生产规范Good Manufacturing Practices (GMP)

• 坚持遵守cGxP的程序Adhere to applicable cGxP’s and procedures (role model)
• 报告事故和偏差Report incidents and deviations
• 提出改善符合GMP的解决方案Propose solution to improve compliance with cGMP’s

5. 安全，健康和环境绩效Safety, Health and Environment Performance

• 坚持遵守EHS&S的程序Adhere to applicable EHS&S and procedures (role model)
• 正确使用可利用的个人及集体保护设施Correct use of the available personal and collective protection materials
• 报告事故，偏差Reporting of (near) accidents, incidents, deviations
• 配合和建议方案提高EHS程序Cooperate on and suggest solutions to improve EH&S
• 当看到违反EHS规则的行为要及时制止，做出适当的行动

Act when violation of EH&S rules is observed and stimulate appropriate behavior

相关经验 RELATED EXPERIENCE:

0-2 年

9 - 12 年

3 - 5 年

13 - 15 年

6 - 8 年

15年以上

制药领域10年以上工作经验，和/或同等学力和经验：

A minimum of 10 years of experience in a pharmaceutical environment. And/Or an equivalent combination of education and experience:

1. 药物剂型工程学，制造和初级包装Dosage Forms Engineering , Manufacturing and Primary Packaging
2. 质量保证和法规Quality Assurance and Regulatory
3. 验证Validations

学位DEG REE:

药学、工程学或理科本科学历、硕士学历或同等学历。

University degree in Pharmaceutical science, Engineering or Science, Master Degree or Equivalent.

语言LANGUAGES:

当地语言流畅的书写和口语能力Fluent in written and spoken Local Language

必须条件为流畅的英语书写和口语能力Must be fluent in written and spoken English

专业系统SPECIFIC SYSTEMS:

• 文件管理系统，如ERIS和TruVault；Document management system such as ERIS, TruVault;
• 网络培训/SUMMIT系统；Web training/ SUMMIT system;
• 微软办公软件 MS Office application
• Trackwise系统 Trackwise system

身体条件/工作环境PHYSICAL REQUIREMENTS/WORKING CONDITIONS: 

在本地工厂的国际化环境下工作Works in an international environment at a local site.