职位描述
职位描述: CMC项目管理主管/经理
CMC中国，方达医药技术有限公司，
方达医药技术有限公司现为公司的CMC （配方，工艺，分析，质量保证和生产）外包服务项目寻求一名项目管理经理。受聘者将直接向方达CMC中国的总经理汇报，负责协调所有CMC产品开发和生命周期管理的外包服务活动。该职位的办公地点在中国苏州，并根据工作需要，完成访问国内客户的出差任务。 该职位还负责处理与方达外包服务相关的事宜，包括准备投标回复，报价单，宣传材料等。
岗位职责：
1. 建立CMC服务策略和协调CMC项目进展
2. 参与全球项目团队的项目管理，与医疗，运营，法规等功能部门的合作
3. 督促和帮助CMC团队按时完成项目及到达里程碑
4. 协作和管理其他CRO、CMO公司及外部合作伙伴
5. 按需要，准备相关的规范性文件（模块3 ）和专利申请
6. 编制项目预算，成本和资源
7. 准备投标回复，定价总结，报价，协议等。
8. 为销售和项目管理准备宣传材料
9. 根据指示参与开发和商业生产协议的谈判
10. 作为主要客户关系经理，专注于从现有的帐户创造更多的业务
11. 保持与研发人员，业务和高级管理人员的良好工作关系及有效沟通渠道，以确保所有帐户/项目的有效管理和对客户的需求的及时响应。
12. 完成管理团队指定的其他任务
任职要求：
1. 至少3年在制药行业管理CMC外包服务项目管理的工作经验
2. 本科以上学位，优先考虑药剂，分析化学或制药工程专业
3. 能够有效地与客户的科技、项目管理、采购、运营、业务、及高级管理人员沟通
4. 有据可查的项目管理经历，有外包服务项目管理经验者优先
5. 能够判断项目的优先等级和规划切合实际的期限
6. 具备对中国CFDA和美国FDA法规熟练扎实的知识及理解
7. 流利的英语和普通话（口头和书面）
8. 精通的MS Excel，Word，PowerPoint，Outlook等软件，掌握MS Project者优先
9. 具有进取、开朗的性格、优秀的沟通及人际交往能力、流畅和专业的演讲水平
10. 具有乐观、开放的态度及面对挑战的准备
11. 愿意且能够根据需要出差，访问客户或者其他地点。
Responsibilities:
1. Establishment of the CMC service strategy and coordination of CMC project activities
2. Participate in global project teams, and collaborating with project management, Medical, Operations, Regulatory function etc.
3. Driving and facilitating the CMC teams to meet project deadlines and reach milestones
4. Collaboration with and management of CROs, CMOs and external partners
5. Preparation of relevant regulatory documentation (module 3) and patent applications, when needed
6. Preparation of project budgets on costs and resources
7. Preparation of all required bid request responses, pricing summaries, quotations, agreements, etc.
8. Prepare all promotional materials necessary to accomplish sales and project management duties
9. Participate as instructed in the negotiation of development and commercial manufacturing agreements
10. Act as the primary customer relationship manager with identified accounts focusing on generating more business from existing accounts, and /or from new accounts
11. Develop and maintain good working relationships and effective communication with R&D staff, operations and senior management to ensure all account/project activities are effectively managed and responsive to the needs of the customer
12. Other duties as assigned by management
Requirements::
1. Minimum 3 years experience in managing CMC contract services projects in pharmaceutical industry
2. BS/BA in a scientific discipline is required; ideally pharmacy, analytical chemistry or pharmaceutical engineering
3. Ability to interact effectively with clients’ scientific, project management, procurement, operations, business and senior management staff
4. Proven track record in project management; ideally contract services project management
5. Ability to prioritize and plan realistic deadline
6. Solid knowledge of the pharmaceutical industry in China and United States with a working understanding/proficiency of CFDA and FDA regulations
7. Fluent (spoken & written) in both English and Mandarin
8. Proficient in MS Excel, Word, PowerPoint, Outlook, and ideally MS Project
9. Self-starting, outgoing individual with outstanding communication and interpersonal skills, as well as a polished and professional presentation style
10. Optimistic, open minded and ready for challenges
11. Willing and able to travel as required to meet with clients at their facilities or other locations
