職位描述
職位描述: CMC項目管理主管/經理
CMC中國，方達醫藥技術有限公司，
方達醫藥技術有限公司現為公司的CMC （配方，工藝，分析，質量保證和生產）外包服務項目尋求一名項目管理經理。受聘者將直接向方達CMC中國的總經理匯報，負責協調所有CMC產品開發和生命周期管理的外包服務活動。該職位的辦公地點在中國蘇州，并根據工作需要，完成訪問國內客戶的出差任務。 該職位還負責處理與方達外包服務相關的事宜，包括準備投標回復，報價單，宣傳材料等。
崗位職責：
1. 建立CMC服務策略和協調CMC項目進展
2. 參與全球項目團隊的項目管理，與醫療，運營，法規等功能部門的合作
3. 督促和幫助CMC團隊按時完成項目及到達里程碑
4. 協作和管理其他CRO、CMO公司及外部合作伙伴
5. 按需要，準備相關的規范性文件（模塊3 ）和專利申請
6. 編制項目預算，成本和資源
7. 準備投標回復，定價總結，報價，協議等。
8. 為銷售和項目管理準備宣傳材料
9. 根據指示參與開發和商業生產協議的談判
10. 作為主要客戶關系經理，專注于從現有的帳戶創造更多的業務
11. 保持與研發人員，業務和高級管理人員的良好工作關系及有效溝通渠道，以確保所有帳戶/項目的有效管理和對客戶的需求的及時響應。
12. 完成管理團隊指定的其他任務
任職要求：
1. 至少3年在制藥行業管理CMC外包服務項目管理的工作經驗
2. 本科以上學位，優先考慮藥劑，分析化學或制藥工程專業
3. 能夠有效地與客戶的科技、項目管理、采購、運營、業務、及高級管理人員溝通
4. 有據可查的項目管理經歷，有外包服務項目管理經驗者優先
5. 能夠判斷項目的優先等級和規劃切合實際的期限
6. 具備對中國CFDA和美國FDA法規熟練扎實的知識及理解
7. 流利的英語和普通話（口頭和書面）
8. 精通的MS Excel，Word，PowerPoint，Outlook等軟件，掌握MS Project者優先
9. 具有進取、開朗的性格、優秀的溝通及人際交往能力、流暢和專業的演講水平
10. 具有樂觀、開放的態度及面對挑戰的準備
11. 愿意且能夠根據需要出差，訪問客戶或者其他地點。
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
