崗位職責:
1.? 負責制劑工藝開發部門、團隊建設及管理工作。
Be responsible for the construction and management of the formulation process development department.
2.? 負責項目制劑開發策略及計劃,及產品使用方式、作用機理、技術指標、技術可行性分析及專利可行性分析。
Be responsible for the formulation development strategy and plan of the project, as well as the analysis of the usage mode, mechanism of action, technical indicators, technical feasibility and patent feasibility of the product.
3.? 負責制定制劑工藝開發階段性目標,拆解工作任務并合理安排組員進行工作。
Responsible for formulating stage goals of purification process development, dismantling work tasks and reasonably arranging team members for work.
4.? 完成工作總結及匯報,參與并監督工藝開發過程中各方案制定、撰寫及執行,完成后報告撰寫,對輸出結果負責。
Complete the work summary and report, participate in and supervise the formulation, writing and implementation of each plan in the process of process development, write the report after completion, and be responsible for the output results.
5.? 能獨立負責制劑工藝開發放大,并能協調相關部門完成相關工作。
Independently responsible for the development and amplification of preparation process, and able to coordinate relevant departments to complete related work.
6.? 負責與客戶對接、交流、匯報工作,保證任務的即時、準確、專業性。
Responsible for communicating, communicating and reporting with customers to ensure the promptness, accuracy and professionalism of tasks.
7.? 完成制劑相關項目管理和申報,確保符合注冊法規與行業趨勢。
Complete preparation related project management and application to ensure compliance with registration regulations and industry trends.
8.? 負責制劑研發成本的核算。
Responsible for the cost accounting of preparation R&D.
9.? 負責管理、維護保養檢驗設備,確保檢驗設備可正常運行且在有效期內。負責新設備的安裝、調試、校準、確認以及設備檔案的建立工作。
Responsible for the management and maintenance of the inspection equipment to ensure that the inspection equipment can operate normally and within the validity period. Responsible for new equipment installation, debugging, calibration, validation and equipment file establishment.
10.? 完成領導分配的其他工作和職責。
Complete other tasks and responsibilities assigned by the leader.
任職要求:
1、微生物學,化學工程,生化工程等理學或生物制藥,制藥工程等工學學士及以上,碩士優先。
2、至少五年以上從事制劑相關工作(醫藥固液無菌制劑類工作經驗優先)的實踐經驗。
3、能夠閱讀相關的英文資料。