崗位職責(zé):
1.負(fù)責(zé)指定項目開發(fā)策略及計劃。
Responsible for specifying project development strategies and plans.
2.負(fù)責(zé)制定生物偶聯(lián)工藝開發(fā)階段性目標(biāo),拆解工作任務(wù)并合理安排組員進行工作。
Responsible for formulating stage goals of coupling process development, dismantling work tasks and reasonably arranging team members for work.
3.完成工作總結(jié)及匯報,完成制藥工藝開發(fā)過程中各方案制定、撰寫及執(zhí)行,完成后報告撰寫。
Complete the work summary and report, complete the formulation, writing and implementation of various plans in the process development process, and write the report after the completion.
4.能獨立負(fù)責(zé)偶聯(lián)工藝開發(fā),并協(xié)助放大生產(chǎn)。
Independently responsible for the development of coupling process and assist in the scale-up of production.
5.完成偶聯(lián)相關(guān)項目管理和申報,確保符合注冊法規(guī)與行業(yè)趨勢。
Complete the management and application of coupling related projects to ensure compliance with registration regulations and industry trends.
6.負(fù)責(zé)偶聯(lián)研發(fā)成本的核算。
Responsible for the cost accounting of coupling research and development.
7.負(fù)責(zé)管理、維護保養(yǎng)檢驗設(shè)備,確保檢驗設(shè)備可正常運行且在有效期內(nèi)。負(fù)責(zé)新設(shè)備的安裝、調(diào)試、校準(zhǔn)、確認(rèn)以及設(shè)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.
8.完成領(lǐng)導(dǎo)分配的其他工作和職責(zé)。
Complete other tasks and responsibilities assigned by the leader.
9.負(fù)責(zé)保證所有的活動符合GMP/GLP的要求。
Be responsible for assuring that all the activities are in line with GMP/GLP requirement.
10. 負(fù)責(zé)保證所有的檢測活動符合公司和總部的EHS方針和要求,確保檢測的環(huán)境是安全的,人員的保護設(shè)備能按要求正確地使用。
Be responsible for assuring that all the testing activities are in line with the company and corporate EHS policies and requirements. Make sure that the production environment is safe and personal preventive equipment properly used as required.
任職要求:
1. 至少五年以上從事生物制藥偶聯(lián)相關(guān)工作(至少包括ADC)的實踐經(jīng)驗。
At least 5 years of practical experience in coupling related work (including ADC at least).
2. 能夠閱讀相關(guān)的英文資料。
Be able to read related English materials.