崗位職責(zé):
1.根據(jù)工藝開發(fā)進(jìn)度,組織實(shí)施中間樣品、non-GMP相關(guān)方法開發(fā)和檢驗(yàn)工作,如結(jié)合活性、生物活性HCP、HCD、protein A殘留等。
According to the progress of process development, organize and implement the relevant method development and inspection assay for in process and non-GMP samples, such as Binding assay、Bioactivity、HCP、HCD、protein A residue,etc.
2.負(fù)責(zé)起草檢測(cè)方法和儀器操作的SOPs,包括分析方法、儀器操作,并進(jìn)行方法轉(zhuǎn)移至QC部門。
Responsible for drafting SOPs related to method and instrument operation and transfer the methods to the QC department.
3.負(fù)責(zé)生化相關(guān)分析方法開發(fā)報(bào)告的起草和審核工作,以及質(zhì)量板塊CTD注冊(cè)資料的撰寫。
Responsible for drafting and reviewing method development reports related to biochemical assay and the write the CTD registration materials for the quality section.
4.負(fù)責(zé)管理、維護(hù)保養(yǎng)檢驗(yàn)設(shè)備,確保檢驗(yàn)設(shè)備可正常運(yùn)行且在有效期內(nèi)。
Be responsible for the management, maintenance and inspection of testing equipment to ensure that the testing equipment can operate normally and is within the validity period.
5.負(fù)責(zé)AD生化團(tuán)隊(duì)的日常管理、年度培訓(xùn)、績(jī)效評(píng)價(jià)、成本優(yōu)化等。
Responsible for daily management, annual training, performance evaluation, cost optimization, etc. of the AD biochemical team.
6.完成領(lǐng)導(dǎo)分配的其他工作和職責(zé)。
Any other job and responsibilities assigned by manager.
任職要求:
1、至少具有藥學(xué)或生物相關(guān)專業(yè)碩士學(xué)歷(或中級(jí)專業(yè)技術(shù)職稱或執(zhí)業(yè)藥師資格)。
Must, at a minimum, have an educational qualification of an master course in pharmacy or biological related sciences (or with a technical title at middle grade or licensed pharmacist)
2、至少3年從事抗體類生物制品生化相關(guān)分析的實(shí)踐經(jīng)驗(yàn)。
At least 3 years hand on experience in biochemical analysis of antibody biologics.
3、能夠閱讀相關(guān)的英文資料。
Be able to read related English materials.