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)、績效評價(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.
二.任職資格
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.