Job responsibility 工作職責(zé)61 Technical responsibility技術(shù)系職責(zé)61Familiar with the establishment and optimization of large biomolecular HPLC/CE/Mass method.熟悉生物大分子HPLC/CE 方法的建立與優(yōu)化.61 Familiar with HPLC/CE method validation in release inspection and write method validation report after method validation. 熟悉放行檢查中HPLC/CE方法的驗(yàn)證，并在方法驗(yàn)證完撰寫方法驗(yàn)證報(bào)告；61 Responsible for characterization of Free thiol and CD in product quality consistency evaluation負(fù)責(zé)產(chǎn)品質(zhì)量一致性評(píng)價(jià)中自由巰基、CD等表征工作；61 Responsible for IND registration application product inspection and write pharmaceutical data.負(fù)責(zé)IND注冊(cè)申報(bào)產(chǎn)品的檢驗(yàn)及藥學(xué)資料的撰寫。Safety and environment 現(xiàn)場(chǎng)安全和環(huán)境合規(guī)61 Take part in the site safety through promotion of safe workplace and personal action. 通過宣傳安全的工作場(chǎng)所和個(gè)人行為，參與到工作現(xiàn)場(chǎng)的安全中。61 Adhere to the Company’s safety and environmental protection procedures. 遵守公司的安全環(huán)保程序。Quality Assurance 質(zhì)量要求61 Take part in Quality Management System documentation covering the development and tech transfer processes and procedures.參與整個(gè)開發(fā)和技術(shù)轉(zhuǎn)移過程和程序的質(zhì)量管理體系。61 Comply with the Company Quality Management System for development activities. 遵守公司制定的研發(fā)質(zhì)量管理體系。General 常規(guī)要求61 Take responsibility of the general operation and maintenance of the protein analytical laboratory facilities.負(fù)責(zé)蛋白質(zhì)分析實(shí)驗(yàn)室設(shè)施的一般操作和維護(hù);61 Other reasonably duties as requested by Company Senior Management from time to time.完成領(lǐng)導(dǎo)提出的其他任務(wù)Qualifications
任職資格61 Major in Pharmaceutical analysis or related field. 藥物分析相關(guān)專業(yè).61 Advanced post-graduate qualification (BS or MS) related to bioprocessing or biopharmaceutical production.相關(guān)專業(yè)的本科或碩士學(xué)歷。Essential Experience必要經(jīng)驗(yàn)61 BS degree with a minimum of 2~4 years and MS degree with a minimum of 1~3 years of large Biomolecule analysis experience.本科2~4年，碩士1~3年相關(guān)生物大分子分析經(jīng)驗(yàn)61 Expert knowledge in protein biochemistry related to protein purification and characterization of MAbs and recombinant proteins.有單克隆抗體和重組蛋白分析和表征的蛋白質(zhì)生物化學(xué)方面的專業(yè)知識(shí)。61 Familiar with the literature retrieval and relevant information inspection, and familiar with the IND filing.熟悉文獻(xiàn)檢索及相關(guān)信息檢查，熟悉IND備案；61 Advanced computer system skills for Microsoft Office suite (Word, Excel, Powerpoint, Project, Outlook); 熟練使用Microsoft Office辦公軟件 (Word、Excel、Powerpoint、Project、Outlook)Preferred Experience優(yōu)先考慮61 Project management of CMC filing for US, EU, and China IND/BLA.具有美國、歐盟和中國項(xiàng)目申報(bào)方面的管理經(jīng)驗(yàn)。61 Biophysical methods for protein characterization.熟悉蛋白表征的分析方法。61 Formal root-cause analysis training. 嚴(yán)謹(jǐn)?shù)膯栴}分析能力61 Advanced computer system skills including Unicorn, Empower, and DoE and statistical analysis.高級(jí)的計(jì)算機(jī)系統(tǒng)能力，包括Unicorn, Empower, and DoE和統(tǒng)計(jì)學(xué)分析。
職能類別：藥物分析研究員 關(guān)鍵字：hplcce生物大分子