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主要職責 1、負責為IND 授權(quán)或臨床研究階段的項目開發(fā)生物大分子活性測定方法，并完成方法驗證和轉(zhuǎn)移； 2、負責為生物制品工藝開發(fā)、生產(chǎn)提供高質(zhì)量的生物活性方法檢測支持，確保方法和操作符合相關(guān)指導原則/法規(guī)、公司標準操作規(guī)程和安全法規(guī)； 3、負責起草、審核生物活性測定方法開發(fā)報告、方法確認、轉(zhuǎn)移和驗證方案及報告，操作規(guī)程等； 4、負責起草并審核 IND 和 BLA 備案相關(guān)文件； 5、協(xié)助質(zhì)量控制團隊和其他相關(guān)部門溝通合作，以支持項目推進； 6、參與相關(guān)實驗儀器的維護和培訓，完成上級領(lǐng)導交辦的其它工作。 任職資格 1、學歷及專業(yè)要求：博士具備0-2年或碩士具備3-5年在免疫學、分析化學、生物化學、細胞生物學、分子生物學或其他相關(guān)領(lǐng)域經(jīng)驗； 2、工作技能：具備生物制品相關(guān)的生物活性測定方法開發(fā)、驗證、轉(zhuǎn)移和檢測方法故障排除方面的專業(yè)技術(shù)知識，包括基于細胞的生物測定法、ELISA方法等，以支持完成按USP、EP和 ChP 相關(guān)法規(guī)要求進行的批放行和穩(wěn)定性檢測，及支持產(chǎn)品的特性鑒定等；熟悉 FDA/EMA/CDE的監(jiān)管要求以及適用于生物制劑、藥品的 ICH 和 GMP 指導原則； 3、軟性素質(zhì)：具備良好的溝通協(xié)調(diào)能力，能夠批判性思考，具有良好的自驅(qū)力，工作認真注重細節(jié)，能適應(yīng)快節(jié)奏的工作環(huán)境，并能夠根據(jù)不斷變化的優(yōu)先級迅速調(diào)整工作 4、語言技能：英文口語流利者優(yōu)先； 5、其他：具備監(jiān)管核查相關(guān)經(jīng)驗更佳。 Main Responsibilities ?Develop, validate and transfer bioassays for IND enabling or clinical stage projects ?Provide the high-quality bioassay support for biologics production process development, manufacturing, while ensuring compliance with relevant guidelines/regulations, company SOPs, and safety regulations. ?Communicate, collaborate, and cooperate with QC functional teams and other departments to support routine project management ?Prepare, review technical documents including bioassay development reports, method protocols, qualification, transfer and validation protocols and reports, etc. ?Draft and review IND and BLA filing documents Qualifications ?Ph.D. with 0-2 years of experience, or Masters with 3-5 years of experience in Immunology, Analytical Chemistry, Biochemistry, Cell Biology, Molecular Biology, or other related fields. ?Technical expertise in bioassay method development and transfer, validation, and troubleshooting Biologics product-testing methods, including cell-based bioassay, ELISA to support product characterization, lot release and stability testing according to USP, EP, and ChP requirements. ?Previous experience with regulatory inspections is a plus ?Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals ?Excellent interpersonal, verbal, and written communication skills ?Able to think critically and demonstrate troubleshooting and problem-solving skills ?Self-starter and self-motivated; organized with good attention to detail ?Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities