職位描述
主要職責1、負責為IND 授權或臨床研究階段的項目開發生物大分子活性測定方法，并完成方法驗證和轉移；2、負責為生物制品工藝開發、生產提供高質量的生物活性方法檢測支持，確保方法和操作符合相關指導原則/法規、公司標準操作規程和安全法規；3、負責起草、審核生物活性測定方法開發報告、方法確認、轉移和驗證方案及報告，操作規程等；4、負責起草并審核 IND 和 BLA 備案相關文件；5、協助質量控制團隊和其他相關部門溝通合作，以支持項目推進；6、參與相關實驗儀器的維護和培訓，完成上級領導交辦的其它工作。任職資格1、學歷及專業要求：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領域經驗；2、工作技能：具備生物制品相關的生物活性測定方法開發、驗證、轉移和檢測方法故障排除方面的專業技術知識，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 相關法規要求進行的批放行和穩定性檢測，及支持產品的特性鑒定等；熟悉 FDA/EMA/CDE的監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：具備良好的溝通協調能力，能夠批判性思考，具有良好的自驅力，工作認真注重細節，能適應快節奏的工作環境，并能夠根據不斷變化的優先級迅速調整工作4、語言技能：英文口語流利者優先；5、其他：具備監管核查相關經驗更佳。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 documentsQualifications?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
