職位描述
職責描述:1.Responsible for preformulation support to our promising pipeline of biotherapeutics, planning and executing developability assessments負責我們有前景的生物藥的處方前研究，計劃并進行可開發性的評估2.Hands-on, laboratory-based role that supports the development of lyophilization for therapeutic protein formulations. Develop lyophilization cycles & processes to increase stability of the drug products.在實驗室領導進行新的蛋白藥物的凍干制劑處方開發，開發凍干循壞工藝等提高藥物的穩定性。3.Stability testing and characterization of routes of degradation of proteins in liquid and lyophilized formulations under accelerated temperature, refrigerated storage conditions and under agitation and freeze-thaw stresses.蛋白的水針制劑和凍干粉的穩定性測試以及降解途徑的分析，包括加速試驗、長期實驗以及振蕩、凍融挑戰實驗4.Good interpretation of biophysical instrumentation (DSC, FTIR, CD, DLS etc.) data.對于生物物理相關設備（差示掃描量熱儀，傅里葉變換紅外儀，圓二色光譜儀，動態光散射儀等）有較好地理解。5.Support of Drug Product manufacturing may be performed, which include process robustness and tech transfer activities.支持制劑成品的生產，包括生產過程的穩定性和技術轉移。6.Review analytical data for completeness and correctness.審核分析數據的完整性和正確性。7.Write formal reports for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.撰寫用于申報材料的正式的報告文件并支持和書寫合適的反饋來回答監管部門的問題。任職要求:1.PhD with 1+ years, or MS with 3+ years of industrial experience in pharmacy, pharmaceutics, biochemistry, biotechnology, or other related disciplines.制劑學、制藥學、生物化學、生物技術或其他相關背景的1年以上經驗博士或者3年以上經驗的碩士。2.Hands-on experience and deep understanding of lyophilization process development and lyophilized products有凍干制劑的實際操作開發經驗并對凍干過程和產品有深厚的理解。3.Good interpretation of protein characterization techniques, including data analysis of HPLC, CE, DLS, DSC etc.具有豐富的蛋白質表征經驗，包括高效液相色譜，毛細管電泳，動態光散射，差示掃描量熱法的數據分析。4.Strong problem-solving and troubleshooting skills.有較強的解決問題或排錯能力。5.Familiar with GMP is a plus熟悉GMP生產更佳6.Strong collaborative teamwork and excellent communication skills, is energetic, highly self-motivated and able to work efficiently and productively in a growing company environment.有較強的團隊合作精神和優秀的交流技巧，有活力，高度自我激勵并能夠在成長性企業氛圍中有效的工作。
