崗位職責(zé):
1. 設(shè)計并開展大分子蛋白藥物的理化性質(zhì)研究,如抗體、雙抗、融合蛋白、ADC等。
Design and conduct physicochemical property studies for large molecule protein drugs, such as antibodies, bispecific antibodies, fusion proteins, ADCs, etc.;
2. 進行蛋白藥物分析方法開發(fā)、方法確認和驗證,包括但不限于SEC, CE-SDS、電荷變異體、糖型、表達量、以及產(chǎn)品及工藝相關(guān)雜質(zhì)檢測等,產(chǎn)生高質(zhì)量數(shù)據(jù),并對數(shù)據(jù)進行分析,撰寫報告。
Develop analytical methods, including but not limited to SEC, CE-SDS, charge variants, glycan, titer, , and product/process-related impurity analysis. Perform analytical method qualification and validation. Generate high-quality data, make conclusion and reports.
3. 支持細胞系開發(fā)、上下游工藝、制劑處方開發(fā)高通量樣品分析,對數(shù)據(jù)結(jié)果進行分析和反饋;支持工藝放大和中試階段檢測工作,進行早期臨床穩(wěn)定性研究。
Support high-throughput sample analysis for cell line development, upstream/ downstream processes, and formulation development. Analyze and provide feedback on data results. Support analytical testing during process scale-up and pilot phases. Conduct early clinical stability studies.
4. 按要求完成實驗記錄、研究方案和報告等資料撰寫,保證數(shù)據(jù)完整性。
Complete experimental records, study protocols, and reports in accordance with requirements, ensuring data integrity.
5. 負責(zé)相關(guān)儀器、設(shè)備的維護和保養(yǎng)。
Responsible for the maintenance and upkeep of relevant instruments and equipment.
任職要求:
1. 生物化學(xué)、分析化學(xué)、藥物化學(xué)或相關(guān)學(xué)科的本科或碩士,2年及以上制藥或生物技術(shù)公司工作經(jīng)驗。
Bachelor or Master’s degree in biochemistry, , analytical chemistry,pharmaceutical chemistry, or related background with 2+ years of biotech industrial experience.
2. 熟練掌握大分子分析技術(shù),精通高效液相色譜及毛細管電泳技術(shù),包括但不限于HPLC, UPLC, CE-SDS, iCIEF等。
Hands-on experiences in analytical development and/or quality control testing for biologics, with expertise in high-performance liquid chromatography and capillary electrophoresis techniques including but not limited to HPLC, UPLC, CE-SDS, iCIEF, etc.
3. 文獻閱讀和解決問題的能力,良好的溝通和團隊合作能力,較強的責(zé)任心和執(zhí)行能力。
Literature search to solve problem as needed ; good communication and teamwork skills;strong sense of responsibility; excellent execution ability.