上海招聘

主要职责/Responsibilities:

    

    

主要负责工艺技术转移，生产支持（现场支持、工艺设备性能确认、偏差调查、变更、CAPA、质量改进），工艺验证、支持新药上市申请提交。对生产过程中遇到的问题提供技术指导和建议，推动生产效能持续改进。

    

The position is responsible for technology transfers, manufacturing support (Floor support, Process Equipment PQ, deviation investigations, change controls, CAPAs, and quality improvements), process validation and NDA submission support. This position will also provide advice and guidance on manufacturing technology issues, initiatives and strategy for continuously improving manufacturing performance.

1. 作为工艺和技术的主题专家，提供现场技术支持，并且对工艺进行监控。参与偏差调查，排除可能出现的问题并解决问题。Function as a process and technology subject matter expert, provide on-the-floor and on-site technical support, and perform process monitoring, deviation investigation, troubleshoot investigation-driven events, and problem solving.
2. 审核生产主批记录和SOP、验证方案和报告、变更、偏差影响评估、风险评估、生产工艺控制策略、工艺晚期研究及工艺验证策略、工艺性能确认方案、监管申报材料等。Review Manufacturing Master Batch Records and SOPs, qualification/validation protocol and report, change controls, deviation impact assessments, risk assessments, process control strategies, PC/PV strategy, PPQ protocols and regulatory filings.
3. 生产部分BLA材料准备和申报，支持PAI及GMP现场审计。Support BLA Dossier (manufacture section), support BLA filing; support PAI (Pre-approval Inspection) and GMP audits.
4. 工艺监控和上市后的产品趋势分析。Product trend analysis for commercial products and process monitoring.
5. 主导产品工艺技术转移从临床至GMP商业化生产，商业化生产场地转移。Lead the product technology transfer including the transfer from clinical to GMP commercial plant, and from commercial plant to another commercial plant.
6. 支持新厂房设计和工艺设备选型。Support new facility design, lead the process equipment selection in new facility.

教育、资质和经验/Education, Qualifications and Experience

1. 化学或生物制药工程专业本科/硕士，5年以上生物制品开发/生物制品商业化生产相关工作经验。MSc or BSc in Chemical Engineering, Biochemical Engineering or equivalent with minimum of 5+ year’s relevant experience in biologic process or commercial biologic manufacturing.
2. 熟悉生物制品生产、cGMP，有细胞培养或工艺开发经验。Knowledge of biologic manufacturing, cGMP; Having experience in cell culture manufacturing or process development;
3. 熟悉生物制品GMP生产设备，包括但不限于生物反应器，熟悉细胞治疗生产设备优先考虑。Knowledge of biologic GMP manufacturing equipment, including bioreactor, etc. Knowledge of cell therapy manufacturing equipment is a plus;
4. 有能力撰写复杂的生产工艺流程文件，并且能够执行。在临床/GMP商业化环境提供技术支持。Demonstrated ability to perform/document complex manufacturing processes and provide technical support in a clinical/commercial GMP environment.
5. 熟悉细胞免疫学和细胞治疗生产优先。Knowledge of cellular immunology and cell therapy manufacturing is a plus.
6. 曾有过需要自觉，绩效及结果导向，和快节奏工作环境的经验。Experience working in a self-driven, performance/results oriented, fast-paced matrix environment.
7. 普通话和英语良好。Fluent in Mandarin and English.
8. 良好的沟通能力。Good communication skills.

药明巨诺是一家专注于细胞免疫治疗、处于临床阶段的创新型生物科技公司，站在巨人的肩膀上，充分结合了美国巨诺公司国际领先的技术优势以及药明康德集团强大的本土经验。

定位与愿景：
致力于以创新为先导，成为细胞免疫治疗引领者
 - 对患者：用最前沿的细胞免疫治疗技术、高品质的产品，造福中国及全球患者
 - 对行业：与国内外合作伙伴携手开展多方位合作，共建中国细胞免疫治疗的行业规范与生态系统，打造国际领先的细胞免疫治疗技术创新平台