Hengrui Pharma
主要职责:
一、工艺开发与优化Process Development & Optimization
负责生物药下游纯化工艺开发与优化，包括深层过滤、层析分离（亲和/离子交换/疏水等）、超滤/透析、病毒灭活/去除等工艺步骤；Lead downstream purification process development and optimization for biologics, including depth filtration, chromatography (affinity/ion exchange/hydrophobic interaction), ultrafiltration/diafiltration, virus inactivation/removal, etc.
分析纯化过程中关键质量属性（CQA）与关键工艺参数（CPP），解决收率、纯度、宿主蛋白残留等技术问题；Analyze Critical Quality Attributes (CQA) and Critical Process Parameters (CPP) during purification, addressing challenges in yield, purity, host cell protein (HCP) residues, etc.
二、技术转移与项目申报Technology Transfer & Regulatory Submissions 参与中试规模纯化工艺开发（如AKTA系统操作），完成工艺放大及技术转移至GMP生产；Participate in pilot-scale purification process development (e.g., operation of AKTA systems), complete process scale-up and technology transfer to GMP manufacturing. 建立工艺开发技术文件（工艺规程、SOP、验证方案），支持IND/BLA申报资料撰写；Develop technical documentation (process protocols, SOPs, validation protocols) and support IND/BLA submission dossier preparation.
三、平台建设与管理Platform Development & Management 评估新型纯化技术（如连续流层析、膜层析）的应用可行性；Evaluate novel purification technologies (e.g., continuous flow chromatography, membrane chromatography) for potential implementation. 负责仪器的日常维护及其他下游工艺开发相关的工作。Oversee daily instrument maintenance and other downstream process development-related tasks.
任职资格： 教育背景： 硕士及以上学历，生物工程、生物化学、制药工程等相关专业。Master’s degree or above in Bioengineering, Biochemistry, Pharmaceutical Engineering, or related disciplines.
相关经验： 课题涉及蛋白纯化实验，熟悉相关仪器操作。Research projects involving protein purification experiments, with hands-on experience in operating relevant instruments.
语言要求： 具备良好的英语听说读写能力，能够流畅阅读英文专业文献，与国际同行进行技术交流。Strong English proficiency (listening, speaking, reading, writing), capable of fluently interpreting English technical literature and conducting technical communication with international peers.
预期工作地点： 上海/苏州/广州/连云港Shanghai / Suzhou / Guangzhou / Lianyungang
能力要求： 专业技能： 1、掌握层析柱装填、Western Blot等基础实验技能（有AKTA系统操作经验优先）；Proficient in fundamental experimental techniques (e.g.,
column packing ,
Western Blot );
Priority given to candidates with AKTA system operation experience . 2、了解下游纯化工艺流程（亲和层析、离子交换等）；Understanding of downstream purification workflows (e.g., affinity chromatography, ion exchange). 3、具备基础数据分析能力（Excel/UNICORN软件）；Basic data analysis capabilities (Excel/UNICORN software).
通用能力： 学习能力强，对生物制药工艺开发有浓厚兴趣；Strong learning agility and deep interest in biopharmaceutical process development. 具备系统性思维和数据分析能力，能适应高强度的研发节奏；Systematic thinking and data analysis skills, adaptable to fast-paced R&D environments. 具备独立解决问题能力及良好的跨部门协作意识。Independent problem-solving skills and cross-departmental collaboration mindset.
二、技术转移与项目申报Technology Transfer & Regulatory Submissions 参与中试规模纯化工艺开发（如AKTA系统操作），完成工艺放大及技术转移至GMP生产；Participate in pilot-scale purification process development (e.g., operation of AKTA systems), complete process scale-up and technology transfer to GMP manufacturing. 建立工艺开发技术文件（工艺规程、SOP、验证方案），支持IND/BLA申报资料撰写；Develop technical documentation (process protocols, SOPs, validation protocols) and support IND/BLA submission dossier preparation.
三、平台建设与管理Platform Development & Management 评估新型纯化技术（如连续流层析、膜层析）的应用可行性；Evaluate novel purification technologies (e.g., continuous flow chromatography, membrane chromatography) for potential implementation. 负责仪器的日常维护及其他下游工艺开发相关的工作。Oversee daily instrument maintenance and other downstream process development-related tasks.
任职资格： 教育背景： 硕士及以上学历，生物工程、生物化学、制药工程等相关专业。Master’s degree or above in Bioengineering, Biochemistry, Pharmaceutical Engineering, or related disciplines.
相关经验： 课题涉及蛋白纯化实验，熟悉相关仪器操作。Research projects involving protein purification experiments, with hands-on experience in operating relevant instruments.
语言要求： 具备良好的英语听说读写能力，能够流畅阅读英文专业文献，与国际同行进行技术交流。Strong English proficiency (listening, speaking, reading, writing), capable of fluently interpreting English technical literature and conducting technical communication with international peers.
预期工作地点： 上海/苏州/广州/连云港Shanghai / Suzhou / Guangzhou / Lianyungang
能力要求： 专业技能： 1、掌握层析柱装填、Western Blot等基础实验技能（有AKTA系统操作经验优先）；Proficient in fundamental experimental techniques (e.g.,
column packing ,
Western Blot );
Priority given to candidates with AKTA system operation experience . 2、了解下游纯化工艺流程（亲和层析、离子交换等）；Understanding of downstream purification workflows (e.g., affinity chromatography, ion exchange). 3、具备基础数据分析能力（Excel/UNICORN软件）；Basic data analysis capabilities (Excel/UNICORN software).
通用能力： 学习能力强，对生物制药工艺开发有浓厚兴趣；Strong learning agility and deep interest in biopharmaceutical process development. 具备系统性思维和数据分析能力，能适应高强度的研发节奏；Systematic thinking and data analysis skills, adaptable to fast-paced R&D environments. 具备独立解决问题能力及良好的跨部门协作意识。Independent problem-solving skills and cross-departmental collaboration mindset.