Job Requirements
工作要求
Education/ Professional Qualification
学历/专业资格
BS or above degree in Biological Engineering, Chemical Engineering, Biochemistry, Biotechnology or related
scientific/engineering discipline.
生物工程、化学工程、生物化学、生物技术以及相关科学/工程学科本科及以上学历
Technical/Skills Required
技术/技能需求
In-depth fundamental knowledge and extensive practical experience in downstream purification and conjugation in biologics manufacturing, including conjugation, chromatography, depth filtration, viral filtration ultrafiltration, etc.; Operational experience in cell culture would be a plus
具备生物药下游纯化和偶联深入的理论知识和丰富的实操经验，包括偶联，层析、深层过滤、除病毒过滤和超滤等
Demonstrated capability in driving tech transfer and manufacturing support
具备主导技术转移和生产支持的能力
Familiar with regulations and guidelines of Health Authority (e.g., NMPA, FDA, EMA, TGA), ICH, PDA and dossier for IND or BLA
熟悉药监机构（如NMPA, FDA, EMA, TGA等）、ICH和PDA的法规和指南以及IND或BLA的注册申报
Demonstrated effective communication and cross functional collaboration in a project-oriented work environment
在以项目为导向的工作环境中能够进行有效的沟通和跨部门协作
Working Experience
工作经验
• BS with 5+ years or MS with 3+ years work experience in the Biopharmaceutical industry
学士学位不少于5年或硕士学位不少于3年的生物制药行业经验
• Experience in at least two of the following areas: process development, tech transfer, process scale-up,
process validation, manufacturing support.
具备以下至少2个领域的工作经验：工艺开发、技术转移、工艺放大、工艺验证、生产支持
• Experience in supporting regulatory submission or audit would be preferred
优先考虑有支持注册申报或审计经验的候选人
• Experience in conjugation and purification of ADC would be preferred
优先考虑有ADC偶联和纯化经验的候选人
Language, Computer Literacy, Office Software, etc.
语言能力，电脑知识，办公软件等
· Good written and oral communication skills in Chinese and English;
良好的中英文口头和书面沟通技巧；
· Familiar with software such as Microsoft Office, Microsoft project, etc.
熟悉 Microsoft Office, Microsoft project等办公软件的使用

Roles/Responsibilities
职责
• Design and execute lab studies in support of deviation investigation, change control assessment, manufacturing risk mitigation, etc. ; Participate in lab equipment purchasing, commissioning, qualification and maintenance
设计并执行实验研究来支持偏差调查，变更评估，生产风险控制等活动；参与实验室设备采购、调试、确认和维保
• Proactively collaborate with TD, CMC, MFG, quality, regulatory and other functional teams to ensure smooth tech transfer of assigned clinical or commercial products into or out of GZ manufacturing facility
主动和技术开发、CMC、生产、质量、注册以及其他部门开展合作，以确保所负责的临床或商业化产品能够顺利转入或转出广州生产基地
• Lead or participate in execution of pilot-scale experiments to determine process parameters that can be implemented at MFG scale
主导或参与执行中试实验确定可用于生产规模的工艺参数
• Provide technical support and develop timely solutions to address MFG issues
提供及时的技术支持和解决方案来处理生产上发生的问题
• Support authoring of regulatory filings and provide answers to queries from health authority as needed
支持申报资料的撰写并根据需要回答监管机构提出的问题
• Support audits and inspections as key SME
作为主要SME支持审计或核查
• Any other assignment as is determined by supervisor
完成上级安排的其他工作