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或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 upstream unit operations in biologics manufacturing, including vial thaw, inoculation and seed expansion, production cell culture, centrifugation, depth filtration, etc.; Operational experience in cell culture would be a plus
具备生物药上游单元操作深入的理论知识和丰富的实操经验，包括细胞复苏、接种传代、生产培养、离心、深层过滤等
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 preferably 3+ years work experience in the Biopharmaceutical industry
学士学位外加不少于5年或硕士学位外加不少于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 and on-site auditing/inspection would be a plus
有过支持注册申报和现场审计核查的经验会是加分项
Language, Computer Literacy, Office Software, etc.
语言能力，电脑知识，办公软件等

Roles/Responsibilities
职责
• This position requires extensive experience and skills to support large-scale bioreactor production, experience with stainless steel bioreactors is preferred.
需要丰富的经验和技能来支持大规模生物反应器的生产，有不锈钢反应器经验优先
• Proactively collaborate with PD, 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
主动和工艺开发、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
• 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
• Participate in execution of pilot-scale experiments to determine process parameters that can be implemented at MFG scale
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