广州招聘

职位描述：
负责管理细胞疗法产品的加工及国内主要的起始物料的生产。主要负责临床试验的物料生产，未来商业性生产以及支持研究和发展规划。
Full time role managing processing of cell therapy products and manufacturing their key starting materials based in China. This function is responsible for production of materials for clinical trials, future commercial production, and some support of research and development programs.

1. 工作计划：设置每年生产预算以确保有足够的资源
Work planning: Setting annual production forecast and ensuring adequate resources are in place to meet forecast.
2. 运用重组基因技术、细胞培养和生物技术纯化工艺制造细胞疗法产品和主要起始原料
Manufacturing cell therapy products and key starting materials using recombinant gene technology, cell culture, and biotechnology purification processes.
3. 管理和汇报生产运营
Managing and reporting production operations.
4. 建立并管理生产团队
Building and managing a strong production team.

主要职责ESSENTIAL FUNCTIONS
主要职责包括但不限于：Essential functions include, but are not limited to the following
工厂安全Site Safety
主动积极并在遵循公司政策流程的基础上确保工厂的安全运行
Contributing to the safe operation of ICT facilities through personal initiative and adherence with Company procedures.
实现零损失工时事故
Zero lost-time injuries for Production team

生产Production
符合CFDA/US-FDA和欧洲GMP的基础上管理细胞治疗产品和关键起始物资的生产
Manage pro duction of cell therapy products and key starting materials in accordance with CFDA, US-FDA and EU GMP.
管理生产日程以确保按预期提供患者治疗的产品
Manage the production schedule to ensure timely delivery of on patient treatments in line with forecast.
负责人员权限审批，管理设备、分类洁净室和其他生产区域的清洁管理
Responsible for production assets including approving personnel access, managing cleaning of equipment and classified cleanrooms, and cleaning of other production areas.
适时评估批量生产记录和其他质量系统文件
Timely review of Batch Manufacturing Records and other quality system documentation.
支持工作时间外包括双休的工作安排以根据生产需求满足患者治疗
Support out-of-hours work including weekends to meet demanding production schedule for delivery of patient treatments when required.

质量Quality
准备和批准在整个生产工艺中的SOP和相关记录: 材料规格、工作指导、批生产记录、材料清单以及设备使用日志
Prepare and approve standard operating procedures and associated records covering the full production process: material specifications, work instructions, batch records, bill of materials, and equipment usage logs.
及时有效地提高并关闭变更、偏差及纠正和预防措施等的质量事件
Raise and close Quality Events including Change Controls, Deviations, and CAPA in a timely manner.
与质控、维护及验证部门合作以确保生产设备在验证状态
Maintain the validated state of production equipment in collaboration with other manufacturing departments: Qualification, maintenance, and calibration.
评估并审核生产员工提交的管控文件
Review and approve controlled documents prepared or executed by other production staff.
遵守并持续改进公司的质量管理体系
Comply with, and continuously improve, the Company Quality Management System.
代表生产部参与质量审计和管理检查
Represent Production activities at Quality Audits.

设计Design
选择生产设备并评估审批设计规范
Select production equipment and review and approve design specifications.
开展验证风险评估工作座谈会议，记录失效模式和机制以掌握关键质量情况
Contribute to risk assessment workshops to document failure modes and mechanisms for control of critical-to-quality attributes.

管理Management
管理生产部门的员工实现部门目标，提交周报月报
Manage team Production staff to achieve overall department objectives, providing weekly and monthly reports.
招聘并培训生产员工
Recruit and train production staff.
为生产部成员设定个人目标和绩效考核以实现部门目标
Set and performance-manage progress against individual objectives for Production staff.
设定人员、物料和设施需求的运营预算，管理营运开支以不超过预算的10%
Set manpower, material, and facility requirements for operating budget and manage operating expenditure to within 10% of budget.
积极鼓舞团队士气
Contribute positively to team morale.
任职资格：
1.科学、生物技术或制药专业优先
2.8年以上GMP制造行业的经验，包括管理团队、设施和运营预算。
理解GMP，特别是无菌或生物技术的药用产品
Sound understanding of Good Manufacturing Practice (GMP) with particular attention to aseptic or biologic medicinal products.
有CFDA/欧洲/美国GMP的工作经验
Experience of EU and/or US-FDA GMP compliance as well as CFDA.
细菌发酵或细胞培养的实际操作经验
Hands-on experience in bacterial fermentation and/or cell culture.
有管理A或B级无菌技术的分类洁净室运行的经验
Previous responsibility for operation of classified cleanrooms to Grade A/B using Aseptic technique.
有设施设计、启动或新产品引进的经验
Experience in facility design/start-up and or new production introduction.
可使用自动化和机械系统
Comfortable working with automated and mechanical systems.
管理30人左右的团队包括招聘、绩效考核、激励团队
Management of teams up to 30 staff: Recruiting, performance management, and motivation to build a high-performance team.
有轮班和一周工作7天的经验
Previous experience with shift-work and operation 7 days per week.
熟练使用办公软件使用
Advanced document writing skills using MS Office suite.
熟悉如DMS/eQMS/LIMS/MES/ERP或EMS的电子信息系统的操作
Familiar with operation of electronic information systems such as DMS, eQMS, LIMS, MES, ERP, and/or EMS.
熟练使用中文与内外部人员沟通，精通英语口语理解，并能理解英语技术文件
Strong communication skills in Chinese to engage with personnel across the Company and service providers, strong understanding of spoken English, and sound reading comprehension of technical documentation in English.
须通过处理人血制药的药师考试
Must pass physician examination allowing handling of human blood-based medicines. 举报 分享

上海斯丹赛生物技术有限公司定位于成为全球细胞治疗及再生医学领域的领航者，致力于服务科技创新和人类健康，在细胞治疗和基因编辑等领域，共递交专利申请多项并多次发表国际水平文章，在CAR-T细胞治疗领域中已走在行业前列。针对难治复发性白血病完全缓解率达85%，达到国际领先水平。在治疗淋巴瘤患者中取得了显著的临床效果，同时实体瘤的研发也已进入临床阶段。斯丹赛现已开始布局全球化战略，同时向中美两国递交了注册申请，已获批中国药监局临床试验，并已开展药物临床试验。公司计划两年内完成纳斯达克上市。