质量控制专员
舒迪安医药研发(北京)有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2021-06-04
- 工作地点:北京
- 招聘人数:若干人
- 工作经验:5-7年经验
- 学历要求:本科
- 职位月薪:0.8-1.5万/月
- 职位类别:生物工程/生物制药
职位描述
1. 按照要求进行中间产品和终产品的检测,符合GMP操作要求。
Perform all the tests for intermediate samples and final product samples according to the test method and GMP requirement
2. 起草、升版维护SOP及操作记录,符合GDP规范
Draft and update the SOP and the records according to the GDP regulations.
3. 进行部分方法学验证工作,包括方案的起草、实施及报告的起草。
Perform the method validation, including protocol draft, execution and report preparation.
4. 负责原材料的质量标准维护及原材料的检测、报告的整理
Test the raw materials in GMP Scope, maintain the criteria of the raw materials and draft the test report. Categorize relative documents.
5. 负责指定检测方法的维护:包括物料准备和文档管理等
Prepare specific assay test as needed in daily tasks, including the materials and documents.
6. 负责流式细胞仪、qPCR等仪器设备的维护和保养,验证方法学起草和实施部分。
Responsible for FC(flow cytometry)、qPCR and other equipment for maintenance、draft of method validation and implement.
任职资格:
1. 生物、药物相关专业,本科学历,三年以上药企、生物医药行业工作经验;
Have Bachelor degree or above, major in biology or related area, above three years working experineces in pharmaceutical or bio company.
2. 有流式细胞仪操作经验,熟悉流式操作系统(eg: FlowJo v9.7.6),熟悉流式细胞仪工作原理,工作流程;
Experience in Flow cytometry operation and analysis, familiar with Flow cytometry operating system (eg: FlowJo v9.7.6), understand the work rules and process.
3. 对药企GMP有一定了解。
Experience in GMP environment.
公司介绍
舒迪安公司通过下列方式开发最新治疗方法:
采用自体细胞免疫疗法治疗癌症和自体免疫疾病
采用免疫疗法配合化疗等其他标准治疗方式提高临床疗效
研究免疫疗法的长期治疗效果以增强免疫系统对特定疾病的反应能力
使用广谱的肿瘤抗原,通过患者自身树突状细胞的活化,来刺激复杂的免疫反应
舒迪安公司的临床开发方案旨在采用活化树突状细胞免疫疗法,其自体细胞肿瘤免疫治疗产品为某些特定的、现有治疗手段匮乏的部分疾病拓展治疗选择。舒迪安在欧洲和中国北京建设了GMP标准细胞实验室,所生产的基于细胞的医疗产品均符合全球监管标准。
针对不同的癌症(前列腺癌、肺癌、卵巢癌等),舒迪安公司正在开展基于成熟树突状细胞负载免疫原性死亡肿瘤细胞技术的肿瘤免疫疗法的临床应用。多个单病种癌症的临床试验结果验证了舒迪安产品的临床安全性和有效性,显示出了令人振奋的临床治疗效果。
公司地址:北京亦庄经济开发区科创14街汇龙森科技园30号楼B座
市内办公室: 北京朝阳区亮马桥路50号燕莎写字楼C214
Company Introduction
SOTIO is a European biotechnology company developing new therapies based on activated dendritic cells, focusing on the treatment of cancer and autoimmune diseases. Our mission is to develop new medical therapies using our proprietary cell-based technologies to treat highly unmet medical conditions using our immunotherapy platform. Sotio (Beijing), a fast growing subsidiary focusing on China market, is looking for talented, motivated, dynamic employees to join its international team. The company can provide tremendous career development opportunity to its employees.
SOTIO is an Equal Employment Opportunity/Affirmative Action Employer
The policy and practice of SOTIO require that entry into employment and progression within employment will be determined only by personal merit and the application of criteria which are related to the duties of each particular job. Subject to statutory provisions, no applicant or member of staff will be treated less favorably than another because of his or her gender, marital or civil partnership status, sexual orientation, religion or belief, racial group, age or disability. In all cases, ability to perform the job will be the primary consideration.
联系方式
- 公司地址:地址:北京亦庄经济开发区科创14街汇龙森科技园30号楼B座