QC部门副经理
杭州多禧生物科技有限公司
- 公司规模:50-150人
- 公司性质:合资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2021-01-12
- 工作地点:杭州-江干区
- 招聘人数:1人
- 工作经验:3-4年经验
- 学历要求:本科
- 语言要求:英语良好
- 职位月薪:14-24万/年
- 职位类别:生物工程/生物制药 医药技术研发管理人员
职位描述
1、依据国内外法规,管理与指导质量控制部的工作,协助QC经理的工作;
2、负责质量控制室GXP文件系统,包括管理过程、操作规程等;
3、依照相关SOP及QS文件,审查部门中控测试,包括起始物料、原辅料、包装材料、中间产品、成品、公用系统检测等;
4、负责质量控制室确认与验证方案的起草与审核,包括仪器确认,分析方法验证以及其他需要进行的验证与确认;
5、参与检验过程中出现的偏差、OOS、OOT调查;
6、负责与其他部门的沟通,协调检验事宜;
7、参与分析方法开发与验证;
8、负责安排原辅料及制药用水的取样;
9、负责原辅料及成品等的稳定性考察与留样观察;
10、负责对检验用的设备、仪器、标准品、菌种、试剂等制定管理办法;
11、保证实验室按照GMP正常运行;
12、负责上级领导指派的其它相关工作。
职位要求:
1、生物相关专业本科或硕士学历。
2、药企质量控制3年及以上工作经验,有团队管理经验。
3、熟悉ChP,USP,EMP,ICH等国际法规和指导原则。
4、有生物药IND申报或商品生产经验的优先。
公司介绍
正在迅速成长的杭州多禧生物科技有限公司位于中国的“天堂”城市杭州。公司由五位在美国生物制药界分别有二十多年经验的海归科学家创立,致力于研发新一代被誉为“生物***”的抗体-药物共轭体(ADC)抗癌药物,志在挽救成千上万癌症患者的生命。我们团队成员曾作为技术骨干为当今治疗乳腺癌最有效的ADC药物Kadcyla的成功上市做出重要贡献。拥有数项自主知识产权的多禧生物正在迅速成为本领域的全球领跑者之一,现在加盟本公司恰逢其时。如果您是有活力的、梦想成功的专业人士,杭州多禧生物科技有限公司将为您提供一片发现、应用和发展才能的沃土。
Hangzhou DAC Biotech Co.,Ltd. is a rapidly growing start-up located in the “paradise” city of China. As a biotech company established by five oversea returnee scientists who each had more than 20 years of experience in the US pharmaceutical industry respectively, we focus on developing next generation antibody-drug conjugates (ADC) or so-called “biological missiles” for cancer treatment. The goal is to develop a technology to save hundreds and thousands of cancer patients’ lives. As key scientists in a pioneering ADC company previously, our team members had made crucial contributions to the success of Kadcyla, an ADC that is currently the most efficacious drug for the treatment of breast cancer. With several proprietary technologies and related patents in hand, our company is quickly becoming one of the global leaders in the development of ADC platform technology. It is an exciting time to work at Hangzhou DAC Biotech. If you are a dynamic, success-driven professional, our company is the place where you can identify, utilize and develop your talents.
公司优势
1. 员工享有股权激励和其他福利、保险、带薪休假、年度体检、和午餐补贴等;
2. 公司关心员工的前程,并将大力培育员工的成长;
3. 公司尊重员工,并将为员工提供各方面的权益保护;
4. 对于员工所作出的突出贡献,公司也将格外突出地奖励;
5. 公司会为员工准备不定期的惊喜。
简历投放:email: info@dacbiotech.com
或:浙江杭州市杭州经济技术开发区6号大街260号12幢,邮编310018
Hangzhou DAC Biotech Co.,Ltd. is a rapidly growing start-up located in the “paradise” city of China. As a biotech company established by five oversea returnee scientists who each had more than 20 years of experience in the US pharmaceutical industry respectively, we focus on developing next generation antibody-drug conjugates (ADC) or so-called “biological missiles” for cancer treatment. The goal is to develop a technology to save hundreds and thousands of cancer patients’ lives. As key scientists in a pioneering ADC company previously, our team members had made crucial contributions to the success of Kadcyla, an ADC that is currently the most efficacious drug for the treatment of breast cancer. With several proprietary technologies and related patents in hand, our company is quickly becoming one of the global leaders in the development of ADC platform technology. It is an exciting time to work at Hangzhou DAC Biotech. If you are a dynamic, success-driven professional, our company is the place where you can identify, utilize and develop your talents.
公司优势
1. 员工享有股权激励和其他福利、保险、带薪休假、年度体检、和午餐补贴等;
2. 公司关心员工的前程,并将大力培育员工的成长;
3. 公司尊重员工,并将为员工提供各方面的权益保护;
4. 对于员工所作出的突出贡献,公司也将格外突出地奖励;
5. 公司会为员工准备不定期的惊喜。
简历投放:email: info@dacbiotech.com
或:浙江杭州市杭州经济技术开发区6号大街260号12幢,邮编310018
联系方式
- Email:info@dacbiotech.com
- 公司地址:杭州经济技术开发区6号大街260号中自科技园12幢 (邮编:310018)
- 电话:17816137507