苏州招聘

Title：Manager of Downstream Process Development
Reports to:VP Development
Education Level: master above plus a minimum of 5 years experience
Salary Range
Benefit Package:As defined by company policy
Direct Reports:Team Leader of Recovery Process Development
Team Leader of Purification Process Development


Responsibility: Oversee downstream process development activities.
The Director of Downstream Process Development is responsible for development and optimization of recovery and purification processes used in manufacture of Innovent products. The director is responsible for interpreting the company goals into an action plan and carrying out this plan to ensure company goals are achieved. The director of downstream process development is also responsible for transfer of recovery and downstream processes from development into manufacturing.

The director is a member of the Innovent Operations management team and as such is expected to contribute his or her expertise for the benefit of all areas of operations.

The director is responsible for the growth and development of staff within the downstream process development area. This includes compliance with company policies and diligence in ensuring a safe and professional work environment. The director is responsible for the training of development personnel in job skills, safe work practice and cGMP.

Qualifications: Extensive experience in the development of recovery and downstream purification processes for monoclonal antibodies and other recombinant proteins.

The director is expected to be a technical expert in the area of downstream process development for monoclonal antibodies. This includes expertise in recovery operations, purification process optimization, and chromatography. In addition, the vice president is expected to have expertise in analytical methods for protein testing and characterization.

The director should have experience in the development of biopharmaceutical products for registration in the US and Europe, including experience in the preparation of documents that support regulatory submissions.

The director should have a master degree in an applicable scientific discipline and a minimum of 5 years antibody process development experience. Chinese language skill is a plus.

职位名称： 下游工艺开发室经理

学历： 硕士以上，5年以上相关工作经验

汇报对象： 工艺开发部副总裁

下属： 提纯工艺开发组主任 ，回收工艺开发组主任

职责：
统筹管理下游工艺开发室工作，包括人员招聘，培训，工作安排，绩效考核等，具体还包括：
1. 负责生产过程中提纯工艺及回收工艺的开发；
2. 负责产品中病毒和杂事的却除；
3. 负责回收和下游工艺由开发阶段至生产阶段的转移实施；
4. 负责下游工艺开发室人员专业技能，工作安全，及cGMP相关培训。


要求：
1. 具有单克隆抗体和重组蛋白质下游工艺（提纯，回收）开发方面的丰富工作经验，
包括：回收工艺运作，提纯工艺最优化，色谱分析法，蛋白质测试及特性表达分析方法
2. 具有在美国和欧洲注册的生物制药产品的开发经验，包括准备相关注册文件的经验
3. 具有相关科学专业的硕士以上学位，5年以上工作经验
4. 会中文者优先

信达生物成立于2011年，致力于开发、生产和销售用于治疗肿瘤等重大疾病的创新药物。2018年10月31日，信达生物制药在香港联交所主板挂牌上市，股票代码：01801。

自成立以来，公司凭借创新成果和国际化的运营模式在众多生物制药公司中脱颖而出。建立起了一条包括32个新药品种的产品链，覆盖肿瘤、代谢疾病、自身免疫等多个疾病领域，7个产品（信迪利单抗注射液，商品名：达伯舒，英文商标：TYVYT；贝伐珠单抗生物类似药，商品名：达攸同，英文商标：BYVASDA；阿达木单抗生物类似药，商品名：苏立信，英文商标：SULINNO；利妥昔单抗生物类似药，商品名：达伯华，英文商标：HALPRYZA；pemigatinib口服抑制剂，商品名：達伯坦，英文商标：PEMAZYRE；奥雷巴替尼片，商品名：耐立克；雷莫西尤单抗，商品名：希冉择，英文商标：CYRAMZA）获得批准上市， 1个品种在NMPA审评中，另外还有19个产品已进入临床研究。

信达生物已组建了一支具有国际先进水平的高端生物药开发、产业化人才团队，包括众多海归专家，并与美国礼来制药、Adimab、Incyte、MD Anderson 癌症中心和韩国Hanmi等国际合作方达成战略合作。信达生物希望和大家一起努力，提高中国生物制药产业的发展水平，以满足百姓用药可及性和人民对生命健康美好愿望的追求。

“始于信，达于行”，开发出老百姓用得起的高质量生物药，是信达生物的理想和目标。