苏州招聘

Title: Managerof Cell Culture 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:Superviser of Cell Culture Media Development
Superviser of Cell Culture Process Development


Responsibility: Oversee cell culture process development activities.
The Director of Cell Culture Process Development is responsible for developing cell lines, optimizing expression through media development and other methods, and optimizing cell culture processes.

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 is also responsible for transfer of cell culture 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 cell culture 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 cell culture processes for monoclonal antibodies and other recombinant proteins.

The director is expected to be a technical expert in the area of process development for monoclonal antibodies. This includes expertise in cell line generation and characterization, media selection and optimization, and bioreactor process optimization. In addition, the director is expected to have expertise in testing and monitoring of cultures.

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： 细胞培养工艺开发室经理

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： 细胞培养基开发室主管，细胞培养工艺开发室主管

职责：
统筹管理细胞培养工艺开发室工作，包括人员的招聘，培训，工作安排，绩效考核等，具体还包括：
1. 负责细胞株的克隆，筛选，优化和开发工作；
2. 负责细胞培养基的选择，优化和开发；
3. 负责细胞培养工艺的开发和优化；
4. 负责细胞培养工艺由开发阶段至生产阶段的转移实施；
5. 负责细胞培养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 细胞培养工艺开发方面的丰富工作经验，
包括：细胞株的建立和特性研究，细胞培养基选择及最优化，生物反应器工艺最优化， 细胞培养的测试和监控。
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。