苏州招聘

Responsibility:

Formulate process strategies for new biological projects entering development for IND, and scale-up and process transfer strategies for those entering late stages for BLA.


Direct and supervise the Process Development department operations in order to deliver high quality production processes and improvements.


Support production in trouble shooting of production problems. Document findings, and implement solutions.


Train direct reports and staff in scientific principles, safety issues, time management, and all other policies and regulations governing the development/production of biologics.


Prepare annual departmental budget and monitor departmental expenses and capital projects.


Participate in and/or chair appropriate product development projects, meetings and committees as assigned.



Qualifications:

Extensive experience in the development of process 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.


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 PhD degree in an applicable scientific discipline and a minimum of 5 years process development experience.


Chinese and English language skills are essential.

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。