北京招聘

Responsibilities

Provide technical support for NCE formulation development and production for early phase clinical studies.

Interface with CRO partners, suppliers and clients and communicate effectively with external partners. Internally efficiently communicate with multi functions/stakeholders to make sure the formulation/DP work/their importance is understood, supported and highlighted.

Provide technical support of preclinical formulation development for PK, PD, Tox and other drug assessment studies.

Technical support of NCE developability assessment.

Design/review protocol with CRO, conduct early phase formulation development including conventional and enabling formulation, liquid and solid oral formulations.

Execute late phase formulation and process development employing DoE to achieve the quality by design.

Lead tech transfer, scale up, validation and drug product launch in clinical manufacturing site and/or commercial site in CRO/CMO or own sites.

Overseeing GMP manufacturing activities in CRO to make sure of the clinical supplies in different phase e.g. I, II, III, in quality, in quantity, on time, and within budget.

Skillset:

Ms/PhD in Pharmaceutical Sciences, Pharmaceutical or related field with at least 3-8 years of experience.

Solid knowledge in drug product formulation development and manufacturing.

Deep understanding on the pre-formulation data sets to support on formulation design.

Experience in new drug formulation development, e.g. enabling formulation e.g. ASD (amorphous spray dried), hot melt extrusion, nano sizing, emulsion, liquid capsules, etc.

Experience in conventional formulation and manufacturing process development, e.g. capsules, tablet, dry granulation, high shear wet granulation, fluid bed granulation, etc.

Experience in design and review on drug product manufacture/packaging/labeling batch records

Extra experience in pre-formulation (salt and polymorph, and solid state characterization)/API crystallization and particle size engineering, is much preferred.

Experience in modified release formulation development is the plus.

Experience in in pharmaceutical analysis/regulatory affairs is the plus.

    迪哲医药的前身为阿斯利康亚洲及新兴市场创新研发中心，设立于中国上海，是阿斯利康全球四个研发中心之一（另三个中心分别位于英国剑桥、瑞典哥德堡、美国盖瑟斯堡）；是国际一流、高产出的创新药研发机构，拥有全球领先的转化医学和新药分子设计与筛选技术平台；在恶性肿瘤、自身免疫性疾病、肾病等重大疾病的新药研究方面积累了丰富经验。
    迪哲医药，于2017年10月独立运营，是一家研发驱动型生物医药企业，致力于全球创新药物（First-in-class/ Best-in-class）探索、研发以及商业化。
    详情请点击公司官方网站：**************************/

Dizal Pharma
On Nov. 27th, 2017, through a joint venture between AstraZeneca and China Advanced Manufacturing Fund, Dizal Pharma was co-constructed as a world-leading innovative bio-pharmaceutical enterprise. As a new, unique mode of cooperation between SDIC Fund Management Company Ltd. and worldwide privileged research resources in the field of biological pharmacy, Dizal Pharma can not only accelerate the launch and listing of global new drugs in China, bring Chinese patients access to the latest drugs found across the world at once and thus raise the clinical benefits of patients; At the same time, we also take advantages of the global privileged innovative resources, increase China’s core competitive power in the innovation of new drugs, step in the leading branch of international research and development of new drugs and push China into the role of causing both huge and powerful influence in pharmacy industry.
As a new-style joint venture company, besides the project of the transfer of AstraZeneca’s patents, Dizal Pharma also develops the innovation and creation of global First-in-Class drugs.
The R&D (Research and Development) team of Dizal Pharma was AstraZeneca Asia and Emerging Market Research Center. As one of AstraZeneca’s first four R&D centers across the world, it dedicated to analyze the potential scientific mechanism of those most common diseases in Asia and fulfill the particular medical needs of Asian patients. It was one of the few R&D centers established by transnational pharmacy enterprises in China which had the ability to actually research, develop and produce micro-molecular new drugs, the ability to develop produce new drugs independently and completely, and the first-class medical platform in the world.