1、Commercial formulation and process development of small molecules to deliver the Target Product Profile through in depth understanding of the drug product development strategy, compound properties, formulation processing and drug product performance and stability, based on data of biopharmaceutical and solid state properties including polymorph, stability, solubility, excipient compatibility, and distribution coefficients；

2、Collaborate with other functional areas in discovery with key interactions with API and analytical integrators, DMPK and toxicity, QA, regulatory, clinical supply operation, external contractors and vendors and/or other relevant functions, ensures correct formulation selection；

3、Overseeing the planning and execution of the project deliverables；

4、Delivering robust clinical and commercial formulations and manufacturing processes, meeting manufacturing performance, cost needs, in line with QbD principles；

5、During technical transfer, leading the interactions with the manufacturing plant technical Launch team to ensure efficient and successful implementation of the formulation process at large scale；

6、During interaction with external CROs and CMOs, defines development and business strategies for effective management of project deliverables, and ensures CRO/CMO activities are managed within formulation department；

7、Managing the DP risk assessment and defines mitigation plans. He/she will ensure rapid identification and resolution of problems；

8、This position will be based in Shanghai, China and may require up to 15%~20% international and domestic travel.

任职要求：

1、Graduate degrees or above in Pharmaceutical Sciences or Engineering, or a related field with at least 6/8 years of working experience is required for level at Senior/Principal Scientist respectively；

2、Drug Product formulation Development experience in novel formulations with hands-on experience of developing solid dosage forms or parenteral product is necessary；

3、Demonstrated high level of technical understanding of drug product development and processing；

4、Demonstrated experience in scale up of formulation manufacturing processes and technical transfer of projects into commercial manufacturing；

5、Demonstrated leadership in providing integration of activities and delivering information across multifunctional groups and sites is required；

6、Demonstrated competency and experience in drug product formulation development within the pharmaceutical industry is expected；

7、Experience of formulation screening and optimization with modern analytical tools is expected；

8、Drug Product formulation Development experience in small molecule oral and parenteral products is preferred；

9、Drug Product formulation Development experience that spans early through late clinical phases is preferred；

10、Familiar with pharmaceutical regulations and FDA/ICH guidelines is a plus；

11、Good communication capability in both Chinese and English and positive interpersonal skills.

上班地址：张江高科牛顿路421号