上海招聘

This API/DP manufacturing manager will be in charge of all API/DP manufacturing related aspects in new drug development process to support early stage (phase I&II) & late stage (phase III) clinical development and commercialization. He/she will be responsible for API/DP manufacturing strategy, planning and execution, and will focus on all operational aspects of the API/DP manufacturing program.

• Focus on identification, planning, and execution of key program in all CMC progress and milestones to support corporate goals.
• Ensure alignment of objectives, plans, and activities across various CMC relevant functions (e.g., R&D, Process Development, Analytical Chemistry, QC, QA, Manufacturing, Regulatory Affairs, Supply Chain, CRO and CDMO etc.)
• Be familiar with operational aspects of the program and produce documents to facilitate project tracking and progress.

Ensure that timely and consistent communications regarding CMC related program strategy, status and decisions are made within the team and to other stakeholders, including senior management.

Qualifications 

 ？  Master or PhD in a scientific discipline (e.g. pharmacology, pharmaceutical chemistry, pharmaceutics, pharmaceutical analysis, pharmaceutical administration, or a related field) is required. 

 ？  6+ years of working experience in biotech or pharmaceutical companies in drug development with expertise/knowledge in such functions as process development, pre-formulation/formulation studies, manufacturing, analytical method development and validation and quality control, etc.. Professional training/experience in project management is a plus. 

 ？  Prior experience in supporting pre-clinical and/or clinical-stage drug development programs, preferably across different phases (e.g. Phases I–III). 

 ？  Excellent collaboration, oral and written communications, influence skills and sound judgment. 

 ？  Good English skills, both written and oral.             

我们是谁？
思路迪医药,英文名称为3D Medicines(英文缩写:3D Med),是一家专注新一代肿瘤免疫治疗创新药研发及商业化的生物医药公司，秉承“帮助肿瘤患者活得更久更好”的理念，针对肿瘤治疗慢病化的未来趋势，专注为全球肿瘤患者开发差异化的新一代肿瘤免疫治疗药物，延长肿瘤患者的生存时间，改善患者生活品质。公司的产品线包括新一代生物大分子药物和小分子化学药物，并拥有一支具有国际化新药研发、注册和商业化运营能力的团队。

我们的优势？
-    围绕肿瘤慢病化的独特布局
-    多元化多支柱管线
-    极高效的研发能力及完备质量体系
-    经验丰富且全面的管理团队
-    全球范围覆盖能力

我们的价值观？
研发新一代肿瘤免疫治疗创新药的价值和目的，是为了满足肿瘤患者未被满足的需求。我们始终对改善肿瘤患者的生活充满激情，我们相信，通过创新和努力，一定能够实现帮助肿瘤患者活得更久更好的愿景。为此，我们恪守科学的态度，秉持坚定的原则，崇尚创新的精神；我们所有的努力，都是为了对抗肿瘤这一严重威胁人类健康与生命的疾病，为全球的肿瘤患者创造一个更美好的明天。