北京招聘

职位描述：
Director- CMC Management
Primary Location: Shanghai
Schedule: Full-time
Shift: Day
Job Level: Director
Travel: Shanghai-Shaoxing

Responsibilities:
？Serve as the CMC project leader for assigned products.
？Lead cross-functional CMC Teams for assigned projects and ensure team focus and accountability to achieve goals and deliverables. 
？Lead the development of CMC plan and ensure it align with the overall project plan.
？Maintain effective comminucation with internal and external responsible parties.
？Define all CMC activities required for implementation of the product clinical/commercial plan, ensure alignment with company’s overall business strategy.
？Develop the Product Definition and CMC Strategy documents with appropriate input from cross-functional team members
？Anticipate and identify project risks and develop resolution plans.
？Monitor and control the CMC process; within budget, and timeline.
？Prepare monthly and annual status report.


Qualifications:
？Bachelor degree or PHD preferred.
？7+ years of technical experience in one or more areas of CMC development and in charged of at least one CMC project.
？Strong knowlege of Chinese CMC regulations and guidelines applicable to oncology drugs including NDA and IND filing requirements.
？Experience with early-stage CMC development and clinical manufacturing of biologics is strongly preferred.
？Strong working knowledege of GMP.
？Experience leading global and/or virtual team is preferred.
？Experice with CMC technical content for regulatory submission is preferred.
？Strong knowledge on all phases of drug development.
？Excellent communication skill on both oral and written, both in Chinese and English.
？Execellent organizational skill.
？Excellent problem-solving skills
？Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving. 举报 分享

德琪医药有限公司（简称“德琪医药”，香港联交所股票代码：6996. HK）是一家专注于创新抗肿瘤药物的亚太地区临床阶段生物制药公司，德琪医药旨在为亚太地区及全球各地的患者提供全新作用机制的抗肿瘤创新疗法。自成立以来，德琪医药已建立起拥有12款临床及临床前创新药物的丰富产品管线，取得9个临床批件，并在亚太地区开展9项跨区域临床试验。公司在研产品专注于创新的靶点或作用机制，并拥有成为同类首款潜力的药物。德琪人以“医者无疆，创新永续”为愿景，力争通过对全球***和同类最优的专研与市场化，解决亚太乃至全球患者未满足的临床需求。