This position is responsible for facilitating CMC activities for projects at early and late stage in China. This individual will report to the head of CMC management department and function as CMC manager of biologics and small molecules projects. The roles include overseeing China CMC sub team and aligning with global CMC, China RACMC and CSO to track the status of the project and assessing project issues and develop resolutions to meet goals of IND/NDA filing and stakeholder satisfactions.
1.CMC Team management
From an overall optimum point of view and deep CMC-related knowledge, formulate clear CMC strategies (communicate well to global CMC Team members). Consider the development of Plan B from the perspective of risk management. At the onset of the task, take a proactive role in solving the task. Working closely with CSO to be accountable for availability of clinical supplies.
2. Regulatory Affairs
Work with RACMC to schedule regulatory affairs-related CMC tasks for clinical trial application. Collaborate with RACMC to coordinate the content and timing of consultation to authority. Actively manages CMC aspects of regulatory submissions (IND, NDA, etc.) and interactions.
3. Cross-functional communications
Ensures effective communication and collaboration of all involved functions and third parties. As a representative of the CMC related tasks in DSCN PT, participate in the project team to accurately assess the project status and to provide appropriate solutions to any issues through close communication with global CMC management and China local members. Establishes a culture of open communication and effective collaboration, drives to agreement but willing to take a stand when necessary.
•Master’s degree in Life Science, Chemistry or Pharmacy.
•Minimum of 3 years of experience in the pharmaceutical industry, better to have worked in both large molecule and small molecule areas.
•Broad understanding of all aspects of CMC is preferred.
•Have experience of process development, manufacturing, and IND and NDA filings with good working knowledge of relevant FDA, EMA and China regulations
•Strong project management skills
•Excellent interpersonal and communication skills with the ability to build strong positive relationships with all levels of the organization.
•Fluent in oral and written English