上海招聘

Job Purpose and Key Responsibilities:

With the establishment of the iTCM BU and its near term goal of in-licensing and developing clinical stage drug candidates for China market and potentially global markets, there are immediate needs of technical leaders with extensive drug R&D experience in the relevant areas of CMC and manufacturing to take responsibilities in the following:

- Lead analytical activities for the CMC development of iTCM projects
- Assist in establishing iTCM CMC development best practices and plans
- Lead the analytical due diligence efforts for CMC
- Interact with and leverage GSK internal analytical expertise and resources for development needs
- Develop quality specifications for clinical supplies
- Establish iTCM project quality control strategies
- Work effectively with other technical functional lines and matrix project teams
- Assist to develop iTCM CMC registration strategies
- Develop high quality CMC submission modules in line with CMC regulatory strategies

Accountabilities:

- Ensure analytical/QC CMC development best practices in iTCM BU for all projects
- Ensure in-licensing candidates are of suitable profile and quality in terms of QC for development and registration in China, potentially for global markets
- Ensure proper iTCM project quality control strategies at different development stage
- Ensure proper quality of relevant CMC technical and regulatory submission documents
- Ensure effective work relationship with other GSK CMC functional lines/stakeholders

Complexity:

- CMC development in iTCM is very challenging and critical for program success, particularly the development of proper quality control strategies. The analytical leader will need to resolve numerous development issues by integrating technical knowledge and project experience with business drive and skills.
- The candidate needs to be very effective communicators, interacting with other technical lines and matrix teams

Specialized Knowledge:

- Fluent in English and Mandarin (both verbal and written) required.
- Advanced pharmaceutical/science degree or equivalent.
- In-depth knowledge and experience in analytical/QC development for drug registration in China and global markets
- 10 or more years of leadership role in analytical/QC with multiple IND and/or NDA submissions, preferably including natural products

Preferred Requirements:

- R&D experience in modern TCM or natural products for Rx
- Direct experience in TCM process development
- Direct IND and/or NDA CMC section writing experience
- Experience in Reg CMC

葛兰素史克是最早在中国大规模投资研发领域的国际制药公司之一，通过与中国政府、学术机构和医疗专家保持密切的合作，致力于提高中国人民的健康水平。在进入中国的20多年间，我们在国内的药物研发和临床研究方面已投入了10亿元人民币。我们的目标是使中国成为葛兰素史克全球研发体系中一个重要的战略中心。