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 herb sourcing/cultivation/supply activities for the CMC development of iTCM projects
- Responsible for establishing iTCM herb source development best practices and plans
- Lead the herb sourcing/supply chain due diligence efforts for CMC
- Interact with and leverage GSK internal CMC expertise and resources for development needs
- Define and meet clinical manufacture needs, outline commercial plans for herb supplies
- Establish preferred vendors/collaborators for GAP or GMP compliance
- Able to assist extraction process development
- Work effectively with other technical functional lines and matrix project teams

Accountabilities:

- Manage herb raw material supplies for CMC development in iTCM BU for all projects
- Ensure in-licensing candidates have suitable herb raw material supplies in terms of cultivation development and registration in China, potentially for global markets
- Ensure proper conduct of herb supply CMC due diligence
- Ensure proper quality of relevant CMC technical and regulatory submission documents
- Ensure effective work relationship with other GSK and RDC CMC functional lines/stakeholders

Complexity:

- CMC development in iTCM is very challenging and critical for program success, including herb raw material supplies. The incumbent 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 in matrix teams and local herb cultivators.

Specialized Knowledge:

- Fluent in English and Mandarin (both verbal and written) required.
- Advanced pharmaceutical/science/TCM cultivation degree or equivalent.
- Broad knowledge in TCM cultivation and supply in terms of technology and regulatory requirements
- In-depth knowledge about herb GAP development
- 8 or more years of leadership role in herb supply management for TCM products
- Able to travel extensively to survey or develop cultivation farms
- R&D experience in modern TCM or natural products for Rx
- Hands-on TCM extraction process development experience

Preferred Requirements:

- 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。