莆田招聘

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 senior leaders with extensive drug R&D experience in the relevant areas of CMC and manufacturing to take responsibilities in the following:

Lead all CMC activities for iTCM projects
Establish iTCM CMC development best practices and plans
Identify and review potential natural product in-licensing candidates
Lead CMC due diligence efforts
Interact with and leverage GSK internal CMC expertise and resources for development needs
Define and meet clinical manufacture needs, outline commercial manufacture plans
Define supply chain control and management plans
Establish preferred vendors/collaborators for GAP and GMP compliance
Work effectively with other technical functional lines and matrix project teams
Accountabilities:

Ensure CMC development best practices in iTCM BU for all projects

Ensure in-licensing candidates are of suitable profile and quality for development and registration in China, potentially for global markets

Ensure proper conduct of CMC due diligence

Ensure proper quality of CMC technical and regulatory submission documents

Ensure effective work relationship with other GSK and RDC CMC functional lines/stakeholders

Complexity:
degree of change & uncertainty; level of influencing required; degree of matrix working

- CMC development in iTCM is the most challenging and critical for program success. The CMC leaders 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 key stakeholders, regulators and other technical lines and matrix teams
Specialized Knowledge:
breadth & depth across disciplines or functions; expertise in field required; separate by basic and preferred

1. Fluent in English and Mandarin (both verbal and written) required.
2. Advanced pharmaceutical/science degree or equivalent.
3. In-depth knowledge and experience in CMC development for drug registration in China and global markets
4. 10 or more years of leadership role in CMC with multiple IND and/or NDA submissions, preferably including natural products

Basic Requirements:
Must be non-comparative, objective and relevant. Critical/essential to accomplish the role

Preferred Requirements:
Relevant to the role, but not critical/essential
1. R&D experience in modern TCM or natural products for Rx
2. Direct IND and/or NDA CMC section writing experience
3. Supervisory experience (people, technical and vendor)
4. Supply chain management experience

GlaxoSmithkline/葛兰素史克
作为世界领先的制药业巨擘，葛兰素史克公司秉承以研究开发为基础的一贯理念，凭藉公司本身的技术潜力和资源优势，在当今瞬息万变的医疗保健领域保持强劲的增长势头。
葛兰素史克公司，由葛兰素威康和史克必成强强联合，于2000年12月成立。两家公司的历史均可追溯至19世纪中叶，各自在一个多世纪的不断创新和数次合并中，在医药领域都确立了世界级的领先地位。两个制药巨人的成功合并，为葛兰素史克成为行业中无可争议的领导者奠定了基础，并在全球药品市场中占据有7%的份额。
葛兰素史克公司总部设在英国，以美国为业务营运中心，在抗感染、中枢神经系统、呼吸和胃肠道/代谢四大医疗领域代表当今世界的最高水平，在疫苗领域雄居行业榜首。此外，公司在消费保健领域也居世界领先地位，主要产品包括非处方药、口腔护理品和营养保健饮料。2006年公司在全球的销售总额达232亿英镑。目前，公司在全球拥有10万余名既掌握专业技能又有奉献精神的出色员工。
全球研发中心有1万6千科学家和技术人员分布在全球许多国家。为进一步推动研发全球化，葛兰素史克(GSK)中国研发中心于2007年6月成立。中心将侧重于神经退行性病变的研究，目标是为多发性硬化病、帕金森病和阿尔茨海默氏病等严重疾病开发新药。中国研发中心将发展成有1000多科学家和技术人员的全球研发中心。中心将以科学研究为基础（science-driven），通过生物学，化学以及最新技术，创新开发新的治疗手段。中国研发中心将最终引领GSK在这一领域从识别药物靶标到后期临床研究的全球研发活动，并在中国和其他研究机构密切合作。GSK中国研发中心计划在未来10年内成长为GSK的大型研发中心之一。
更多信息请访问我们的网站：www.gsk.com or www.gskchina.com