上海招聘

Role Mission/Objective

With an increasing demand on the analytical support for both early stage and development projects, a qualified candidate is in urgent need to provide highly efficient analytical support to these projects primarily for drug products (DP). The addition of this expert will fill the gap of analytical development in DP in CMC department.

Principal Responsibilities/Duties
1.Provide full analytical support to formulation group for preclinical and clinical drug product development, including analytical & dissolution method development & validation, technical report & documentation preparation, analytical troubleshooting, release testing, and related specification setting, etc.
2.Responsible for drug product stability studies. Activities include experiment design, stability study execution, and generation of experimental summaries & reports.
3.Perform preformulation research activities if necessary. Such as comprehensive physicochemical and/or solid state property characterization of new molecular entities (NMEs) to evaluate the drug like properties and develop-ability, etc.
4.Assist analytical support to process chemistry for drug substance.
5.Serve as a resident expert in analytical development to optimize the capability of analytical development group to create innovative and efficient solutions to specific problems utilizing the state-of-the-art analytical technologies and in-depth scientific knowledge and experience.
6.Represent analytical group to attend relevant internal and external symposia/conferences for knowledge sharing and scientific presentations.
7.Lead internal analytical projects and manage related out-sourcing activities. Work collaboratively with project team and out-sourcing partners.
8.Responsible for drafting, reviewing, and implementing of analytical related SOPs or guidelines, as well as maintaining & troubleshooting of all formulation related analytical instruments.
9.Supervise 1~2 analytical scientists. Coach junior scientists in implementing innovative solutions for assigned analytical activities; be responsible for performance plan & review, and career development for direct reports.
10.May serve as CMC representative in project teams. Coordinate CMC activities related to specific projects.
11.Additional responsibilities include new technology evaluation, vendor or out-sourcing partner auditing & evaluation, and other department related activities.
12.Other related duties may be assigned to meet team and site objectives.

Qualification/Requirement
1.Ph.D. degree in analytical chemistry/pharmaceutical analysis (or closely related field).Working experience in pharmaceutical (or chemical) industry would be a plus.
2.Solid knowledge on the state-of-the-art analytical theories and technologies, and hands-on experience in operating, calibrating, maintaining and troubleshooting of a wide range of analytical instruments (HPLC, GC, IR, UV, DSC, TGA, Dissolution etc). Knowledge on preformulation theories and technologies would be a plus.
3.Demonstrated analytical development knowledge and experience for drug substance, and especially for drug product development, which includes analytical testing method development & validation, stability studies, impurity profiling, dissolution method development & validation, and related specification setting, etc.
4.Current knowledge and hands-on experience in cGMP & GLP and experience in IND/NDA dossier preparation would be a plus.
5.Must be an independent researcher; must be able to manage analytical project; must possess strong problem solving and troubleshooting abilities. Must be proactive and self-motivated.
6.Must be a good team player with good interpersonal communication skills.
7.Fluent in both written and spoken English; can deliver good presentations in English and Chinese.

罗氏研发（中国）有限公司，位于上海张江高科技园区，是中国第一家由跨国制药企业独资拥有的药物研发中心，我们将通过尝试新的药物研发途径，为国内乃至国际市场提供具有临床差异性的药物。经过5年的发展，罗氏研发（中国）有限公司从早期药物发现工作起步，建立了从早期研究到早期开发全功能的药物研发业务部门，成为一个在中国拥有大批业内专家和广泛合作伙伴的药物研发组织。我们正在寻找药物研发行业内的领军人物加入我们，让我们共同创造医疗保健领域的美好明天。