Plan and perform scientific experiments (or pilot plant processes) for the preparation and timely delivery

of drug substances (DS), drug products (DP), processes and procedures in collaboration within a multifunctional project team coordinated by a Project leader. Contribute to maintenance of lab

instruments/infrastructure.

Key Responsibilities：

•Defines the analytical strategy of development project, including analytical method development, specification setting according to ICH or Novartis guidelines

contributes to regulatory Chemistry, Manufacturing & Controls relevant dossier

effectively communicate and align the strategy with local and global project team stakeholders

•Writes, checks and/or approves analytical related documentation, including testing monograph, method validation report, transfer report, instrument qualification report and SOPs etc.

•Leads investigation of Out of Specification/Out of Expectation and Deviation, writes investigation report, defines corrective actions and preventive actions

-Follows cGMP regulations and Health Safety & Environment standards, support Novartis internal and/or Healthy Authority inspections

•Enriches the organization culture by proactively providing and implementing ideas and suggestions, coaching/mentoring of junior colleagues.

Essential Requirements:

•Master with minimal 6 years or PhD with minimal 3 years related working experience

•Fluent & effective spoken, and written communication English

-Strong inter-personal skills.

Desirable Requirements:

•Education background of analytical chemistry, pharmaceutical chemistry, medical chemistry

•Good understanding of small molecular analytical technologies, e.g. HPLC, GC, titration, IR, NMR, LC-MS

•Pharmaceutical, nutrition, or food industry working experience, familiar with FAD, EMA etc. guidelines.

为什么选择诺华：帮助患者及家属不仅需要创新科学，还需要一支包括你我他在内的充满智慧与激情的团队，大家相互协作、支持与激励。共同实现突破，改变患者的生活。一起共创更好的未来，你准备好了吗？

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薪酬与福利：您可以前往诺华官网了解我们帮助您实现个人与职业发展的举措。

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

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Benefits and Rewards: Go to Novartis career website to learn about all the ways we’ll help you thrive personally and professionally.

Materials Science

Process Simulation

Manufacturing Process

Sop (Standard Operating Procedure)

Experiments Design

Environment

Laboratory Equipment

Health And Safety (Ehs)

Technical Writing

Waterfall Model