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.

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? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:  https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Accessibility and Accommodation:

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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