摘要
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.
About the Role
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
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
