Expert Science & Technology II- Analytical Research & Development

Summary

Novartis Technical & Research Development (TRD) Changshu (Jiangsu province, China) site is responsible for around 80% of global Novartis New Chemical Entity (NCE) project portfolio. This role is critical for pre-clinic and clinic drug substance quality control strategy defining and execution by applying state of the art analytical technology, pharmaceutical industry regulations, as well as Novartis group systematic quality and compliance policies.

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

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.

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.

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

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

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

Division
Development

Business Unit
Innovative Medicines

Location
China

Site
Changshu (Jiangsu Province)

Company / Legal Entity
CN23 (FCRS = CN023) Suzhou Novartis Technical Development Co., Ltd.

Functional Area
Research & Development

Job Type
Full time

Employment Type
Regular

Shift Work
No