80%.
Being early phase center of excellence, 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.

Your responsibilities:

Your responsibilities include, but not limited to:
 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.

What you’ll bring to the role:

 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.

You’ll receive:

Learning opportunity of comprehensive pharmaceutical analytical instruments, technologies, as well as a new drug development end-to-end processes. Acquire analytical project management experience.
Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, career development trainings, experience and growth with Novartis, a highly famous multi-national corporate.

Why consider Novartis?
750 million.
That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where, you are entitled the opportunities to explore the power of digital and data. Where, you are empowered to risk failure by taking smart risks, and where, you are surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

Global Drug Development

TECHNICAL R & D GDD

China

Changshu

SNPT Co. Ltd

Research & Development

Full Time

Regular