Being late phase center of excellence, Novartis Technical & Research Development (TRD) Changshu (Jiangsu province, China) site is responsible for around 70% of global Novartis New Chemical Entity (NCE) project portfolio. This role is critical for drug substance synthesis and process R&D analytical 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.

Major accountabilities:

•Defining the analytical strategy for development projects, including analytical method development and specification setting according to ICH or Novartis guidelines

contributing to regulatory Chemistry, Manufacturing & Controls relevant dossiers

effectively communicating and aligning the strategy with local and global project team stakeholders.

•Writing, checking, and/or approving analytical-related documentation, including testing monographs, method validation reports, transfer reports, instrument qualification reports, and SOPs.

•Leading investigations of Out of Specification/Out of Expectation results and Deviations, writing investigation reports, and defining corrective actions and preventive actions.

•Following cGMP regulations and Health Safety & Environment standards, and supporting Novartis internal and/or Health Authority inspections.

•Bringing Data & Digital ideas and solutions to the team and contributing to innovations.

•Enriching the organization culture by providing and implementing ideas and suggestions and coaching/mentoring junior colleagues.

Minimum Requirements:

Work Experience:

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

•Masters with minimal 8 years or PhD with minimal 3 years related working experience.

•Fluent & effective spoken, and written communication in English.

•Strong inter-personal stakeholder management skills.

•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.

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