This role leads global analytical technical oversight for late-stage pipeline programs through commercialization of large molecules and cross-modality compounds
Job Summary
This role leads global analytical technical oversight for late-stage pipeline programs through commercialization of large molecules and cross-modality compounds.
The position requires direct engagement with Chinese government laboratories such as CDE and NIFDC to ensure uninterrupted supply of biologics and vaccines.
Candidates must facilitate rapid licensure and approval of commercial product extensions while influencing updates to regulatory compendia including the Chinese Pharmacopoeia.
Matching Summary
This role leads global analytical technical oversight for late-stage pipeline programs through commercialization of large molecules and cross-modality compounds.
Skills & Requirements
Must-have
12 years analytical testing experience
Biologics and vaccines commercialization
Chinese Pharmacopoeia regulatory knowledge
Government laboratory relationship management
Analytical method development and validation
Nice-to-have
Cross-cultural competence in China
LIMS and Veeva Vault software experience
Deviation management and change control
Proactive service-oriented mindset
Laboratory data management systems
Key Requirements
Bachelor's degree plus 12 years industry experience