Bachelor's degree in biology or chemistry with 12 years experience
Experience in biologics or vaccines commercialization
Troubleshooting analytical data and method development
This role leads global analytical technical oversight for late-stage pipeline programs through commercialization and product lifecycle management
Job Summary
This role leads global analytical technical oversight for late-stage pipeline programs through commercialization and product lifecycle management.
The position requires establishing professional relationships with scientists in China's government and contract testing laboratories to ensure uninterrupted supply.
Candidates must influence the development of new chapters in regulatory compendia, including the Chinese Pharmacopoeia, and coordinate internal reviews.
Matching Summary
This role leads global analytical technical oversight for late-stage pipeline programs through commercialization and product lifecycle management.
Skills & Requirements
Must-have
Bachelor's degree in biology or chemistry with 12 years experience
Experience in biologics or vaccines commercialization
Troubleshooting analytical data and method development
Knowledge of Chinese Pharmacopoeia regulatory compendia
Direct interaction with government laboratories in China
Nice-to-have
Cross-cultural competence for international collaboration
Experience with LIMS and Veeva Vault software
Proactive service-oriented mindset
Strong project management skills for multiple tasks
Key Requirements
BS/BA + 12 years industry knowledge OR MS + 8 years OR PhD + 4 years
Experience in biopharmaceutical manufacturing and QC
Familiarity with regulatory-CMC topics and deviation management