Director, External Large Molecule Analytical

leHACK

Bachelor's or master's degree in biology or chemistry
12 years industry experience in analytical testing
Experience with biologics and vaccines commercialization
This role leads the global analytical technical oversight for late-stage pipeline programs through commercialization and product lifecycle management

Job Summary

  • This role leads the global analytical technical oversight for late-stage pipeline programs through commercialization and product lifecycle management.
  • The position requires direct interaction with Chinese government laboratories like CDE and NIFDC to ensure uninterrupted supply of biologics in China.
  • Candidates must facilitate rapid licensure and approval of commercial product extensions while influencing updates to regulatory compendia.

Matching Summary

This role leads the global analytical technical oversight for late-stage pipeline programs through commercialization and product lifecycle management.

Skills & Requirements

Must-have

  • Bachelor's or Master's degree in biology or chemistry
  • 12 years industry experience in analytical testing
  • Experience with biologics and vaccines commercialization
  • Knowledge of Chinese Pharmacopoeia and CDE regulations
  • Ability to troubleshoot analytical data and methods

Nice-to-have

  • Strong cross-cultural communication skills
  • Experience with LIMS and Veeva Vault systems
  • Proactive service-oriented mindset
  • Experience with deviation management processes
  • Leadership in global cross-functional teams

Key Requirements

  • BS/BA + 12 years, MS + 8 years, or PhD + 4 years relevant experience
  • Degree concentration in biology, chemistry, or biochemistry
  • No visa sponsorship available

Work Rights

Not specified

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