Director, External Large Molecule Analytical

Merck & Co., Inc.

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

Job Summary

  • This role leads global analytical technical oversight for late-stage pipeline programs through commercialization and lifecycle management of large molecules.
  • The position requires direct engagement with Chinese government laboratories like CDE and NIFDC to ensure uninterrupted supply of biologics and vaccines.
  • Candidates must facilitate rapid licensure by leading cross-functional teams and authoring regulatory documentation for product extensions.

Matching Summary

This role leads global analytical technical oversight for late-stage pipeline programs through commercialization and lifecycle management of large molecules.

Skills & Requirements

Must-have

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

Nice-to-have

  • Cross-cultural competence for China interactions
  • Experience with LIMS and Veeva Vault systems
  • Proactive service-oriented mindset
  • Strong project management skills
  • Experience with deviation management processes

Key Requirements

  • BS/BA + 12 years experience OR MS + 8 years OR PhD + 4 years
  • Biopharmaceutical manufacturing industry background required
  • No visa sponsorship available

Work Rights

Not specified

Tailored Resume

Cover Letter