Director, External Large Molecule Analytical

Nerdgigs

Large molecule analytical sciences
Global technical oversight
Commercialization and launch support
This position will influence life-cycle management of our company’s commercial products and include a specific focus on support of local testing requirements for our company's large molecule commercial products in China

Job Summary

  • This position will influence life-cycle management of our company’s commercial products and include a specific focus on support of local testing requirements for our company's large molecule commercial products in China.
  • The position will involve direct contact with government laboratories and functions in China (for example CDE and NIFDC) in addition to Contract Manufacturing and Contract Testing Organizations.
  • Lead and/or participate on global cross-functional teams and work effectively with multiple disciplines and personalities to facilitate rapid licensure and approval of commercial product extensions for our company’s biologics and vaccines.

Matching Summary

This position will influence life-cycle management of our company’s commercial products and include a specific focus on support of local testing requirements for our company's large molecule commercial products in China.

Skills & Requirements

Must-have

  • Large Molecule Analytical Sciences
  • Global technical oversight
  • Commercialization and launch support
  • Local testing requirements in China
  • Direct contact with government laboratories
  • Establish and maintain professional relationships
  • Troubleshooting assistance for testing laboratories
  • Global cross-functional teams
  • Regulatory compendia influence

Nice-to-have

  • Service-oriented mindset
  • Proactive and timely communication
  • Systematic and thoughtful manner

Key Requirements

  • Bachelor’s Degree with 12 years of relevant industry knowledge
  • Master’s Degree with 8 years of relevant industry knowledge
  • PhD with 4 years of relevant industry knowledge
  • Experience in biopharmaceutical manufacturing industry
  • Ability to analyze, interpret, and troubleshoot analytical data
  • Familiarity with regulatory-CMC topics and regulatory compendia
  • Strong organizational and project management skills

Work Rights

Not specified

Tailored Resume

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