Dir, Project Management

39med

Analytical testing, development, transfer, and/or validation
Biopharmaceutical manufacturing industry experience
Analyze, interpret, and troubleshoot analytical data
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

  • Analytical testing, development, transfer, and/or validation
  • Biopharmaceutical manufacturing industry experience
  • Analyze, interpret, and troubleshoot analytical data
  • Scientific, technical leadership, and troubleshooting skills
  • Regulatory-CMC topics and regulatory compendia
  • Strong organizational and project management skills
  • Strong oral and written communication skills

Nice-to-have

  • Large molecule method development, validation, and/or transfer
  • Deviation management and change control processes
  • Laboratory data management systems (LIMS)
  • Software automation/digital systems

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
  • Familiarity with regulatory-CMC topics and regulatory compendia

Work Rights

Not specified

Tailored Resume

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