Dir, Project Management

MOBS Lab

Analytical technical oversight
Large molecule commercial products
Local testing requirements in china
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.
  • Influence development of new chapters/sections of regulatory compendia or updates to existing compendial chapters/sections including, but not limited to, those in the Chinese Pharmacopoeia.

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 technical oversight
  • large molecule commercial products
  • local testing requirements in China
  • government and contract testing laboratories
  • regulatory compendia updates
  • cross-functional team leadership

Nice-to-have

  • biopharmaceutical manufacturing industry
  • deviation management and change control
  • laboratory data management systems
  • 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
  • Ability to analyze, interpret, and troubleshoot analytical data
  • Strong scientific, technical leadership, and troubleshooting skills
  • Familiarity with regulatory-CMC topics and regulatory compendia
  • Strong organizational and project management skills
  • Strong oral and written communication skills

Work Rights

Not specified

Tailored Resume

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